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平成19年度成果報告書はこちら - JCCLS－特定非営利活動法人

Contents

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4. 228 EI E ES ls ES esd Fey Eh ESO Ea p E P Ey EE Ee ed zT
5. 20 D ID LC MS 3 OOo 40 HECTEF AST T4 AS1 1 HECTEF PS1 T Single ED ID LC MS T4 10 0001 2 3 0004 0005 0006 0007 0008 0009 00010 0 4671 0 5207 05497 0
6. 0 0000 UUIDDUDDDUDUDUDUDUDUDBDDBDGUDGUDUDUDUUDUDUDUDUDUDDUDUuDUuDUUUDU 20
7. T Pool D HECTEF ASIM T4 1 1 HECTEF CIT 1 T4 Pool Singel LE Pool T4 T4 Pooll Singe Pooll Single FTA ng d FTA ng d 20 20 18 18 16 16 141 14
8. PLE BGG 115 uds
9. 00 OU D Uu 5 eee E JEHETE IE Ese EST ESTEE TE EI ETE Ez 1E 0 00000
10. 5 83 575005 O 0 0 0800 ampoule FSH IS 92 510 JRecorrbinant 6OIU ampoule Ing 000 448 ood 336 210 DD ID D 00 694 0075 5001 250001 2 100 1280 16 0 UD Da 16 J OO0951000 1000 200 170010 21 1 1 5 0 5 0150n NaCI LOX6BSA pH7 4 1L 500m 100 0 2 0 00 2 0060 13 00000 ris BSA
11. VG SRC USP Levot hyr oxi ne 1250001 14 4 4 T4 USP T4 10 7 D VG 5 05 1 2 4 8 1m 13 A 2 1 4 m 1 B 6 0 04 12 4 8 Inh 11
12. Ea Esp PESE l 160000000000 U A HD BO l 200s 400 ADL 0 00 l
13. ooo DDD D00000 pusPmm 000 00000 00000000000000 FT4 0 000000000 mooo 00000000 D m npuserrnmn nn 200000 Hu momnnnn nun 000000000000 Manufacturer J 0000 M00000 000 358 2 D uuu
14. Monogyceride lipase Glycerol kinase ADP hexokinase 6 Dub 000 16 0 1 mL II O00 0 1 37 C 37 Q 37 C II 08 ut 1 00 035 5 340 nni L TAbs rrin OO 1 EL DE DI D 1 D D 00340 nni OO OimAbs2 ning OUD C i hL 160 L O10 L 37 C 5 0 8 mL Bicine NaOH H8 15 150 M 100 mM MgSO 2 nM 2 nM Cach 2 25 nM 15mM ATP 3 75 mM 2 5 mM NADP 3 75 mM 2 5 mM Glucose 3 75 mM 25M DOC 135 mM 9 M CoLipase 10 ug nL 6 7 ug nL 15 1 U nL 15 U rL LU nL 15 U nL 1 U
15. 20 0 0 0 0 0 0 04000000 P AMY 0 0 0 JCI ERM Let 0050 0000 0 cm 0 0 0 0 SD Jsce
16. 84 ay TGET EM dL E U 10000 20070 090 100000 13 000 15 300 0000000000000 DU Uu 2007 0 090 260 00 17 000 18 30 DU LDUD D U D DE DU U un 20070 090 270000 13 000 15 000 DH DB DO DO D DO UI 2007 100 080000 16 000 18 300 0000000000 DU 2007 100 090000 13 000 15 00 1 DO HD UD D UD D Uu 20070 130 D U 11 000 12 00 0000000000000 U 12000 2008 0 02 180000 15 000 17 000 00 BH BUD DU LI
17. UHH
18. U
19. 272 0 0 0 0 OOUU0U OO 000 DU uuu OOUU0U uu 000000 0 UO U uuu Recs icu a D UD DD Uu 0000000 FSH Ul O O U 0000000 LD 0000000 LW Ul 0000000 FSH OU 0000000 E2 Ul 0000000 E2 u UO 000000000 UO
20. 0000 O N B U DN 9 ID LC MS 00 O O00 0 ED ID LC MS 3 yd 9 HECTEF ASTIT T T4 51 1 Q HECTEF PSI T GSing 0 O 0 434 0 638 ED ID LC MS ED ID LC 5 ReCCS IFCC IIT 0 990 D 009 0010 0 9460 0 9338 0 9917 0 9726 0 9663 O x FT40 ng d FT40 ng d 10 10 y 0 3477x 05092 9 y 04764x 00613 8 R 09591 8 R 09627 7 7 L 6 6 E 5 Bs 4 4 3 2 04343 27 1 R 208753 1 0 0 0 2 4 6 8 10 0 2 4 6 8 10 ED ID LC MSTHECTEF ED ID LC MSTHECTEF FT40 ng d FT40 ng d 10 10 3 y 0 5041x 03029 al y 0 4835x 0004 8 R 09979 8r R 0 9924 7 Tk 6 6 cI 5 L 4 3 ac 2 y 0 5556x 1 R 0 9832 1 0 0 0 2 4 6 8 10 0 2 4 6 8 10 ED ID LC MSDHECTEF ED ID LC MS HECTEF FTA ng d FTA ng d 10 10 y 0 5185x 0 4357 R 0 9473 y 0 5535x 0 1484
21. a 5 116 000000 OOOO I T 1
22. D Uu UwWGQ 500000000000 LU LU 0 UU 00000 D 103000 00 D uuu O O U DU Uu 00 0 DU Uu U uuu U uuu OU 197 900000 00000000 D NISTOOOOO SRM 924a0 00000000 070 0000000000000 U D 00000000000 3000000 0 800 1 100 1 8 mmol L U 000000 x 1000 D 0000000
23. 101 OO 000000000 DU M700 0000 OU 00 00 0 BPO BGO 0 10 8 6 1 0 1 0 1 0 0 0 0 10 8 6 4 10 6 6 1 1 4 2 6 1 8 3 1 10 5 6 4 CRM 470 1 8 1 8 8 4 6 6 6 8 5 5 0 4 0 2 LE EE EE EF S 6 5 6 8 12 9 11 7 3 9 7 5 6 7 7 0 0000 000 3 2 3 3 10 4 8 7 5 3 6 1 3 3 3 5 UBL Lu tt 2 2 2 2 9 2 7 1 5 9 6 2 2 1 1 8 OO 102 0 0 0 0 0 0 0 0 7 7 7 y 101x 005 0 82x 079 y 1 03 012 6 6 6 0 976 m 5t 5 C4 r m4 c t Em E rca O 2 F 2 1 1 1
24. 0000 HECTEF 00001 0000000 HECTEF J AMGTI ooooo 000000000 Co Co Co 0 0 O00 0 000 000000000 nm 000000 000 0 1 0 000 CO UO O CRPO 0 00 0000 1 19 UHH 0 0 UHHH 00000000
25. OOOO E WA BG
26. 005 245 800 L H NNaOH 80 49 33 207 mj m 287 mg NADP 68 584 m 500 U nri 060 L 500 U riy 060L 500 U rr ADP HK 0 6 11500 U mL 6 06 5 my m 02 0 u moos 30 C OHG 815 100 0 L 4 Q 1000 L 12d mom 80 MESO 0 53 md 100 100 434 mj mom IIT 50m pd p 037 40 d an dn IIT C1 0 2D 10000 D 300 L 246 BID 640 L 50 4 q 161
27. 1200000 173 UD 0000 0000000000 00000 0000 00000000 d UDDDDDDDDDDDD D Oooo 5 1000 02 620000000 O00 63000000 61 700000 130 000000
28. 0 9981 1 0 r e 998 1 0000 0 RW 0 J 000 D DU D WHO rCRP rCRP QO00 910 0000000000000000000 147
29. 156 OU 95 9 5 Lot 6 8 6 JC ERMQ 56 0 0 JC ERM000000000000000000 13 000000000000 56
30. LU U UU DU D 103200 UO 00 D UO Uu 0 ul UO DU Uu OU 160000000 000 60 LU LU UO 0 180000 2007 05 289 0 0 130 000 159 00 00000000 140000 2007 07 109 0 120 309 149 30 KSP 7040000 U 150000 2007 09 189 0 0 130 000 150 00 00000000 16
31. D uuu espi E OOO L1 r3 L 00 000 000000 000 00 00000000 322 L 00 0 UO 0 UD D uu D uuu 00 0000000 FS
32. OU 2 1 0000 UHI 0000 2000000 p O00 J SCC 020202005 J SCC J 0500 D J DSDD 0 DIE ogna aD ao J SCC J SCC J SCC SCC SCC Jsccoo o0 0000000 J CCLS anm J CCLS Nal m pom EEE BR os OO00 free B I Ao D OMd 0 Dean 000 ooo poo r3 5 gap O0Creq AMY a P P 0000000 2 ee oe ooo p DOPE ooo ooo ooo 2 05 5 DEO SATI
33. OU OU 419 1800000 0200700 800000 uu 18 00 uu 000 2008 18 20071 Dri 2007 OOO 000 4 20070000 0 1 10 2007 OM 000000000000 0 00 bAr0 000000000
34. CIPM CCQM 5 SIO 1 5
35. 15 15 15 15 y 1000 x 0000 en n n Y 0000001 1000 0001 UDDDD y 0916x 0321 e00000 y cixsx 054 ennung Y 09 5x4028 e00000 y 0977x 0091 10 10 10 amp a a a c 5 5 0 0 15 15 0 5 10 15 0 5 10 15 menu memi 75 75 75 35 50 50 50 50 00 ege qae C Q0 eme se o eo C 20 eme asepe C 00 900 em O 25 5 10 15 O 254 5 10 15 25 5 10 1 25 B 10 15 o 50 o 50 o E j o 50 B 75 9 75 75 m 75 DON DOO 0 0 0 O menta moria menia menta enn nn 1 15 15 15 y 1000x 0000 1000 0000 y 1000 x 0000 y 1 000 x 0000 1027 0158 e nnn y 1020 x 0032 y 1012 x 0225 y 0965 x 0126 z 10 z 10 z 10 z 10 E gt gt
36. uggg CyeleQ JCTLM 16 UHH 0000 2
37. T4 468 98 6 0 70 000000 300000002u0000000 8 AS1 10 000 FT400 D 1 5 ng dL AS120 000 FT400 D 4 5 ng dL AS1 30 000 FT400 D 7 5 ng dL 000000 0 00000000000000000000 20000000 0 20 00000 0 0000000000000000 00 80 ut SD1 SD2 SD30 000000000003000 80 00 EI TUNES 740 FT40 87141 4000000 DD Im 100ul HEPES 0 pH 740 003 370 T40 00000 scer4g 00 00000000 1m 37 02q000 nnnnnnscerTannnnn Bcera 0000 00000 1 1 3c TA 0000 a dau a OTA 0 000 UVUUWUUOUUUUUU anananunnn a u HOR E I Hed Hie OO0 8CeT40 0000000
38. LU L 0 UO UU DU D 103200 UO D Uu 0 ul 0 OU OUOUOUUUUUO 160000000 UO 48 U LU 00 000 130000 2007 05 280 0 0 130 000 150 00 140000 2007 07 100 0 0 120 300 140 30 006060 150000 2007 09 180 0 0 130 000 18000 00000000 160000 2007 11 080 150
39. Passing Bablek 000000000000 DI 10 95 23 f us amp Shee vrai i m TERTE E een es EE BE D H mmol mal war i 0000 OU 1 Kouzuma T Usami T Yamakoshi M Takahashi M Imamura S An enzymatic method for the measurement of glycated albumin in biological samples Cl
40. D Uu D00000 52 21000000000 10000000 80 00 OU D Uu D Uu 9 9 40000WM00 500000 0 800000000000 200000000000 40000 1600000000000 100 000000000 16000000 0 2500 5 200000000000 9 1600000000 O o nu 410 80000000000 RANED 2000
41. 6aminoquinolyl Mhydroxysuccinimidyl carbamate AQOD O00 00000000000000000000000000000e 07 000000000000000 Conditions Column ZIC HILIC 2 1 mm I D x 250 mmf Column temperature 30 C Solvent A 10 mM Acetic acid B Acetonitrile 75 25 25 min gt 10 90 30 min 2 A B 75 25 33 min 145 6 7080000000 Flow rate 0 1 mL min Detector LC MS 201 EV Monitoring ion 90 00 L Alanine 94 00 Labelled L Alanine 132 00 L Leucine 139 00 Labelled L Leucine 165 95 L Phenylalanine 176 00 Labelled L Phenylalanine 115 95 L Proline 122 00 Labelled L Proline 118 00 L Valine 124 00 Labelled L Valine Injection volume 2 uL Sample temperature 4 C Time 88 min 222 08 00000000 Column Column te
42. DU 190 40 230000 200 10 170000000000000000 00000000 E 12
43. DU Uu 200000 FM4Q0000000000000000000 357 50 000000000 UUW co FI4Q 0000 20070 70 18000000000
44. DU Uu 0 100 20 xo Br D D DU uu 41 130 400 00000000 Passing Bablok 400 20 E 15 300 2 lt 200 25 i m 300 400 E o000 o AJ CCRM 322 2 L D J 322 3 0 o n9 A J CCRM 322 2 0 100 20 X0 40 JCCRM32 3 mean 25D UH g d
45. O00 6 aminoquinolyl N hydroxysuccinimidyl carbamate O O D Fluka Biochemika Ultra 0 0 0000000000 6 145 Q 60000000000000000000 500000000008 1 012 0 0083 226 NIST BSAQ IDMSO O00 0 oma MN OOo 0 000 0 5 6MHCl OOOO 146 Q 6O000000000 00 4QCOO0000000000000 HPLC
46. 206 0000 0 1 HDL CQOO0 W COOOOOU0U000000000000000 HBDLEC D D center for D sease Control and Prevention 1 I O O U U D ummugggaggggaggaggg Uu 0 0 0 0 OU ALECOOODUCOUCUOCOLE beta quanti fi cati on net hod 451 E Ea E Eje EN a EAE BQU 000 O00 50 U 0000000 NIST SRM 9110 NMIJ CRM 60010 JCCRM 224 0000 OO E SE ears HDL C nh 100 11 1 Onol LI 15009 4 Q 300 0000000 CQ A 0 10 9 20000 1900 L 0000 OQ LDL C NIST LC GC TLC 00000 OO 0 HDL
47. 3 58 00000000000000000000000000 5 363 6 7 DUDUD
48. a eG ae C r EX ES EE E II EA ELI Eg OOOUO00 C5 weg oOd0000 U E20 LH U EEE EJ DU OO 900000000000 00 OU 301 L 00 000000 00000 DU OO uu U UUDDUUUDDDDUReCS U 0000 U uu D uuu U D uu UO
49. 9 0 5601 772 18 4 0000 QOO0000 0 OH No Ib LOMS D ODA 0 008 DOC 0000 HBOE a GF fO dde d ODH 000I 9 1 11 1 12 0 21 2 20 0 22 2 22 0 24 0 23 1 13 3 17 1 12 0 17 8 29 596 10 2 23 8 22 7 37 2 20 0 37 6 39 1 37 0 33 8 23 0 27 9 18 5 30 1 25 6 12 4 68 1 44 5 73 4 77 7 71 8 68 4 72 5 65 5 67 3 71 0 59 0 67 2 13 3 15 7 127 5 79 7 112 5 133 8 132 3 135 8 103 0 117 5 128 2 135 5 104 0 119 1 15 0 17 9 177 9 112 6 137 0 155 5 188 3 158 5 142 0 151 8 169 7 169 9 145 5 155 3 13 6 19 11 226 0 159 8 192 7 241 1 306 4 201 9 198 0 215 4 233 1 240 8 191 0 218 8 17 5 22 14 335 9 238 2 291 6 331 7 469 0 310 1 298 0 266 1 380 0 379 8 296 5 327 0 19 5 25 17 345 1 291 0 318 1 466 7 504 5 328 1 358 0 379 3 410 1 409 5 323 5 375 8 17 6 29 21 650 3 483 4 542 0 670 9 830 5 551 2 549 0 505 4 704 7 730 4 567 5 616 9 17 6 30 22 728 1 511 7 567 8 745 1 905 4 60
50. 18000000000000000000000 1 D 0000 L 6
51. 407 B2MG 096x 005 B2MG ly 097x 005 BMG 000000 099 012 DITNo 1 sD 00 000 09 R 1 00 EA 0 000 0 0 09 R 100 RUE DITNo3TIDvsn D DD 000 00 R 100 50 50 40 ai 040 0 40 a 0 0 D E Pa W p d N N o 20 20 o 20 110 210 310 0 0 0 0 10 20 30 40 50 0 10 20 30 40 50 0 10 20 30 40 50 000000000 mgL 000000000 mgL 000000000 0 10 20 30 40 50 0 10 20 30 40 50 myL mL 0000000 0000000 B2MG 000000 097 029 BMG 000000 084 023 B2MG 104 007 fet DITNo4 TMS n 00 000 n n 09 R 100 5 5 D 000 D O R 100 R 10 50 50 50 40 0 40 ill je N N 020 20 o 20 410 510 ent 610 0 0 0 0 10 20 30 40 50 0 10 20 30 40 50 10 20 30 40 50 myL mgL 0 10 20 30 20 50 0 10 20 30 40 50 000000000 mgL mgL mot L B2MG 000000 098 005 B2MG 0 99x 038 BMG 084 2 7 5 D D R 100 m
52. 0 0 0 434 0 638 0 0 0 0 EDIDLQ M RA
53. 402 8 3000000 janua 252381315355 EENET ae I Paka Gap bee Coe Ea Dal F AREN VERTI ECCE 405 404 A B2MG y 098 017 M ENG 098 lt 016 BMG 00000 100x 000 DITNo1wsD 0000 00 R 100 DITNo1wsD 0000 09 R 100 my 0000 09 R 100 50 50 50 ne ee 0 a D D 40 1 2 30 30 we N 20 o 20 o 20 110 510
54. 150 AR OO WU 180 1000000000000000000000 LA 000000800 2 5 4ydgv 265 00000000000 900000000000 151 6 0 5 0 4 0 3 0 CRP m e dl 2 0 1 0 0 0 6 9 12 15 Storage period at 2 8 C Month nnnnnnn tom oo wass nnnn OO 152 18 900000000 900000000 1 000000 0 14 MNG 2 nMCad and 0 05 000 20 nM Tri s Hd 5 0 00000 O00000 r PU 45nd 1
55. 00 0 0 0 0 0 0 281 0 1 00000000000 10 10 p 000 50000000001 o2 mLmini 1000000000000000000 OOOO
56. 0 0 Agilent 0 6890 GC 5973 MSD inert 00000000000930 WOO DB 5ms 30 m 0 25 0 25 0000000 0000000000000 00 000000 00000000000000 3000 00 000000000000 3000 0000000 00400000000000000000000000000000 oup 0 D uuu 5 5 90000 Abundance 463 450000 400000 350000 300000 169 250000 200000 69 150000 405 489 504 100000 7249293332 369 4 L 36 LL 4 crt 0 200 250 300 350 400 450 500 550 600 650 700 750 800 miz 50000 NT 50 100 15 O09 288 19
57. 0 01 0 02 0 00 0 000 OOOO 5 5 60 0000000000 0 09 0 1 000000000000 HPLC UV 1 5 5 8 5 5 nm U 04 nm Ed 1 EE E EJ E EET EET Ea EL EJ 0 0 nm EL AECISUEST 5 5 Ep SEEDS ETE EI 232 D Uu
58. 104 000000 lt 0000 ai na nad ag pna drm d uuu uu lt 110 720 50 cx0 300 LCMS 0 08 H HFBA 0000000000 OShim pac VP ODS 2mmx 150mm 00 08 HF BA BOO 00 0500 0000 000 000000 o2m mn 1 1 0 0 0 nono NST 5 927410000 200000 3 3000000000 wo 0 7 3 30105494 0000 5 OO D00000
59. 1011200170 0000 n a ed m o m o a 8 ooo o io a 8 to 8 06 227 1 007 0 0260 0000 NIST BSAL D D HL BH 0 0001 D 00000000 0000000000 6 145 6
60. a BE HERE BEBE 283 Ll oo oo 000000000 0000 00000000 00 0 00 0 5 1 DUDBDDDU 00000 00000 00000 pco joo Og E A 2 1 5 80 55 L M 00 2 242 28 271 305 162 2 214 22 5 577 82 621 738 412 521 54 2052 334 2219 234 226 518 793 5913 664 62 20 1999 27 14531 23413 21427 00 099 152 114 141 085 116 10 000 068 101 066 139 187 080 050 02 01 118 085 0 090 n 111 Dj 2 2 4 5 80 55 jud Aa p aS 0 01 0 0 2 00 22 5 2 20 219 50 55 2 200 1886 256 DO 0000 000106 069 1 104 108 Ymon 000 015 4 092 069 1 104 108 POPP r r L Cojo x BIO 3 15 15 96 60
61. 0 810 1 260 0 0 1000000000 16 5 00000 20 0000000 000 DU uuu
62. 945 9000000 DU Uu UUIDDUDDDDDDDUDDUDDBDDBDUDUDDUDUUDUDDUDUDUDBUDUBDUUDUuDUuDUUUD
63. E T mE FE Ea Ea iD 9000000000000000000000000 UD DD D 000000 5 56 Lot 0050 U U Lr IT ES 81 GERE ERE EST SE ES SES LEES ESI E SESTO nm Lr 2000000 10 157 00 1
64. 0000 WHO U ll 1st International Standard for BETA2 MICROGLOBULIN Code B2M 0 14mgLO0O 0000000000 90000 e e e e 0A000000 380000 2 e 140 170000000000 18 U e 0000000000 00 000000 000 00000 0300 OO 21 30000000 U 400 000000000 1600000
65. 234 DU Uu UHH OOOO 00 00 00 0000 46 973 2002 D E B Oliveira E C Gotschlich T Y Liu Proc Natl Acad Sci U S A 74 3148 1977 DU 00 00 235 UH UHH 0 U
66. 87 1 jl Psat X INE JA No 9 OO 00 00000000 UAH 20 C 70 0 QVO00 2 q 2 600000000000 HDL C 6 8 mg dL LDL C 14 Nol 20 Q 000 88 LDL C 20 C 89 70 200 0 Q 0 600 0000000 No 1 0 20
67. 00000 IRMM ERM DA470 CRM470 00000000 0606 Q 6 OO 1800000000 1900000000000000 00000000000000 OU 60 p 255 18 U 5670 992 DUD 0 Du 000000 000000 000000 DUD U O DUD U O 000000 DUD 000 O00 O 0000 JCcLSO 10 00000 uu 2007 10 30 BMG 000000000 BMG 000 U U D Uu U 0 OO WGQOOUO0000 00000 00000 00000000 000 c9wcr J 000008 20000000 OOOBMGIDO0 2 0000000 18000000 15 200 e Brn 0000 0 WGBMGOOMO 20 0
68. 0 658 1509 00000000000000 WOOO 161 00000000000M00000000 No IDLCIMS D ODA 000I 1 9 000 1 11 1 18 7 24 8 20 0 21 5 25 2 30 2 34 4 11 7 14 9 13 0 20 5 39 2 10 2 23 8 35 5 43 5 20 0 36 4 44 8 46 5 50 3 20 3 24 4 20 0 34 5 33 6 12 4 68 1 69 5 85 9 79 6 69 6 78 3 91 1 97 4 59 4 62 1 63 7 75 0 16 7 15 7 127 5 124 5 131 6 137 1 128 1 155 5 129 4 174 8 113 1 118 4 112 2 132 0 14 0 17 9 177 9 175 8 160 2 159 3 182 4 181 6 178 4 225 8 149 8 148 5 157 0 172 4 12 6 19 11 226 0 249 6 225 4 247 0 296 8 231 3 248 8 320 4 205 7 210 4 206 1 242 5 15 2 22 14 335 9 371 9 341 1 339 8 454 3 355 2 374 5 395 8 335 4 331 9 320 0 359 6 10 7 25 17 345 1 454 4 372 1 478 1 488 7 375 8 449 9 564 2 361 9 357 9 349 1 417 9 17 4 29 21 650 3 754 9 634 0 687 3 804 5 631 4 689 9 751 7 622 0 638 4 612 5 679 7 9 5 30 22 728 1 799 1 664 2 763 3 877 0 697 9 834 4 805 9 690 7 699 2 702 0 751 1 9 2 32 24 1235 4 1432 4 1095 7 1409 7 1437 5 1086 0
69. 0 0 00000000000 Pool M O HECTEF 51 T T4 AS1 HECTEF T HECTEF PSI T T4 CAL T4 Pool LT Pool T4 Pool Single Pool Single HECTEF PS1 T4 ng d FT40 dl 8 y 0 6807x 0 4389 TF y 08173 012 R 20 9905 R 0 9934 y 0 8191 y 0 7795x R 09297 5r R 0 9902 5 4L m HECTEF 51 a HECTEF 51 HECTEF C1 3r HECTEF C1 HECTEF PS1 HECTEF PS1 CAL 27 CAL CAL CAL Poog 0 lr Poog O singled 0 Singe 0 3 00 Poog 0 0 Poo 0 00 Poon D 0 2 4 qe 00 Poon D FTA ng FT40 ny dl 8 y 1 3 0 0948 7 y 0 8743x 0 1406 R 20 995 R 0 9968 y 1 3299 y 0 8299x R 0 9942 5 R 0 993 e HECTEF AS1 a m HECTEF Cl m4 HECTEF AS1 A HECTEF PS1 HECTEF C1 x CAL 3 HECTEF PS1 x B CAL CAL e Pool 2 B CAL Singe 0 Pool O 00 Poog D t singel Me Pool 00 Poog 0 0 0 2 4 6 8 0 2 4 8 FTA ng d FT40 ng dl 8 08112 02241 5 11441 00904 R 0 9989 R 0 9997 6 y 08819 11156x R 09876 x 5 0 9988 E 2 oO 4 e
70. 8 OOO 964 1 00 200 20 18 oo000000 0000000000 213 0012 3 2 1 KSP R amp D A205 TEL 044 813 0055 FAX 044 813 0224 1 Clinical Laboratory and Standards Institute CLSI Measurement of Free Thyroid Hormones Approved Guideline CLSI document C45 A 2 Katleen Van Uytfanghe Dietmar St ckl Alec Ross and Linda M Thienpont Use of Frozen Sera for FT4 Standardization Investigation by Equilibrium Dialysis Combined with Isotope Dilution Mass Spectrometry and Immunoassay Clin Chem Sep 2006 52 1817 1821
71. 219 4400 2m 000 n 5 jn 0 14M NaCl 2mM n o erm ono O O OO em 000 0 ID MSII U jn Tris HCl 0 14 M NaCl 2 mM CaCl 0 05 NaN 000 Bau ekg 00 OOOO U gkg CRP umol kg nnn HU U 26000000 5 1500 0000000000000 5000000000 60000 05 00000000000000 Conditions Mode Decompression Accessory ASC 150L Gas flow O 500 cm min 200 cm min Heater Set temperaturel 600
72. 20 4000 FO 80 100 80 100 20 ggr 80 100 0 20 40n g FSO 80 100 5 b n gu F 9 4 8g iu E gnm intercept Siope 0000000000F00000000 880 o041 n A B D E G H No mi LLLI CV Min Max 1 IN 1 724 _ 810 830 5 69 72 651 746 648 507 6 90 126 5 69 830 2 IN 2 1948 2180 2193 18 63 195 18 64 20 62 18 22 12 55 1904 76 1822 21 93 3 N3 85 42 10 43 76 35 80 378 3729 3951 35 28 2462 37 13 79 3528 4376 4 IN 4 6005 6320 67 28 5287 594 59 32 6152 53 73 40 50 57 61 82 5287 67 28 5 IN 5 8422 82 1 83 48 89 35 77 30 60 72 82 77 58 7730 91 10 Slope F 097 100 105 intercept 053 073 030 Corel 09999 10000 09996 00 724 6 89 6 39 746 6 85 724 760 7 37 6 91 897 7 30 55 6 39 7 60 1948 19 75 1904 2064 1948 19 36 1947 1986 1981 1936 19 64 24 19 04 20 64 3185 38 80 39 30 38 22 38 27 38 01 3745 3780 3856 3611 38 06 15 37 45 39 30 60 05 58 60 61 13 5552 60 46 60 03 59 66 58 69 58 83 58 16 59 01 29 55 52 6113 g 000 8422 84 79 82 97 87 00 83 77 8419 84 65 8511 8472 8623 84 83
73. 0000 U U traceability champ 00 000000000000 Iso 17510 00000000 000000000 0000000000000 000000 150 181531 0600000000 00000000 00000000 501 5 primary reference measurement procedure OOO 4i H1 B H H HH B BH B HH B B U U primary 5
74. 208 D Uu 204 205 0 U CTEF 00000000000000000000000 OOOo00g0g00000g0 00000 QS Cinical and Laboratory Standards Institute UO O vali dati ong
75. Eu Ez J L E T Es 0 0 97 170000 OU 98 UHHH OU
76. 000 000000000000 1 1 SDS PAGE 23 kDa O00 SDS PAGE 000000000 O0010 QMO000000 D U D D D uuu 1000010 10000000 153 o 0000000 2 0000000000 1 0 0 2 mg mL ll 0 915 mg ml J 154 000 0 UUDUDUDDDDUDBDUUUDUUDUDU D uuu U uuu 7 sDul HB 0000000 e 000000000 52 mg mL 9000000 155 000000000
77. 0000 2002 BIPM 00000000000 IFCC OU Symposium on Traceability Laboratory Medicine JO 0 0 0 L L 0 0 Bureau international des poids et D D Comite international des poids et mesures 0 0 0 0 D L IFCCI International Laboratory Accreditation U U L U U U Healthcare 1
78. 119 0 9993 LI 1002 0 01 HPLC BCG 0 OW 0000 O Hy L 00000000 D0 DOOD D 15 100000000000000000000000 01 0000000000000 001 002 003 004 005 006 007 Ooodgag 181 238 3 12 3 54 444 494 5 40 SD g dQ 0 099 0 104 0 134 0 097 0 128 0 099 0 160 oq D D 5 5 4 4 4 3 2 7 2 9 2 0 3 0 3000 1 20000 nari 15 34
79. BB RI R2 R3 R4 R5 0 1 3 1 1 2 8 20 2 2 1 0 0 3 40 5 5 10 4 0 7 80 7 6 6 8 3 7 160 11 10 9 11 6 11 320 7 7 8 6 6 4 640 5 7 2 6 11 5 1280 6 5 7 6 9 0 2560 4 4 4 5 8 3 000 2 1 2 3 5 2 R Ug 1030 718 1020 1293 1765 501 1264 312 11 262 734 529 0 1460 0 8100 0 1210 0 0019 0 0958 HEPASERA 1 Ri R2 R3 R4 R5 0 1 1 1 1 2 8 20 0 2 2 0 2 0 40 8 7 10 9 2 3 80 10 7 9 8 6 10 160 9 9 6 12 9 6 320 6 9 7 6 9 10 640 6 6 4 4 8 4 1280 7 6 9 6 9 4 2560 2 1 1 2 1 2 000 1 2 1 2 2 3 653 693 830 660 687 767 169 LU LLL 40 177 8 34 114 04859 04133 08930 08009 03259 Hol Ri R2 R3 R4 R5 0 1 3 1 1 2 8 20 0 2 1 0 0 0 40 7 5 10 4 3 3 80 8 6 6 8 6 7 160 7 10 9 11 6 7 320 9 7 8 6 1 11 640 6 7 2 6 9 4 1280 8 5 7 6 8 5 2560 1 4 4 5 3 0 000 3 1 2 3 2 5 R piii 841 718 1020 1293 882 1002 574 122 179 452 42 162 0124 04153 00555 07777 02638 245 00 0000000000 HEPASERA 1 00 wll ELI 2000 NR4 0 0
80. DSO 0 55 LE E n Oo EE dE 0 mmol molQ 000 D OiFCCOOOU EASDO IFCCOOOUO 400000 OOdJDSOO 50 00000000000 Nesri ODO D 1 1 1 26 Oooo
81. U 10 000000 240 000000000000000000000 1 07320 1 226200 U 0 9560 0 9980 0000000000000 UIDDDUDDUDUDDUDDDUDDBDDBDGDUDDUDUDUDUDUDDUDUDUDUDBDUDUGuDUDUUUUDU 0 Jr eats EE 100 A 080000000000 5 13 0 0000000000000000 VAUD O um sae ee n 74 GIHE OOLLA 10 20 30 40 50 60 7 izae 00 1 0 00 2 amp 50 3 A CD d 8 00 5 Oft ES ES amp X B1 00 EL 15 o 0 10 20 30 D 40 50 60 70 900000000000 i BE 0051 0 10 20 30 40 50 zE D SHH 60 70 13 12 11 10 09 EE GIHE 0051 0 10 20 30 40 50 60 70 D UUIDDUDDDUDUDDUDUDDBDDBDGUDUDDUDUUDUDDUDUDUDUDBDU
82. LU LU o D Uu U uuu D 10 65 L Uu 00 00 DU UOOUOUOUU 000 Du 00 000 238 00 OU 00 U uuu Uu OU 00 00 O O U U uuu 00 DU uu 000 D uuu Du 00 DU uuu 00 U uuu 00 D uuu 00 UOUUOUUU0UO 00 D uuu 00 D Uu DU Uu 00 0000000000000 U uuu 00 00 D O U 00 D uuu Du 00 D 000000 2005 11 070 00 180 000 150 00 00000000 D 000000 2005 12 07 00 10 000 130 00 00000000 D 000000 2006 01 17000 130 009 150 00 00000000 D 000000 2006 03 109 0
83. UU ELE EI E 237 UHH 0 0 UHHH 000000 ANA OU Ed SEI ES pep ECT EST OOO ct L1 Ey GE OOO ct OOO oO E LT EE E OOO Oo t To cp Ep ESSE E E 0000 8 8 WHO a 1
84. HPLC BCG 120 BCP Ag BCP 4 5 BCP D O DA470 OO 15 M ERM DA4700 O D 0000 121 OU 5000000000000 00000000000 HCIEF Jeasnp n 560 0000000 00000000000 000 000000000000 RPDHDUDU JASN 0 Ei Ei ng 0 0 0 111 1 1 mm OO 000000000000 UH 15 Picy I D 81 1800
85. 000 1
86. 200 5 D uuu DUBHDUDUU OU OU E st Es ES FEN E E FES C ERST EET E UE SERT EE E E a SES EST ERIS CERE es 190000000 00000000000000000 D uu 20
87. 00 1 Sampson et al Coupled Enzyme Equilibrium Method for Measuring Urea in Serum Optimization and Evaluation of the AACC Study Group on the Urea Candidate Reference Method ClinChem 26 816 826 1980 2 NCCLS Method Comparison and bias estimation using patient samples approved guidelines Document ISBN1 56238 283 7 1995 NCCLS Wayne PA 3 Passing Bablok W J Clin Chem Clin Biochem 1983 21 709 20 1984 22 431 45 47 UHHH 00000 18000000000 0000000000000
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141. 215 uu uuu uu ru aT e nn too Ton too oo too Tou i U ni 2 44 LH D 1 1 3 03 15 212 166 22 207 172 LH D 2 6 10 36 259 4 69 392 48 464 396 Ojo N 8 00 481 101 694 7 3 20 1 77 193 47 365 466 18 19 154 140 16 82 153 14 97 D 3 4 5 13 57 17 24 7 2 14 84 8 1 7 04 618 12 7 14 56 16 4 15 75 12 42 92 1064 115 13 4 1233 957 145 10 7 15 7 12 08 64 547 686 12 71 15 41 9 18 11 94 118 1L32 14 92 204 247 2274 117 C3 o LHO LHO 11 5 13 85 17 4 24 91 18 5 26 44 23 8 296 19 8 15 17 12 95 16 39 14 5 12 47 15 05 23 5 23 71 21 91 25 5 23 6 18 97 2223 32 4 26 67 25 11 28 38 24 1 22 73 24 95 26 01 14 2 0 32 6 45 99 221 418 466 41 73 35 95 45 98 423 32 09 3971 55 1 8165 474 698 77 5 72 24 66 69 7211 702 59 51 68 64 0 94 11 10 0 94 100 0 59 0 92 098 1 03 39 27 18 7 67 80 141 0 99 24 8 2 92 285 277 2 79 27 237 265 2 79 165 4 82 0 8 2 1 43 277 3 87 472 6 39 5 3 4 62 216 4 30 65 460 5 04 4 372 492 586 80 604 608 11 10 67 118 118 129 12 16 1108 1162 11 3 50 4 68 419 583 6 96 11 61 123 12 3
142. 210 1SO1IEC170250 00 1500 00 4 ANTE Reference Mt eri al Institute for Qi ni cal Chennstry Standards 5 0 000 1000 c 000000 5 00 1 Rifai N V rni ck CR Domni czak Md Handbook of Li poprotei n Testi ng 2nd Ed pp221 263 AAT Press 2000 NAS C37A Preparation and validation of conmat abl e frozen hunan serum pool s as secondary reference naterials for cholesterol neasurenent procedures Approved gui del i ne 1999 211 UHH 000000000 LU 1
143. 351 OU WOO 12 1 OU OU 0001001 WOO 41 8 0000000 87 1 090 00000000000 222 00000000000 UIDDUDUDDUDUDGUDUDDUUDUUDUDUDUDUDUDUDUDUDUDUDUDUDUDUDUDUUDU 12 2000 1000000000000 0 3 O HECTEF ASI HecreF PSINOOOOOdO0 D Uu 5 020000000000 00 0000000 0 434 ED I D LG 131 0 638 OOOO0 PGSO00
144. 39d DO0000 e 000 30 QOO0000 SI B 100 U Ud 97 900300 3000000000 100 200 200 CRMI7O U 4 B uu ogg BPI BO U 90000 300000 7 500 BGO 9 20000 evuuguuu 2 216500 2 0167 0000000000 WO 9 20 12 9 7 7
145. OU E r E ESI HPLC U 0 m ET E E EE uU D umpnaaagagaggagmmmnpunHPLCUVUTQDEG UU 11 17 21 trihydroxy 5a pregnane 3 20 dione 5a dihydrocortisol 11 17 21 trihydroxy 5B pregnane 3 20 dione bB dihydrocortisol 4 pregnene 11 17 20a 21 tetrole 3 one 20a dihydrocortisol 4 pregnene 11 17 206 21 tetrole 3 one 208 dihydrocortisol Lr 000 DU Uu D Uu EE EE 000 D uu 000 000 D uu E E uE 11
146. 3 10 1 28 MP 1 43 300 50 ny L 339 2 17 6 ng L HBS D U HIV LI 000 HCV HBc U Tereponema pallidum 0 HTLV U OOO 000 7 10 128 00 143 0 10 OOO emn 0 000000000 Prototype Prototypel 0 0 0 D Uu 130 000000 0 0910 0000 ghrp O00 Hitachi autorsted analyzer model 7170 u lU 0 0000000 CALB O Sysmex Corph D Uu Prototype 0 00000000 ISO Guide 35 BCR report 0 0 0
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148. Drm Se LLlu 0 180 120 4 190 10 12000 18 20 20 28000 30 10 UH 0000 U S 50 SO 000000000 00000 66 716 0000000 BAbs T AMYAbs 0 TAMYAbsx BAbs 0000 SAMYQOOGUOGUUOUO TAMYAbs OOO 950 00000000000000600 UHH
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151. 242 HEPASERA Le oe h Ho 30 30 30 160 Sp 30 30 64 1260 0 320 Nu 3 32 1280 160 Dissp 320 0 320 1280 160 HEPASERA 1 R1 R2 R3 R4 R5 Ho 320 1 1 1 1 2 2 5 320 1 1 2 1 4 1 2 1 Nu 320 1 1 1 2 1 4 2 Dis s 320 1 2 1 2 1 1 4 2 HEPASERA 1 Ung B 100 0 103 0 99 8 100 0 97 0 5 101 0 102 0 100 0 100 6 100 0 Nu 100 0 103 0 99 9 100 4 94 0 Dis s 1000 1030 100 1 1003 97 0 900000000000 000000 100 1 U Speckled QO 249 0500 0410 100 90 80 70 60 50 40 30 20 10 0 0000 0 0 0 0
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153. 43 7 B 000 D 2007 06 139 O 0 13 000 150 00 00000000 44 100000 2007 07 249 0 O 13 000 140 00 45 0 0000 2007 12 06 0 13 000 140 00 00000000 46 OU O U U 2008 03 05 O 0 13 300 150 00 00000000 385 90000000000 0 00 18 0 140 1700000020 15 1600 190000 700000000000000 24000000000 9 1s000000000000000000000 05 1 00000 50 JU H DB 5 NIBSC THE 1st INTERNATIONAL STANDARD for BETA2 MICROGLOBULIN Code B2M 980 900000000000
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155. 0000000 00997 1 0000 0 00010 1 1 ogogo ggg Ls ssp ae sep Sus SUI Ss amp 2 045 Zi E 25 2 06 E 3 81 s 057 z 345 335 0 0 431 1 04 43 NINININININININININI P ka EE off ff fe sbe cja 1 11 132 122 207 131 EI 138 133 FA 177 163 205 192 197 195 209 20 198 217 198 E 205 014 23 19 395 x 461 n 41 489 45 5 71 5 15 97 55 SD 2 1 02 SD 3 167 SD 4 175 i N m mimi im e m D unu tD B p dau FTA 0 ng dL FT40 ng dL 7 20 i 18 xe 25 2 af 0000 16 5 m 0000 14 Y 0000 A 0000 ag t 0 000 4 0000 D 000 x 0000 10 A x0 S e nun Y x0 O00 0000 en 000 2 0000 06 i 0000 ou 04 0 000 1 O 0000 0 000 eet 0000 02 00000 0 00 0000
156. 00000000 0 2 mmol 00000 0 0 0000 5 7 15 30 p t0 B B U U U U U U C CL O 7 UO 1 UH u U 0 328 18 120 1 27 H g dL E 587 032 2150 048 mol L U 0 95 00 00000000 0 2 0 U k Uc 50000 252 0000000000000 00000 70 q 0 1030 6 e 0000000 70 QI 20 Q 0000000000000 120 00000600 38
157. 6 172 15 gt 700000 gt 80 000 5 90 1 2 00000 138 7010 0 20 00000000 500000000 166 0U 3 590 0 020000 00060 0 9 00 000000 0 7 3 2
158. Lp SE EI Oooo 120 2 00 0000 000 BPO 3 32 000998 O O 0 996 0 03 L 3 17 000994 0 984 0 07 L 3 32 000998 0 999 0 O2 L 3 25 000999 1 0 949 0 12 BOG 300 0 3 69 000998 0 923 0 64 100 3 92 000995 90 0 9119 0 91 2 87 000993 0 803 0 2 PLE BGO OOOO 3 39 D L 15 210 0000000000 PLE BCG 1000000000000 000000000000000000000 5 15 OOO 10000000000000 B800 95000 9 7 101 19 0 0 0 ERM D4700 00 99 4 1029
159. UU 1 ui D uuu 2000000000 0 76 1310000000 3 220 250 0 4 952 E E EJ EI rr E ET EE Eu ESSI ESSE u EI L1 Edy USES Lr E Ea EE as GE Ee EE ET Ez ES GE ES EE EE ES ES ET EEE E ES EIEN EE EC 1 1 SE Y E E EST ET SET E ESTs EE ECTS EET CEST iE E ed Dnugnnuuapnuunuunugnud 0800 10 130 0000000600
160. 3000 1000 2000000 118 UHH uuu 0 6 0000 1 5 2 5 35 45 55 OO 3 0 0 ITIH42ITJ0 15M Brij35 D 24 03 0 0 O 38 15 35 8 Oo 5000000600
161. 5 2 l 120000 12 9 900 1100 0000000000000 110 120 180 140 00000 000000 304 Manufacturer Manufacturer Fel Be Be End user
162. Dxn 03 15 25 4 op op cnm e p sp n J mo cm na gt 0 13 0 40 0 62 1070 63 566 661 63 69 776 413 652 542 i 3350 2397 2677 2683 260 249 5269 1821 2335 2250 1581 D4 63 1270 118 17 11630 12439 oooo0 311 DER 50 SD 30 29 M 30 31 32 vis 21 x 31217 no 35 47312 5 36 73257 D 5 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 10 44 195 1057 No D 11 39 8411 204 22 29 12 40 16 526 210 43 68 s 26741 220 7081 180 160 140 120 100 0 000 0 4 Y 1 185 22277 248 i 188 35138 I 199 080 0 60 0 40 H 1 K L 0 77 1 38 0 93 0 99 1 03 0 11 117 0 95 1 14 122 100 0 54 1 23 0 54 0 10 0 29 0 68 0 9933 0 9967 0 9990 0 9954 0 9984 0 9985 0 9990 0
163. 000 00000000 U LHOFSH 050000 0 0 0 0 150 Nacin 1 0 BSA pH7 4 0000 1L 500mg 000 17 0000000000 2 0 00 2 0000 0000 13 000 00000 Dris BSA 0 am e n OOOO0 00 00 00000000 00 00000000 Tris 6057410 0 0 08000000 OO 0000 876600 0000 00 0000000 00 009 73000000 00 0000000 0 5 10000000000000 000 0 950 minim UU 00 0000000 00 0090 74000000 00000 mum uu OO 090000 0 074 0 1 0 00000 0000 0 LHJFSH 0000 000 0 DLHIFSHIDD D 300m 297 000 00000000 2ndiS 80 552 2na IS 80 552 0 3 1515 96 602 4 1515 96 602 0 8 OO 00000 2nd
164. 00000000000000 400 50 00000 ED ID LC MS FT4 ED ID LC MS 0 OOOO O00 100000000 Run 170 168 Run 751 783 Run 745 771 162 nd ii Run 912 i 853 PSO Ham 807 826 849 47 4 36 Run 185 195 nun Run 198 193 193 25 tal Run 139 152 nun Run 137 147 64 101 Run J 3 41 345 00 Run 353 381 355 aa ila 10 30 E USB 4 eee 5 e NN EL gi lo a d pessceesscg Ass y 1 225 0 0789 a R 0 9992 ua 0 541 0 2014_ 0 0 R 0 9974 0 0 05 10 15 20 25 o 000 T4UCeT4 0 2 4 6 8 10 ED ID LC MS rg dl 000 000 OO ED ID LC MS 1 U CD B Hl C U U U DI U FT4Q00000000000 Uu HH H U BED ID LC MS H H B d B CE B C B CH U UD 0000100 00500 00000 0000 08000 0 90 000000000600 366 D UL M0 3D BUD 0 D BO D CV
165. 2 DHbA1dT 0 00 NGSP B DE D 00000000 0000 5 1 01 2 57 01 000 3 7 4 02 000 4 94 0 2 000 5 113 03 HbA1c I 0 D B E E D U JUniv of Missouri O O Univ of Minneapolis Core Lab for Clinical Studies 40 0000000 OO NGSPD 000000 00 0000 000000 00 00 00 00000 0 UNESP 00 0 Nesp 00000000000 00000 30704 OOO 000 4914 qu 0 00 O O O 0 19 0 20 0000000 0000 0 004030 OOO 00 0040 0 p ag gg d an 000 5 0 00000 UNESP 00 0 0 000000000000000 000 00000000000 6 020 00 00 0000 000 000000000 D NcsPhpnag 00000000 00 000 000 32 113 94 9 24 10 86 74 727 57 51 513 569 DU nk 74 94 113 5 7 5 1 5 12 5 67 7 25 9 21 10 85 3 p Os E mo dg L3 RH Ir i 1 x q
166. D uu DU Es oy ES ES ET Ea E I L Ey 00000000 BH m J gJ Lr r3 r3 Hood ES So 5
167. 0 0 15000 2 20000 219 FOOO 3020 0000000000000000 0 337 0 0000000000000000 0 00 ISO Guide 350 70 0 0 206 0 0 0000000000000000 U s 0 0 33700 usd 0 206 000000000000 0 387 0 0000 217 01 0000000000 000 No 7 00000000 004 42323488 42667254 42495371 0 57 007 42309712 42379492 42344602 0 12 037 42829975 43064572 42947274 0 39 049 42362012 42810796 42586404 0 75 055 42443628 42501191 42472410 0 10 100 42374569 42457870 42416220 0 14 112 42384326 42595641 42489984 0 35 121 42293310 42629226 42461268 0 56 142 42687809 42993152 42840481 0 50 148 42307969 42531919 42419944 0 37 42547396 0 55 02 00000000000 P 0000 6819E 11 9 7 577E 10 2 19 0 118 3 02 3 453 11 10 3 453E 10 1 027E 12 19 00000 2 OU
168. 000000 2 000 200 08 20000600 2 0 WHO LXOO 2 WHO 00000 2 0 00000000 2000000000000 2 5 B 2M U 000000 00000 2M 2M0 000000 862000 tl uu Bmc 00 000 BMG OO X1 00 E d OOTOSOHGI UBMGJ 000000 EQ 00 OBMG4 000000 000000000 dae 2 0 0000 0000 20000000 51 00000 BMG BMG 10 00000 00000 B2M N 2M B 2 00000 00000 398 SIS THE fale Ppa ete pa sae 1m 19 su Ero run a bot HER E Cr Er rin ET EI ET gt jm a SE WO res CHEER ie L a a Ep dA
169. BE B ra 03 1900000000 D uuu O_O n O500000 mL moooFcocool p4bEmuauuurmududuumau cn 5550505902 005 8 E J Ot UHH 135 0000 COOOO0 U ArdbeA o O U U
170. 07002656 0 424 425 UU 19000000 200 5 1310 D HD U U 20F FAX 044 520 5177 1 FAX 044 861 4100 426
171. 15 15 15 15 z 10 z 10 z 10 z 10 P mi m d oOo E r3 o 5 5 5 5 y 0 798 x 0 078 y 71 45 x 0486 y 0 987 x 0 531 y 0 893 x 0026 0 0 0 0 0 5 10 15 0 5 10 15 5 10 15 5 10 15 000 Dng mtr Ong mtr Dng mtr mit 15 15 15 15 eooo000 el nu 9 9 10 10 z 10 z 10 P Oo E EX Ex r3 tx Ex t 3 o 5 5 5 y 1 009 x 0 133 y 1 067 x 0 134 0810210266 y 0 974 40 017 0 0 0 0 0 5 10 15 0 5 10 15 5 10 15 5 10 15 Dng mg ig mg O O O Ong nitri mg 0 798 1 145 0 987 0 893 1 009 1 067 1 081 0 974 1000 1 000 0 798 1 145 71 0 078 0 486 0 531 0 026 0 133 0 134 0 266 0 017 0 486 0 531 UHHH 000000 OU
172. D uuu 10 w w 1 5 5 OOOUOOUNISTSRM 92100O000000000000000000 0 0 E EISE E ES CES Oo Lr L1 Lr LE E 5 0 0 0 0 0 OU OU OU Foonoond y rd ESE EIU G Co O 00 00 OU OU OU 0 0 0 0 EX LE E CE LI EE D uuu 0 0 0 0 0
173. 2007 U O O 2005 12006 NCCLS 27 DUUIDDUDDDUDDUDUDUDDUDUDBDDDUDUDUDUDUDUDUDUDUDUDUDUDUDUDUDUU uDULU UH 00000 UHH TG 200 50 100 0L HL DU D D U DU E 50 mpg 0 5m 0 00 70 C 20000000 0 20 C 70 UHH 0000 HDL C LDL COOUUU 60000000000000000000000000000 10 85 ASTU ALTU UA TPO ALB T Bill I B D D A 66 nm J 000 60000 3 200004000
174. 00000 86 310 313 2007 2 Jeppsson JO et Approved IFCC reference method for the measurement of HbA1c in Human blood Clin Chem Lab Med 2002 40 78 89 3 Passing Bablok W J Clin Chem Clin Biochem 1984 22 431 445 4 0000 385000 10 7 8 2006 500000000000000 0000000000000 bAc00000000000 860 67 730 2007 6 KO50000 10 00 7 Guide to the Expression of Uncertainty in Measurement ISBN 92 67 10188 9 15 Ed ISO Geneva Switzerland 1993 35 8900050 000000 4942 1199 1204 2001 900000 000000000000000000000 000000 A1en n l U JDS Lot 20 NGSPOOOOOOOOL 456 385 388 2002 10 Tominaga M et al Committee on Standardization of Laboratory Testing Related to Diabetes Mellitus of Japan Diabetes Society Japanese standard reference material for JDS Lot 2 haemoglobin Alc comparison of Japan Diabetes Society assigned values to those obtained by the Japanese and USA domestic standardization programmes and by the International Federation of Clinical Chemistry reference laboratories Ann Clin Biochem 42 41 46 2005 11 Tominaga M et al Committee on Standardization of Laboratory Testing Related to Diabetes Mellitus of Japan
175. DU 169 1308 000000000000 950000000000 500000 5 10 00 5 5 20 000000600 DERE ROBE EO OOO eee BOO ooo ooo 09 00 0010 78900000000 007 00000000000 170 OO 8 10000000 DlUUDDUUDUDUDUUDUUDUDUUUDUDUDUUDDUD 3 2 0100
176. 00000 BXO 0000 WIBO U MWIBQ U MWIB20 U MWIBA2 TI ND25 000 0000000 OPTIPHOT2 WIBO U MWIB 0 000000000000000 00 8300000000 EE ESI 241 0 0 Ho Sp Ho 55 Ho Pe 0000000 00 0 38000000000 50 000000000 1 00 0000000000000 D 1 000000 D Dd 90000 U MNIB ue MWBA2 me MES BA520 ND25 ND25 L lI ND25 ND25 00 0 HEPASERA1Q 000000
177. A 910 0000000000000 9000000 cade UTADOOCOUOO 5000000 600 000000 00 O0000 OO 180 D uuu U2 90000 U 0000 0 0 0 00000000 00 110 0 000000 00 915 004 III 9 90000 0000000 10 O2nymQO00000 U 000000000 5 2 0 000000000 3 731 420 4 97 5 22 149 WA 00 00000 eamaTm Dt 5000000 n0 0 0 95 998 1 0001000 1 000 1 094 0 0 2 31 0 089 D uuu util BUE EE BETTE ED EPE BH 1050 i 0956 D DUDUDUD 0 998 1 0000 000 0 953 1 0351000 0 010 0 086000
178. 0 5 006 1 8 U uu 000 0 0 0 0 0 0 0 OOo 5 8 D 1700000000 8
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180. 00 Tris 6 057d 08L 0 OO 0000 8 76690 D OO 0000000 00 OPO 73000000 0 OO 00 5 10000 D 0000 950 DOOD 741 0 L0 DHJ 7 4 0 1 LHOFSHJ gt C C AB ee 0000 HFSHOOO 1 ovog 0 UD 00 318 x 4 OOO x 161 30000 0 Oooo 000 00000000 589575 000 115 83 575 ana a O03 15215 92 510 000 O04 stis 92 510 0000 Mooug 8 0000 000 0000 QMO0000000000000000000000000000000000 15 83 575000 0 00 0 0080000 000000 m nnnmn mm _ ooo ooo 1120 mMU mL 000 D sm 000 mn mwg _
181. 21 5 46 TP 08 50 a B 04 o gt d 40 4 02 o w 8 MT B HW A m O 920 920 o 40 9 60 i 20 o nun 08 001 9 02 10 08 A J CCRM 521 7 ail 9 A my dL o 10 20 30 40 50 A dL A J CCRM 521 7 mean 250 O0 mean sbD 2 11 ul uU Ll Passing Bablok D Uu 0 15mmol mol O J NIST SRM 9090000000
182. 2 28510 0 0 0 0 OO 20cm 0 0 Ooo oO D uuu 0 0 D uuu 0 0 OU D uuu
183. Dd uuiiuultl UUDDUDDDDUDUUDDUDUDDBDDBDGUDUDDUDUUDUDDUDUDUDUDBDUUDUuDUuDUUUDU DU d 000000 000o 5 5 D uuu U 1800000000 0 00 0 00000000000 306 DOOD tee tet teat hls mi t
184. III TITIT 2 00000 0000 40 6 7 20FSH 8 0000 90 11 2 BEER IH 10 109 295 00000000000 2000000000 amp WHO 21015 80552000 00000 35IU 10815 99 6200000 000 2 1890 0 2 BiosPacific catalog 12020128 Lot 97827 0 0 0 catalog No R 507 00000 1000000 0 1004 90 20000000 00000 wou DD ar 00000000000 G eq O 00
185. conmtabilityJOOO 00000000000 HDL CQ 00 LBR CI 00000 CT enter for D sease Control and Preverti on 3000000000000000000000000000000 2 5 7 4 1 2 6 2 3 1 800300 1 1 0 5 2 0 OOO0 5 0000000000000009000000 00 Reference Mterial Institute for Qi ni cal Chemistry Standards RECS 00000 0 HD L JII 220085 li n chal estero 0
186. 0 0 0 0 000 00 U u 00 UO U uuu 00 0000000 0 20060 100 00000000 20070 70 0000000000000000 900000000000 Prototypell et 126 E
187. 102 1 333 100 9 66 2 100 0 67 6 102 1 101496 102 6 43 6 101 6 101 0 165 2 101 5 CONT 1 177 101 1 107 2 101 8 106 2 100 9 107 8 102 4 100 6 184 1 101 3 183 9 101 2 101 4 102 5 319 100 0 101996 102 196 1623 101 3 162 7 101 6 162 6 101 5 162 0 101 1 162 0 101 1 OU 1380 0000000 2008 20 297 0000 O CONT 1 80 100 0 104 1 100 7 105 2 101 7 105 7 102 2 106 4 102 9 107 0 103 5 107 1 103 6 100 1 158 9 99 7 159 0 99 8 157 6 98 9 1582 99 3 1582 99 3 178 1002 182 7 100 9 182 1 100 6 1813 100 1 1817 100 3 181 3 100 1 319 100 0 32 1 100 6 32 2 100 9 32 5
188. 000 T AMYx 100 95 0 0 0000000 00000 2 00000000 0000 0000000 SAMYQ OOOO JA 1000000600 utl SAMYT D 95 30 98 3 0O 000 96 5 00000000B000000 000000000 96 19 98 6 00 974 90 00000000000 000006060 95 70 98 5 96 7 t 0000000000000 96 70 98 4 1 97 4 0 0000 4 154 40 162 0 U L 154 20 161 2 ULD 0 1 1 D 96 5 96 7 974 00000 5 000000000000 e 4050 1012 JCI ERM Lot 0050 00 UH 0000000 146 0 OU
189. 0000012000000000 13000600 1 0000000 WED 000000000 OOO 4 000000 2 i 20 81 960 4 4 000000 15 19 1000000000 FTA ng dl 0 0 8 2 1 1 5 4 1 512 4 dn 4 2 2 5 500 INDOOOOUOO 2000
190. Swiss Prot http www expasy org accession 027418 0800000060 uj 18 U 36 0 53 0 0000000000 OTDMSRKAFVFPKESDTSYVSLKAPLTKPLKAFTVCLHFYTELSSTRGYSIFSYATKRODNE LIFWSKDIGYSFIVGGSEILFEVPEVTVAPVHICTSWESASGIVEFWVDGKPRVRKSLKKG YTVGAEASIILGOEODSFGGNFEGSOSLVGDIGNVNMWDFVLSPDEINTIYLGGPFSPNVLN WRALKYEVQGEVFTKPOLWP D Uu uuu 000 D 20 U U Polymer Laboratory
191. o ogo E D uuu 348 90000000000 344 LLL D OU H u Hu ReCCS L D LC MS Manufacturer Manufacturer LE B d a OD U0 000 0000000 D D amp DD UU Hu 00 000 ReCCS OD LC MS 20000600 5 000 5 D 0000 Manufacturer 00 Manufacturer OO 000 0000000 amp 1 LI LE B d ada OO00M0000 End user uui 90000000
192. 1 280 0 000000 285100 0 0 0 34 50 0000000000000 0000000000 000000 OO KGI 0000000000000 00000000000000000000000 12 oO oO E 1200000000 910600 OU 013000 COO O O O CRP 18 F OO t L1 L1 L1 L1 L1 L1 L1 L1 L1 L1 L1 L1 L1 L1 L1 L1
193. 0 0 OOOO000000 0th moo as BH E EF E r3 am LJ I m gt Boo i 0000000000000000 00 ooo oon ooo ooo ooo on on U No 1 90 IU m 2 2 1 0 3 5 OO 4 20 D 0 5 50 0 0 6 100 0 0 7 200 8 002 o0 9 2 1 l 10 5 0 11 20 0 0 12 50 o0 13 100 0 0 14 200 15 3 16 2 D 0 17 5 0 0 18 20 19 50 0 0 20 100 21 200 22 O04 OQNUIU m 0 0 23 2 0 0 24 5 0 0 25 20 0 0 26 50 27 100 0 0 28 200 No 29 000 1 30 2
194. 0 0 0 0 220000 0 270000 Ud 900000 100010 000000000000 Ud 900000 0 993 1 000100 0 873 O 1 2520 00 0 538 0 4240 000000 0 9 11G0000 00000 0812000 0997 1 0 0 937 1 1480 0 0 0 30010 11 9 1 8 112 3
195. 339 2 17 6ng L nean 15D 500000000 05 0000 0000 OU DU U p320 1992 200 00000 00000 00000 00000 UDDBDDDDUDUDUDUDDUDUGUUDUuDDUBUDUuDUUu BUDUU 0000000000 000 20010 440 40 467 472 3 0000 2002 43 1 1 19 131 4000 200400 JCCISUUUUUUUUUU UU U U p9 2004 5 Itoh Y Ichihara Kanno T Sugawara T Ohkubo A Hirabayashi Y Igarashi S Kawano Iwata S Saito Kawai T Serum protein standardization projec
196. 8 87 0 32 mol L 21 50 0 48 U mol L 20 120 000000 100 20 q 0 20000000000 0 0 0 0 0 0 0 0 0 0 OU OU DU 18 1 5 D uuu 020000000000000 OO00000 2007 9 13 37 0000000 2008 1 10 000000000 50 30u 5 07 mol L 00000 15 30 u mol L UD 1 022 1 025 g cm 25 D 0
197. lu 020000 T4000 359 3
198. 9000000000 000000 D D 0000000 Sm0 000 SSAQOOO SS BIJU I I Scl 70 0000 Jol OQ 000 CENP BOQOO dsDNAQ OOO 55 0 LB Ud 90000 5000000000000 0000000000000 4000000 100000000000 000000000000 000000000 UU OU 200000000 0 U 0 1 0 00000000000 U 90000 0 0
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201. WG 000000 ANA RF O E2 06 C8 C9 BO 0 0 0 1110000 1830000000000 0000000000000000 E20 FSHQ LHO OU 236 HEPASERA1Q 000000000000
202. OO 8000000 30 D uut 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 325 1951 0 113 3 2305 0 2204 0 00000 16 99 7 109 026 80000000000000 80 00000000000 180000 18000 190 000000000000600 0 00B 2000 1500 1000 00 190 0000 500 y 1 026x 7 202 R 0 998 0 1000 1500 0 500 oo 180 0000 2000 0 OOF 2000 1500 1000 00 900000 500 f y 1 095x 17 760 R 0 995 0 500 1000 1500 180 0000 2000 00 10 0000 2500 2000 1500 1000 500 r y 0 944x 5 795 R 1 000 500 1000 1500 2000 2500 oo 180 0000 OO 000000600 1800000 1900000000000 0000000 1900000 QIDLGNMS D D OU D 001800 001900
203. 0 2007 J 2006000 0 0 0000 U U 0 D ASTI ALTI LDH TPO ALBO ZTT 717000000 D Uu 10000 00000000 2mLoO 000000 100 00 000000000000 256 100000000000 20m0 000000 15 00 0 5 OO 40 QVO00000000 298000000000000 40000000 00 72000 00 2 UU 0000000000 0000 50 0000000000000
204. 10 140 190 21 287 OOO 0 00000000 WHO2ndIS 80 552 0 0 ONIBSC 80 5529 CO0 0 00 0000000 0000000 amp wHO2ndIS 80 55210 0000 m 0 0000 OOOOO0g000000g000 000000 0 0 015 0 O 5 0 5 00 NIBSC 80 5521 DOO 0 au 0000000 00000 000 L C u n uut WHO2nd IS 80 55211 O WHO2nd IS 80 552 e p 15080 55200 0000 0000000000000 000000000 00 00000 Du 1 0 1 00 0 030 0 O21 0 081 0 041 9 00 288 000 0000000 00000000 n pool roa m zs S mS e esa 2 A i 1 8 a gt amp a m m 11 m IR A eds B te e e mio g IN PO COS ep bu o repe iE e E nd od ba
205. 0 900 1 10 00000 0 0 0 0 90000000000 000 LE B CTI DI C U Mo tp a giu er uaa 000000 f LH Baum t Manufacturer 0 000 Manufacturer LE 0 0 DTI op 00000 0000000 Imm End user amp D 90000000
206. 15 6 IU mL D D LU RF O 0000 WHOstd ROC MC Il 190 190 2B 1155 50 50 3 y 1200 0 170 4F 96 100 5C 83 150 C 130 ol _ ju 840 130 120 90000 9 00000000000000000000000000 RADUDUD 265 10 500 00000000 0 100 0000000 157 146 138 103 82 77 65 57 40 22 18 O 11100000 U 4 266 2 ura S er r os me 31 811 1109 1573 so 739 458 535 323 214 20 274 243 177 94 69 000 20
207. m jJ o REIR s es uu CCRM 224 2 HDL C 603 09 my d UU 619 620 621 5 ___ UU UU 0 EQAU DU Uu uut UU p C C LDL C my dl 1309 1304 1286 1291 1292 1310 1300 130 8 1306 1317 1319 6 6 6 6 6 6 OO rg 130 80 128 97 13140 DIT J CCRM 224 2 LITE D ReCCS NIST SRM 195101 coco LDL C 11323 31 my d 110 19 1162 my dL ReCCS n 250 DEC 1118 12my d 110 6 1130 1 10000000 000000000000000 0000000000 72 5 5 7 4 1 2 670 2 3 1 810 30 0 0 1 1 0 5 2 0A 5 00 0000000000000
208. 1 00000 1800000000000000 18000000 UH 0000 UHH uuu OO 18 80 00 20 000000000 UHH uuu 80 q 20 700000 1 D uuu 0 0 00200000 20 00000000000000 0000600 20 QU 000 500000 20 000000000000000000600 0000 20 1 3 0 000000 182 OO 700000000 2007 8 170 LI CONT 1 80 C D 1009 00000 Eis RE hf BN Ga GU ERE EIL 100 4 101 1 48 59 100 15 98 6 1014 49 03 100 15 99 5 101 4 48 81 99 82 99 1 101 0 183 OO 2007 8 17D 0000 CONT 1 80 C T 100 a 000 IMM 000000000 210000600 uT TET IT T TU T GE 184 8 2008 20 90000 CONT 1 80 C O T 100 00000 0000
209. 821 9110 90 81 8377 821 8348 8634 89 35 77 30 60 72 82 77 114 60 72 9110 109 Tir LOL 100 103 105 108 093 074 Intercept 0 19 081 212 000 127 108 0 86 0 30 176 Corel 09994 0 9997 0 9953 10000 09999 0 9997 0 9993 0 9995 0 9973 LLO D DEDE OOOO NOOO D LLO D DEDE DOCOMO OO Oo DOCOMO DL O00 O00 54 2 2 00 23 OOH 006 OOF 100 100 4000060 8 20 100 100 R 0999 80 400008 09994 10918x 02467 R 20 y DDE 000 10302x 15884 y 008 20 100 ae 0002000 000 100 80 40 p s EU S 55 09989 097x 04988 m
210. WHOL O O JCTEMI Joint Committee for Traceability in Laboratory Medicine 0 0 00000000000 ibd B BHL BL B D IU 9 wt Quality management in the Clinical laboratory 0 0 0 Reference system O E 0 ll U 0 0 Japanese Committee for Clinical Laboratory Standards
211. 000 DUDDA 00 00 000000000000 0 00 0 0 000000000000600 0000000 00 83 143 00 sp cu ng dL ng dL 74 112 017 16 134 074 17 543 326 000 00000000 62 00000 T 076 051 000 ng dL FT40 ng dL 10 20 9 18 a 8 16 x n 0000 HE 1 m 0000 14 0000 6 A 0000 alf 9 ip ne DDD 5 x C ig AD 000 x 0000 m NK o 4 e 0000 08 x mc xD 000 0000 m F e0000 3 06 t x 0000 iod 0000 2 0000 04 0 000 1 00000 02 0000 u 0000 nang o 0000 00 00 05 10 15 20 376 10 0 0 0 apad 0000000 00
212. 100000000000 29 15 00 08mLOOO000000 OO 40 QVO00000000 D Uu 1 100 150000000 000000000000000000 1000 5000000 50000000000 000 0000000000 00000 28000000 000 720 00000 1000000000 8000000000000000000000000000 0000000 000000 00000000000 00000 257
213. WHO Q 15 0 269 500000 10000000000 11 0027 0000 5 0000 15 0 00000000000000 a 0000000000000 b o9 000000 TPALBZTTAGO000000000
214. 0 20 20000 4000000 6000000000000 0000000000000 000000000000 00000 5000600 30000000 0000000000000000 70 Qo000000000000000 40 lt 15 10 c 596 _ L3 0 000 E E 92 XY 0 E Ez nm H eh stil 06 000000 LDL C 2 6 20 NCCLS 5 0 6 U 0 130
215. 000 000000 51 0000000000 00000074200 0451 10 00 00000000 00 0000000000 0000000 HECTEF PS1 0 000000 000 0 000000000000 40 00000 000000000000 0 CDD 00000 Pool 200000 Sinde 0 2000 000000 00000000000 0000 00000000000 5000000 gevan 00000 D B pa dd aseneva 0000 00 0000 000 00 000 00 0 10 LC MSO 0 00 0000000000 00000 0000000000000 CVO 0 141 350 130 390 00 000 0000000 000000 UCVU 0 0 220 00000 ea Eig oo Id ng a ie ssp id m tas D 2 512 452 452 243 240 257 228 317 291 301 276 315 oo 00 3 ASE 3 78 ner 553 354 365 4 444 amj E 518 4 Cri 078 045 062 045 090 062 72 077 050 5 cre 259 iej 380 222 247 30 252 4 273 e trsi eas 885 524 59 ase 395 150 ave amf aoa 6 ee e os mper os omi ow om Pe ca ass zm 294 237 328 e Ls o o o 015 008 225 10 8802 sax o4 osi 65 roi os 036 oed 12 156 i 15 12
216. 59 07 60 94 60 64 59 43 6222 5583 5758 6428 5751 59 72 44 5583 64 28 35 52 25 10 2434 2625 2359 2642 2513 2424 2593 2137 2471 42 2359 2642 3 562 1871 15 71 1757 1445 16 73 16 34 15 66 1588 1467 16 19 81 1445 1871 37 7 2 62 83 6622 6592 6559 6963 6286 6419 7125 6042 6543 46 6283 7125 38 82 5447 5638 6101 5481 5786 5376 5337 5843 4975 5554 48 5337 6101 39 92 3 4199 4122 3907 37 66 3855 3465 3577 42 16 33 24 38 26 73 3465 4216 40 102 180 15 34 14 59 1396 1291 1302 1322 1176 1361 1210 1339 82 1176 1534 Al 11 2 2409 2791 26 13 26 20 23 59 26 05 24 56 23 24 25 29 20 95 24 88 62 23 24 2791 57
217. Buf r base MENS ine Manufacturer End user HECTEF SRC Manufacturer nnnn nnnn UH 0000000 UH 000000 WON BSC 66 306 7 0 000000000000 000000000000000000 51 D Uu 9 52 1 B nuc 000 DHE OOF 006 1 H EOS IMP 0o00 foo tooo
218. E B po ooo a E ooo as oo Foo i oo eno Re ooo S U i ooo oo ooo m oo ooo ooo oo oo a S oo ooo E bo ooo ak 8 8 5 oo ooo 3583 8 8 8 unm R RAR 8 8 R B ooo po ooo m o E po ooo a ooo a 5 S ooo 8 E co oo ooo n E i i E oo 98 5 i cu a E 2 po ooo _ po aa po ooo E oo aa 8 8 m _ oo ooo g f 7 8 8 i H oo vt B 1 a S U ooo ae oo ooo n z B po ooo op Soo E po ooo ooo E E x po ooo oo ooo n oo ooo a po ooo r3 po ooo E _ aa pa 8 3 oo ooo 8 i oo ooo 8 8 310 4 uu o uo on o0 j 0 47 0 69 1 05 0 48 45 8 131 2 02 0 50 24 7 2052 61 1579 4118 1 51 3294 2 15083 57500 0000
219. FSHO OO E L1 EJ EI L1 L1 L1 OO OOO rJ rir L1 L E L1 E L1 L1 L1 p FE LES Ed EEA REST L T LEX LE EST ES SEI ENE ea 0 0 0 0 0 0 2005 11 150 0 0 140 000 160 15 000000 2005 12 020 0 0 100 000 120 30 00000000 000000 2006 01 120 0 0 180 000 170 30 00000000 000000 2006 02 14 0 0 130 300 170 00 000000600 2006 03 230 0 130 300 170 30 00000000 000000 2006 04 25 0 U 130 300 170 80 00000000 000000 2007 09 250 0 0 140 000 180 00 00000000 000000 2007 01 160 0 0 140 000 170 80 00000000 000000 2007 02 200 0 0 180 300 160 30 00000000 302 U 100 000 2007 04 04 O 140 009 160 00 00000000 U 110 000 2008 01 259 180 800 170 00 00000000 0000 000000
220. 000 E 289 Ea E E E 258 8 mmol mol 471 13 mmol mol J U U U U U Passing Bablok mmol mol OOOOQO00000000U0000000 9509 00000000000 000 LE OU 0 0 0 0 E d EST Lupe EST E SE U 8 00000000 EUM IE JS
221. 00000 OO 0000 Boo 107 100 09737 05326 10654 07612 y 10774 14172 09816 16292 s 0991 m R 09985 50 R 09998 60 60 60 lt lm lo a a a a E B a y 10611x 19969 y 711677x 40 0605 R 09922 m R 09971 a y 6754 40 y 10025 01224 R 09967 R 09994 20 20 20 20 0 0 0 20 40 60 80 0 20 40 8 10 20 40 60 10 0 20 40 60 100 000000 00000 doo oor E x E Bl o Be Bu Bas o g OB a B B afia e 5 g E as Das 5 100 100 109 100 100 g Y 1063c 05326 y 10533x 03016 y 09101x 01896 y 10760x 07031 m R 09993 m R 09994 50 60 60 60 a o a a 10003x 07297 E ET 10522 lt 04597 40 40 20 R 05596 20 20 20 0 0 0 2 4 8 10 2 4 6 8 2 4 6 w O00 000 ODO 00 0 0 0 OOF E 85 Bs E n E 8 i Eb b a 8 gon Bs x RESO s lt E s ER S e 3 er UE ies aS P Es Su s Pa a z Beon g uunpumupnurun 42 100 100 80 eo y 10292 06751 60 60 lt 14 a a 09998 40 40 20 20 0 400000 8 2 X 20 E F E 8 B esto E Bas 100 109 100 100 100 50 y 10762x 00249 80 y 09714 06371 80 80 y 11235 09305 R 09993 R 0999 60 5
222. TPO ALBU VUAO TCI T LH OO HH DH D 000 U U HDL C LDL C 96 00 UH cbc GQU0Q0000U000 Cholesterol Reference Method Laboratory Network 0 0 0 0 OU NCCLS c 37AV 0 0000000000000 0000000000000000
223. 01000000000 00000000 00 005 T ooo Tan nnmnnn 50 0963 1389 680 1010 1457 1107 11705 17429 G x Tos 209 L3 AR VL 1164 10240 0827 1325 16 14 12 11489 15019 O x 105 L4 AR VN 1479 666 197 0 9920 0 085 0512 1187 6089 9025 O x 081 093 5 RD 1 9 0 9937 6274 i38 137 099 o 11615 16151 o o 451 344 UD DO x S28 A 10 x zx 1128 0 00 UO z 5 x x e 0 E3 500 00 250 ug o nu eo 3955 500 o D00000 000001370 3 y i E i 0 190 300 450 600 750 J sccpsoP 0 U 1 37 C 00000000 005 AKN DDD 07 000000 00000kN 167 0000 Lj 00 95 28 000 0 1 37 150 300 450 J 0 0 U 1 37 C e000 So 0000000 25 wg 000 750 O 0 0 D DU L37O uj E 08 000000 00000 0000 BEgEE 000 0 1370 150 300 450 J SCC SOPY 0 137 750 e0000 200000000 005 4 ARVL 0900000 n
224. L U U U Certified Reference Materials CRM LU EH E 0 0 0 0 U U Reference Measurement Procedure RMP 0 0 0 Reference Measurement Laboratories RML I U U U 212 DUU Cycle V 1 00000000 OO 0000 00000000 D uu 218 UH OU
225. 500 x20 1000 0 02100000 300 5000 00000 000000000 000000 000 134 ERM O U JC ERM 100050 U 5000 YO 20 0000 100 5100000600 UH di UH 0000 UH 1 50 DU uuu 0000000 AMYQ OOOO 000000000000000000 00000 SAMY D Tu88k8 IgG Tu66C7IgGQOOOU0000 MNH AMY3 AMY T I lU ll OU 71800 Assay type RATE A 0000 000 I D U UH L 000 R10 pu LO 000 000 R20 pu LO OU mmu JSCC 5
226. 8 0 00 1 008 0 965 0 962 62 35 67 52 75 44 0 998 0 996 0 998 1 018 0 974 0 972 82 31 86 56 93 40 0 997 0 995 0 998 0 956 0 953 u 8 39 16 91 0 997 0 998 1 021 0 979 0 972 36 15 N 42 10 54 89 0 996 0 997 0 996 1 011 0 978 0 968 0 965 35 82 13 15 41 97 49 70 0 999 0 995 0 997 0 999 1 013 0 968 0 967 18 93 27 08 33 72 0 999 0 995 0 998 0 992 11 90 0 996 0 950 25 63 0 998 0 975 35 56 11 52 0 999 0 999 0 970 1 018 79 67 59 51 0 997 0 996 00008 1 200 0000 1 2 3 1 048 0 950 338 e 000 e 00000 v x e e 00000 v x e 000 e 00000 v x 3000 3000 3000 2000 T 2000 T 2000 8 2 E m o E 1000 1000 C3 1000 e 0 0 0 0 1000 2000 3000 0 1000 2000 3000 0 1000 2000 3000 ID LC MS pg mL ID LC MS pg mL ID LC MS pg mL e 000 e DDDDD v x e 000 e 00000 y x 000 3000 3000 3000 2000 2000 0 z gt 2 amp 8 a x B 5 1000 C 4000 c3 1000 0 0 0 0 1000 2000 3000 0 1000 2000 3000 0 1000 2000 3000 ID LC MS pg mL ID LC MS pg mL ID LC MS pg mL e 000 e 00000 e 00000 y x 3000 3000 3 20
227. 8 00 OO O JC ERM 174 l O00000 OU 18 DUD uu BD UuHL HL DHL BU DOG U DU OU DOS DO D DU D D UD U I 5 0000000 3400000000000 000000000000000000000 18000 00 L DU Uu Uu D 10 cin UO 00 UUDUDUDUUDUDuDU OOUOUUU0U H HB 000 U uuu O O U 00000 U uuu
228. 20000000 1000 29380 0000000 5 000000000000000 UU 2006000 2007 7000 TPO ALBO ASTO ALTO LDO GGTPQ ZTTOO0 000000 1000 00140170000000 14 7 I0 mL0 000000000000 1517 0 0000000000000000 0 0 0 0 200 258 00 L UU D 10 65 L Uu 00
229. No 20 70 140 0 AE PHEA WHO EU Te ES Bf rix 1 Cb Cn ode L P2 ou 11 12 13 14 15 17 mox Bl y a ase C w s 0000000 0 770 1 210 0000 CV 11 000000 0 9950 1 0000 0000 1 0508 0 000 CV 7 1 D 0 9950 1 000 391 0000000
230. 6 000000000 00000000 0 0 213201501100200 mir 0 00 0170000070 D DO HO D 31 H0 D D DO 0000 00 0000000000000 000000000000000 00000 00 00000000000000000000 0 000 0000000000000 wooo 0000000 317 EH ERES E HT p RED TR NN 2007 418 18 000 D 30 000 0 0
231. 236 UHH 0 236 A R 1 1 238 09 09 000000 ANA 238 OHHH 000000 RP 253 OHHH 00000000 Lm 272 OHHH 00000000 SH 301 UHHH 000000000 322 UHHH 000600 347 UHHH 000000600 384 U H 409 420 000 424 2006000 In Vitro Diagno
232. 157 146 138 103 82 77 65 57 40 22 18 110000 6 268 LO d 7 ae O k EE a 5i 2 S J T Jl 3 L 8 HL 8 19 15 38 L gt 8154 591 885 8818538 77885718812 35 LH 2 15 57 1000 0000000000 293800000000 500000000000 0000 148 IU mL 143 IU mLOQOOUODRAQO 72000000 15 6 14 9 0 0 0
233. OU OU OU ESI ES fo EY Lu EJ Fay Pr EY ES LI i 0 0 0 0 0 0 0 0 0 LOO OD O ang 0 0 0 0 0 1000 0 0 0 0 0 12000000000000000 200000 000000000 400 OU 6 60 0 00047 x 100 0047 0 00000000 OU 0 0 5 18 50 000000000 0 047 38 Uts 0 047 36 month 1 702 08000 218 1 002 1000 9 0998 0 996 0994 0992 0990 0 988 Relative Area 0 5 10 15 20 Time month 03 000000000000 03 0000000000 Month Relative Area 0 1 000 3 0 998 12 0 990 19 0 992 0 995 04 F D 0l 1 4 97809 05 5E 05 6 605 0 124 2 1 50743E 05 7 5 06 8 6 48552E 05 t 95 96 95 96 D ll 0 9991 0 00207 481 554 4 31E 06 0 990 1 008 X 1 0 00047 0 00018 2 570 0 124 0 001 0 000
234. 0000000000000 00000 000000000 0 15 mmoVdLQ U 000000 0 15 ngLT lU I UU OOO 15mLQO00000000 70 9000000 Dgrereiriijppn u nggpna aggupnugnpnupaoupnuug upngagupngpnpanpnau 5 202 8 19000 180 00000000000000000000000000000 000000
235. RM J 1 EE Ea ea a aE ELE EJ ES ETE EET 1 0 0 18000 L1 E 14 0 0 0 0 0 998 1 0000 r 998 1 0000 0 CRYO J C ERMQ Lot 0 56 JC ERM000000000000000000 13 0000000000
236. 000 ReGSOOd 0 0 0 0 0 0 E uE ESTE EINE EHED EJ SE EEE Exp ES YE TEI PEST EE EJ E L1 eo 358 90000000 00000000 4
237. DU Uu 000000000 2 10 100 0000 OU 210 00 IVF DO 9D D D 12 1 ewangnggggpnpagpnan 4 40 00 0000000 2 5 20 50 100 200 mIU mL0 D punwBHonn un D Uu NIBSC IS 83 5750 000000 NIBSC IS 83 5750 000000 OOOUOU FSHOOOO 000 NIBSC 1st IS 92 5100 00000000 DU uuu DUD NIBSC ist IS 92 5100 00000000 0 0 680 1 38000 808 1 0003 00000 0990000000
238. noe m tink oo ONNAN eh AAA 3520000000 U 0000000 36000 5 110 3 35 yd0 0000 00 0000000000 0000000 00 000000 uU uu uu 000 0000 gd UD 0 71 0 80 3 34 006 ABO O B03 0 80 0 81 3 03 0 05 ABBO 0 45 0 57 3 30 0 05 oo Ba 0 81 1 01 3 01 0 05 BG 0 50 0 64 3 13 0 06 OO 0000000000 H 328 0 07 gd OOU 000009d OU ABO O 3 31 0 06 OU EG 3 05 0 05 OU 000000 AB BQ 3 21 0 05 OU HAD OO 0 BQ 3 01 0 05 OU FR BOG 3 11 0 06 110 OOOO U utt 0000
239. UHHH 000000000 IRM
240. n8 OR g A 09 gj ig Z L3 C L3 C E mo dio en x oig DD 0 9 MIL il ik a Hd a5 Et o o FTN o ol E c E E I OdsSon E U 3 0000 NaosPHDUDUDUDU 113 94 919 1086 74 732 57 569 5 1 487 T Udson 33 OO IFCC JOSO 00 000 00 000 JOSO m I Joso 000000000 IFCC nol B 0 D D Bd B D ODD DIFCC 0 5 J DS 0 0963 IFCC mol 1 62 O 3 00000 000000 001995 00000 000 05 Lot 10000 00 00 D 05 Lot 200000000 00005 0 030 000 0 00 000000 000 000 05 000 00 000000000 00000 000000000000 00 00 00 o OO 00 IFCCI J D a d p an Kosoon QO an d 0000000000 OOOO 00 HPLCD 00000 30 HeA1e 00000000 005080 m d Dan OO IFCCIU 00000 e 00000000000 IFCC Orme 30 D 0 000 0 JOSO D d d Josi DOO bi HIH lI
241. 0 5 H ee Selected reaction Monitoring LC MS MS Thermoelectron TSQ Quantum Discovery MAX 0 0 Imtakt CadenzaC 18 2 0 mm i d x 25cm 3 u mg 0 000000 40 c U 000000 401 00000 0 0 0 0 0 0 0 0 0000000600 0 5 min B 30 5 15 min B30 gt 40 15 20 min B40 gt 100 96 20 30 min B 10096 U UUUUU U U U m z 363 121 eortisol m z 367 121 d4 cortisol UU SRM909b 0 O00 1 02955 gmL Table 2 FigJ Tabe1 ng g 0000 ng g CO 1 ID LC MS MS 1 253 0 060 CO 2 ID LC MS MS 8 34 0 50 CO 3 ID GC MS 28 18 0 62 CO 4 ID GC MS 52 47 1 15 CO 5 ID GC MS 151 1 3 3 82 Table2 h g dL ID MS AQ Bg DO CO 1 0129 0 29 0 31 0 01
242. 27 0 0000 000 00 000000000 kos00g 00000000 HPLCO 00 00 000000 0000 0000000 0000 0000000 00 00 9000000000000 000000 00000 0000 00 000000000 15 m o T A 99 y 0622 109x 0 5 10 5 0000 Wn y 041841 105x 0000 0 5 10 15 KO500 99 1 99 HbAlc 99 02 9 04 06 08 02 04 06 08 08 r 06 f 04 f 02 r 0 zy 08 r 06r 04 IN ds 5 10 15 KO500 99 5 O00 0000 00 250 H 250 02 O00 A 0000 0 nmean 2SD 0 250 OO HbA 00000000000 OUADA EASD IFCC IDF 00 HbAICO 0 0000000 0 0000000000 000000 2007 0 600000000000 Arerican Diabetes 0 OOO 00000 European Association for the Study of Diabetes EASD TILI O O U U O 0 0 International Federation of Clinica Chemistry and Laboratory Medicine IFCC O U U O international Diabetes Federation IDF 000 0000 0000 0000 e 28 1
243. E ES 0 0 0 0 0 0 TERI 280 5a pregnane 17 21 diol 3 11 20 trione 5a dihydrocortisone bB pregnane 17 21 diol 3 11 20 trione 58 dihydrocortisone 0 4 pregnene 17 20a 21 triol 3 11 dione 20a dihydrocortisone 17 208 21 trihydroxypregn 4 ene 3 11 dione 208 dihydrocortisone mall 12 8 pPO berum ps mz 36380 0000 202 3610 0000 LOMSMSQ DD D U U 0222361 E ES L ES EM EIL EJ OO00000 U Thermoelectron 000000 MS MS TSQ Quantum Discovery Max 0 UU U LCII 0 Agilent O0 110000 0000000000000000000000
244. 000000 00000 00000 00 5 00 e 0000000 HbAlc 250 110 250 350350 49150 601701 80010000 0 Un U O HbOQ 140 10 YL HbF lt 10 MetHb 0000000000 lt 0 50 29 OO 0000000 e 0000 231 35 mol mol 0 200m 0 0 0000 000 D 0350 400 00 0100 mi D DO OD U 350 441541 600700 80 mol OOO 0 100 mmol mol 80 qyg odd UD IFCC mmol mol T UU U U U U IFCC HbA1cI OOOO IFCC H DB HE D O CE IK UO U OE EE CL 1 Iml mol 00 IFCC HbAIcQ 30 3 08 000 2 37 9 07 000 3 55 8 11 000 4 78 5 13 000 5 103 7 17 5 IFCC
245. 19 45 2180 2193 1863 195 1864 1945 2062 1822 1255 1985 73 1822 2193 3 N3 3790 4210 4376 35 89 378 37 29 37 90 3951 35 28 24 62 38 69 7 6 3528 4376 4 N4 6070 63 20 67 28 5287 594 59 32 60 70 6152 5373 4050 5975 79 5287 6728 5 IN 5 86 34 91 10 90 81 83 77 82 1 83 48 86 34 89 35 77 30 60 72 85 53 56 77 30 91 10 104 105 096 095 097 100 103 089 0 70 Intercept 132 2 00 114 105 0 20 0 00 0 24 0 67 104 Correl 0 9995 0 9987 09968 0 9997 0 9999 1 0000 0 9998 0 9997 0 9989 oo giri 653 6 00 114 648 6 89 7 27 703 656 8 70 6 74 62 6 00 127 1945 1973 1899 20 66 1945 1934 1945 1985 1980 19 35 19 66 25 18 99 20 66 3790 3929 39 80 38 70 38 75 38 48 37 90 38 26 3904 36 53 38 78 15 37 90 3980 60 70 59 61 62 22 56 44 6152 6108 60 70 59 70 5984 59 15 60 14 29 56 44 62 22 86 34 86 49 84 65 88 73 85 46 85 88 86 34 86 81 86 42 87 94 86 35 14 84 65 8873 No 1 nil nil nil nu nu OOD nul nu CV Min Max TI nuummum umullilii 407 2 87 259 5 05 353 403 407 3 3 374 478 370 205 259 505 12 163 181 032 288 0 58 165 163 125 0 45 2 82 1 24 79 7 032 288 13 392 384 183 503 3 82 392 342 3 15 474 351 25 9 183 5 03 14 505 470 3 24 5 89 459 5 29 5 05 467 455 5 64 4 75 160 3 24 5 89 15 147 152 054 2 4 0 37 146 147 123 0 29 2 5 1 07 93 9 054 2 74 16 622 5 67 3 76 6 73 469 6 07 622 5 61 489 648 545 176 3 76 673 17 372 287 183 447 3 11 405 372 350 298
246. 300000 unu OOOO 0 0 Spo Hog Peg O Hog Spo Hon Pel O 50 0 0 50 0 0 D 00000 3000 000000 HEPASERA 10000000 40 00000000000 OO HEPASERA1 R40 R50 000000 0 p lt 0 050 0 0000 5 5000000000000 5 Ho 000 1 0 0 000000000000000000000000000000 244
247. La 0 IMSO 58500 OU OU OU 229 UHH 00000 0 0 0 0 0 0 0 EL E EN ES 256732 E S E E E Gea E ET EDS oad EST eS ES GEI ESL ES E E E Eel E
248. Lot 8 4 ERM I JU I IJJ 0 JSCC JCCLS 142 Ea 2000 LOO 50 DIET i p ppp Been cursos 155 085 Sean 11621090 mg OSS 115 IMS 03r OTT ETT TST c o inoa WSCC TT 4 1670 067 439 0993 005 1 01 1674 048 029 O 1591 1758 O O 091 073 3 GalG2 CNP__ 1607 194 439 0981 064 110 1823 2154 1182 x 1672 1974 x x 110 081 4 GalG2 CNP 1405 108 439 0985 0891 1 01 168 7 28 22 1673 x 1565 1810 x x 087 064 5 GalG2 CNP 1469 198 439 0986 020 106 1761 2923 16 60 x 1637 1886 x x 126 096 6 GalG4 CNP 1766 129 439 0992 165 109 1791 253 141 O 1695 1887 O O 110 089 7 BGS PNP 2234 114 439 0994 054 134 2226 083 037 O 1212612326 O O 129 114 8 BG5 PNP__ 1688 083 439 0 992 046 101 1673 152 091 O 1585 1 60 O O 074 061 9 BGS PNP 1715 135 439 0991 241 1 04 1694 211 124 O 1599 1788 O O 123 100 10B
249. g dL 00000000000 Emu UU U 2 3 003 3 012 3 027 000 3 014 3 001 3 044 CV 0 54 0 47 9 3 010 3 016 3 031 3 045 es 3 019 3 016 CV 0 50 041 060 000 3 026 3 021 3 031 105 CV 0 36 3 022 3 047 3 047 3 027 59 596 0000000 A A 90000000 190000000000 00 oH ooo m ooo E m EL gt EHE mnm see SS 4 m fees a EJ GOA EEE m lt m 0002 OO qud 2000 g m noo Exe moomoo Hugo Epp wl go r3 m f E ioe o ono0op20 m a Aog o ELE Se noo o ooo is ELE E Oo E N E oo co ngu o Ad
250. 00 UUDUDUDUU 000 00 D uuu Du 00 D uuu Uu OOUOUUU0U ul DU uuu O O U Uu OU OOUOUUU0U D uuu 000 D uuu 00 U uuu 00 00 D uuu Du 00 D uuu 00 D uuu OU DU uuu 000 0000000000000 D uuu Uu OU DUHH OO U O U U uuu 00 OU 29 10 000 2005 11 079 180 30 0 20 000 2005 12 079 31 0 30000 2006 01 170 0 0 130 000 150 00 00000 32 0 40000 2006 03 109 0 0 130 000 150 00 00000 33 0 50000 2006 04 189 00 130 000 140 14 34 0 60000 2006 08 029 0 0 130 000 18000 00000 35 D 70000 2006 09 26 0 0 180 000 150 10 000 150 00 00000 00 180 00 00000 E E E LE EI EJ EX EF E 254 36 37 38 39 40 41 42 80000 2006 12 22 150 000 17700 90000 2007 04 259 O 0 130 000 150 10
251. 0O00000000000000000 70000000 00000000000000 5000 LU 0000000000000 RE J 151 1 RADON RF 100107 500 20901077 50000000 1400 C D FG H L J M N P QO0 0000000000 60 50 00000000000 080000000000 1000000000000 00000000000 15 000 g 190 000000000000 0 3 00000 g0 40 000000 6 Anderson SG Bentzon MW Houba V et al International Reference Preparation of rheumatoid arthritis serum Bull WHO 42 311 318 1970 200000 36 6 819 829 1996 1600 U 0000 0 29 320 00 170 D 200500 30 270 1600 000000 2 OU 1700 20050 0 30 i000 540 80 853 860p 2006 271 UHHH 0000000 LHO OU
252. D uuu 000 D uuu UO D uuu UO 2005 11 89 0 0 130 000 170 30 00000000 348 e 2005 12 50 00 1380 000 17000 00000000 e 2006 1 230 U U 130 000 15000 00000000 e 2006 8 210 00 150 000 17000 00000000 000000 2006 12 27 0 O 130 000 150 00 00000000 000000 2007 2 140 0 0 180 000 150 00 00000000 2007 5 239 0 O 150 009 170 00 O T CAT 2F A 00 000000 2007 6 270 0 0 150 000 17700 00000000 000000 2008 2 219 00 150 000 17000 00000000 90000000000 OOOO 18000000 19000
253. 03 OO 0000 WGCCRM 224 2 UUIDDDUDDDUDUDUDDUDUDUDBDDBDGDUDDUDUDUDUDDDUDUDUDDBDUDUUDUDUUUDU 300003 20 00000000000 J OPM 224 20 D D Harr secgogodgd 300 3000000000000000000000 2000000000000 J CRM 224 21 209 NST SR413951 OO ammi axpnaupnapnaau 4 8 POUT OO EO OO pooonooo B c
254. 5 0 1 1 1 E3 E 0 05 E3 1 0 1 00000 UH 0000 UHH 0000 8 001 OO0O0000000 Liuichek Level 19 Level 20 U 5 000 1900000000000 0000000000000000000 180000000000 0000 18000000 OU U Amylase 100 U L 300 U L 600 U L OUOOUUUU 2500000 UHH 0000 UHH 0000 190 20 0 18 0 16 0 14 0 E 120 10 0 80 60 40 20 00 000 JCCLS CRM 001a 191 Lr
255. 0 0 U uu lUDDUUUDUUDUDUUUUUD Uu 00 UU 00 DBBBUBUDDDUD 00 ee 00 000000000 00 DBBBUBDDOUDU 00 3000000 20 0000 190 60 240000 000000000000 0000000 000 UU 3 0 158 002 OOO PAW LipseQGOOOOOO0O0U000000 10 OOOO 190 60 2440000 10 00 12 00 20 8 10 0 00000000 1000000 D D 0 2 1
256. 18000 NIBSC code68 40 WHO1st IRP UD NIBSC code80 552 WHO2nd IS UD wHO2nd ISO 80 5520 0000000000000000 D WHO1st IRPO 68 400 0000000000000 90000000 U 180000000 190000000000 00000000000000000000 CLS 0 nm 0 0 iJccrspgnununuug 00000000000000000000000 2006000 100 Se 4000000000000 D uu NIBSC 2nd IS 80 5529 000000 OOUU0U 274 NIBSC 2nd IS 80 5529 000000 UUDUDUULHIJIIDU L 000 NIBSC ist IS 96 6020 00000000 OOUU0U NIBSC ist IS 96 6020 00000000 000000000 2
257. 3 3 0000 100000 uuu 2 8000000 00000000005000000000000000000000000000000 UUUUUU UU 3000 rpml 50 400000 500 5000000000 4000000000000000 O 20000000 2 171 OO 9 10000000 DlUDDUUDUDUUDUUDUDUUUDUDUDUUDUDUD 110 000000000000 20 10 00060 20000000000 OWO 000000000000000000000 0000 100
258. 5 5 0 3000 000000000000 O manufacturer s working calibrator 17 0000 2001 2002 6 O J CIPM International Committee of Weights and Measures 00000000
259. oe e m HECTEF C1 HECTEF PS1 3 HECTEF PS1 CAL x CAL CAL x BI CAL Pool e Pool O singel Singe O ag E T le Men 0 2 g lt ees Pool D 0 2 4 6 8 0000 0000 371 D ng d 10733 00406 R 0 9955 1 0605x R 209953 D Uu 2 HECTEF AS1 HECTEF C1 HECTEF PS1 CAL CAL Pool Singe Pool 0 00 Poon D 8 FT40 ng dl 213263x 0 0761 R 0 9886 y 1 3023x R 0 9882 FT40 ng d 10084 02257 0 9957 09372 R 209883 HECTEF AS1 HECTEF C1 HECTEF PS1 CAL BO CAL Pool O Singel Pool Pool 8 5L Syl HECTEF AS1 m HECTEF C1 A HECTEF PS1 x CAL gt x CAL e Pool O d Singa Pool D DI Pool 0 2 4 6 8 FTA ng d 8 7 6 5 HECTEF AS1 aer HECTEF C1 a HECTEF PS1 34 CAL BO CAL 2 L Sinde 0 lr Pool 0 Pool 0 0 0 2 4 6 8 372 DUU 1
260. 0000000 LW 000 0000000 LW UU 0000000 F UO 0000000 E23 Ul 0000000 Ul D uuu 0 uu OOUOUOUUUUUUOO D uuu UO 00000000N D uuu UO D uuu UO UOUUOUUUUUO D uuu UO D uuu UO 000000 2005 11 150 0 0 140 000 160 15 000000 2005 12 020 0 0 100 000 120 30 00000000 000000 2006 01 120 0 0 180 000 170 80 00000000 000000 2006 02 14 0 0 180 300 170 00 00000000 U U 2006 03 230 0 0 130 300 170 80 00000000 000000 2006 04 250 0 0 130 300 170 30 00000000 000000 2007 09 25 0 0 140 000 180 00 00000000 000000 2007 01 160 0 0 140 000 170 30 00000000 000000 2007 02 200 0 0 180 300 160 30 00000000 U 100000 2007 04 04 0 0 140 000 160 00 00000000 U 10000 2008 01 259 180 300 170 00 00000000 929 90000000000 18000000000 U RRYg 577 5780 00 00000000 000 2005 0000000000 27 00000000000000000000600 O 200508 0000000000008 00 9000 norR 500000000 5900 0000000 00
261. 10 200000000000 9000000000000000000 00000 90000000000 412 FDP 1 mL 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 1 32 31 41 31 37 26 33 17 32 25 23 18 16 13 21 28 2 24 33 37 23 27 31 24 14 23 35 21 16 13 12 18 20 3 33 36 40 32 39 39 36 25 29 37 25 23 19 19 2 28 8 29 3 0 34 29 33 32 29 21 27 28 22 31 19 20 23 29 5 45 56 50 44 47 51 48 44 48 60 36 40 33 34 37 40 6 29 29 31 29 31 32 28 19 27 28 19 3 0 16 17 20 28 7 25 29 33 26 29 31 25 17 25 31 15 15 15 14 18 23 8 25 25 28 25 29 28 23 12 22 22 13 26 09 10 14 23 9 15 25 18 24 25 24 29 30 29 36 30 30 32 37 29 42 29 33 35 29 33 33 31 22 29 34 23 25 19 20 22 29 29 30 34 29 31 3 1 29 19 27 3 1 22 26 16 17 21 28 SD 0 82 0 94 0 90 0 64 0 69 0 81 0 78 0 99 0 77 111 0 71 0 82 0 82 0 96 0 69 0 75 CV 28 3 285 257 221 209 245 252 450 266 326 309 328 432 480 314 259 mex 45 56 50 44 47 51 48 44 48 60 36 40 33 37 37 42 nin 15 25 18 23 25 24 23 12 22 22 13 15 09 10 14 20 eR 30 21 32 21 22 27 25 32 26 38 23 25 24 27 25 22 27 RANGE 18 11 23 09 14 15 13 18 10 15 11 16 23 27 15 22 dy U 3
262. 117 UHH 000 25 000 11 649 203 311 0 00 220 nM 0000000 BNOHG3CH 75 070 000 500 M 4000000000 65 1 UHH BGO 0000000000 0000 00000000000 0000000000000 GiH o Brg O3 698 20 0 0 3 nM BQ 210 140 0 0 0 0 15 M Brij 350 Pol yoxyethyl end 23 Lauryl Ether T 3 UHH 0000 ID B U D 10 BOSE 0000 2 0 nh mi 1 U utt 45 200 0000000 628 nm UHH 0000 UH 0000 UHH 0000 UHH uuu
263. 2 300 Cw 112 440000 UUDUUUUUUC 7Z1J1 7 0000000000000000000000000000 099 0 00000 00000 2 1 500000000000 00 0000000 95 0 U LU 0000 000 12 9 x x BPO 1 1 m O00 BOSD 91 x x B 15 4 O00 Beg 6 3 x x 000000 950 0 U LU 0000 000 13 0 00000 seg 1 7 O00 BOSD amp 3 x x BOS
264. IFCC J T mot OIFCC NGSP O O O 00 0000 NGSP 00 0 U UU U U U U UNGSP National Standardization Program 1 Hhalc Alc derived average glucose ADAG 0000000000 0000000000 00 00000000000 1 IFCC NGSP I ridi 0B I BH 000 00 00 00000 00000 00 0 UHbA1c ICCH DO O0 00 00000 00000000 0 0000 000000 00 00000000 000000 IFCC nol OU NGSP O O 000 00000000 00000 rcc p p O OO NGSP T T 0 0915x IFCC mmol mol 2 15 NGSP O O pmo mor n n d n D 00000000000000 IFCC HbAlc D D 000000 L3 EX CE OE E IFCC HbAIcO OOO o SOO
265. LDL C DU uuu 1 0000 1006kgL 40 000rpna 10 C 185 20 1006 kyL 000000 0 q 0000000000 1 09 0 NIST NMIJ Manufacturer End user 0 Of 0 0 0 0 0 0 0 N ST National Institute of Standards and Technol ogy 00000000000 207 SRM Standard Reference Material 911 NMJ Nati onal Metrol ogy Insti tute 0 60010 000000000 NST 5910 1 0ml 1 006 kg l 5ml D D B i D D B D D 00000 40 000rpm 10 C 18 5h IDL LDL HDL LDL C HDL C LDL C Q 00000000000000 IDL C LDL C HDL C HDL O x 1 09 1 090 0000 M000000
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340. 538 62 65 76 54 51 33 45 10590 1 60 12 4 68 1 116 81 70 66 80 72 69 62 68 1079 0 18 15 7 1275 95 85 79 74 104 71 88 79 84 99 0 11 17 9 1779 91 82 71 80 94 78 91 81 81 98 0 08 19 11 226 0 100 96 91 105 98 92 109 93 95 101 0 06 22 14 335 9 97 105 89 112 107 101 99 108 106 105 0 07 25 17 345 4 115 112 122 11896 111 118 138 114 111 112 0 08 29 21 650 3 99 109 99 106 104 104 107 111 111 103 0 04 30 22 7281 93 108 98 104 103 114 104 111 109 106 0 06 32 24 1 235 4 98 103 110 102 97 107 100 102 102 98 0 04 33 25 1 263 5 98 102 100 99 97 106 95 102 99 9496 0 04 34 26 1 219 3 98 104 110 98 102 100 101 104 102 91 0 05 36 28 2 364 3 102 96 101 99 98 100 100 96 99 101 0 02 37 29 2 428 6 100 100 94 100 102 94 99 100 98 102 0 03 O00 0000000 10 _ 0 xa b 00a ID LC MSDO O O 000 10 500 O 3000 95011 0 000 WOOO 3 2 14 130000 12
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342. 85 0 9987 0 9992 0 9993 0 9980 0 9953 1 27 0 78 1 01 0 59 0 08 0 22 0 69 919 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 OU uuu 00000 D E G H K 0000 0000 0000 0000 0000 DMU mL riU mL DMU mL OMU mL mL 18 4 D E F G H l K 8 1 01 1 01 1 07 1 07 1 14 0 66 0 95 0 86 1 08 1 000 0 184 1 79 0 97 0 75 0 43 0 90 0 14 0 05 0 03 0 81 0 9945 0 9973 D E G 1 05 1 11 1 00 0 89 1 28 1 09 0 92 0 93 1 40 1 12 0 88 0 99 1 22 1 15 0 96 0 96 0 83 1 25 0 98 0 99 0 93 0 88 1 24 1 09 0 95 0 94 0 85 00000 cv 0 25 183 177 201 6 I Sa 224 12 18 C15 200 2177 Y 209 2527 10 DDD 174 3130 4731 177 4141 5 7326 178 7340 11752 199 11728 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 FSH U 10 4 00 195 4 00 No 1653 210 1646 FSHD 0 13 41 26 74
343. Chromatography Tandem Mass Spectrometry 11th International Symposium on Biological and Environmental Reference Materials BERM 11 Tsukuba October 2007 00 Development of C reactive Protein Standard Solution PITTCON2008 New Orleans USA March 2008 Takashi Yamato Takashi Kobayashi Hisao Tsukamoto Progress Report from the Japan Association of Clinical Reagents Industries on Research and Development of Reference Material for Clinical Laboratory 11th International Symposium on Biological and Environmental Reference Materials BERM 11 Tsukuba October 2007 Hideo Misaki Development of Reference Materials and Reference Method on the Albumin Measurement 11th International Symposium on Biological and Environmental Reference Materials BERM 11 Tsukuba October 2007 422 OOO 0000000000000000 00000000000 559 749 756 2007 0 360 67 73 2007 ADAD EASD 36 310 3138 2007 u OOO 358 749 756
344. D my mg 100 3 y 1 063x 1 3564 y 0 8067x 0 386 y 12579 33787 R 0 9986 209935 R 20992 5 60 5 5 5 amp amp amp 40 E 20 0 2 4 8 0 2 4 6 80 10 2 4 6 80 10 00000 OMY mg 100 y 10367 0 198 80 R 09978 y 1 1076x 07929 y 08739 06197 R 0995 E ol R 09151 5 5 9 amp 40 E 20 9 0 0 2 40 80 0 2 4 6 80 10 2 4 6 80 10 00000 mY mg D DO D D D EO D Dmu mr 100 y 0 8806x 0 4875 1015 02949 R 0 9812 80 R 209966 2 y 1 0499 0384 2 z z Ba 096 5 5 amp amp amp E E 40 E 20 0 0 2 4 6 8 10 0 2 4 6 80 10 2 4 6 80 10 UO U mg D EU D 0 Dmu ml 100 y 10655 05639 digi ral R 0 997 R 20995 y 0 9884x 01261 E E 60 R 09985 3 3 zi amp Ex er Ir mm 20 0 0 2 4 6 8 10 0 2 4 6 5 10 0 20 4 6 8 100 DOO mu mg 277 0 810 1 260 0000000000000 r 0 990 00 0000000000000 00000000 0000000000
345. I9 965602 OU PAT BT c p eE F GI I H k iJm 106 126 087 O88 087 O 0 999 0993 0992 0915 0 998 0995 0997 O03981 7 0997 0995 0998 100 098 090 6 117 122 130 105 093 106 085 099 loo 278 580 0o7zi 178 061 111 061 150 267 010 r2 0999 O994 0991 0910 0 998 0 996 0983 0 997 0997 0995 aseo asse 74100000 Do 0044000000000 00000 CVA 35 000 a 1 787 248 1783 336 3 1497 178 119 3487 626 179 dE 9610 1492 223 3491 777 5 2274 267 117 5305 990 187 ee EI E 2601 3 142 6082 1536 220 T b a Wo WORD BR A 3927 735 187 9224 2243 243 3 6780 957 141 15887 3391 213 T5555 5 1 099 025 248 236 057 24i LHO D 2 79 0 46 16 5 6 67 129 193 00400000 LHOO 3 462 100 216 1099 7 tHoo 14 4 567 130 229 1342 412 307 140 E h oo 15 5 1129 160 139 2702 636 235 120 A 16 6 1221 173 142 2871 676 236
346. ORI OR2 OR2 BRB BRA 25 BRA BRS BR5 C320 15 L 10 5 L 1 1 0 40 80 160 cut off 60 cut off O mo 00000 R 00000 R 17 1 4 au zu 28 5 8 19 2 21 21 2 2 1e 8 8 10 18 5 _ 8 10 O 1j 7 8 L 4 3 dq 35 3 14 30 4 O 304 53 4 5 LII zoo H Re ox e ANA 45 0 0 HEPASERA 1 0 D D 1 HEPASERA 1 Lot 070C MO 249 5 PBS pH7 20 0 09 000000000 UU HEPASERA 1 DU ane Sm SSA SS B Set 2 CENP B RNP Sm SS A SSB set 10 CENP B 040 026 07 00 024 030 050 2067 08 007 08 2007 05 2006 05 2097 07 2007 06 2007 06 2 PDO O43 07 010 015 D16 10 09 2s 30s 30s 2s 4 16s 18s Lm 2 23 1 95 17
347. PS1 x CAL 06 r p x CAL 9 e Pool 0 Singeg 0 02 Pool 0 00 Pool 0 00 05 10 15 20 0000 FTA ng 20 18 16 14 12 10 e HECTEF AS1 a m HECTEF C1 08 A HECTEF PS1 06 x ATCAL x CAL 04 Pool J al Sinda Pool 0 00 i Poopo 00 05 10 15 20 FT40 ny dl 20 18 16 14 12 B io HECTEF AS1 o gt HECTEF C1 HECTEF PS1 CAL 06 B CAL Pool O 04 Singe 0 02 Pool 0 Pool 0 0 Pool 0 00 05 10 15 20 FT40 ng d 20 18 16 14 12 E 5 10 HECTEF AS1 m 1 08 r A HECTEF PS1 os x CAL x CAL 04 e Pool O Singel 0 02 Pool Pool 0 0 0 05 10 15 20 374 U 000000000000 cvo 000000 2000250000 000 000 74000 0451 1 060 00000000 D UL tH apa unb B AS1 1 166 p nap n nun non u nan 662 00000799 14090 000 000 0000060 00000 O00 ng dL 159 19 D
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349. l rmean42SD U 40 0000000000000 0000 11 Guide to the Expression of Uncertainty in Measurement ISBN 92 67 10188 9 1st Ed ISO Geneva Switzerland 1993 20 International Committee for Standardization in Haematology Recommendations for Measurement of Serum Iron in Human Blood British Jounal of Haematology 38 291 294 1978 42 3 Iron Panel of the International Committee for Standardization in Haematology Revised recommendations for the measurements of the serum iron in human blood Brit J Haemateel 75 615 616 1990 4 Derman D P et al A systematic evaluation of bathophenanthroline ferrozine and ferene in an ICSH based method for the measurement of serum iron Ann Clin Biochem 26 144 147 1989 5 NCCLS Method Comparison and bias estimation
350. 0 OOOO 10000 20 q 70 60000000000 1000000 D 2006 2 nm ud 00600 UHH 670 114 1510 211 mg dL ASTO 140 56 U L ALTO 11 31 UAD 4 70 5 9 mg dL 6 60 7 2 g dL ALBO 4 1 4 5 g dL 0 50 0 9 mg dL D Bil 0 10 0 2 mg dL ApoAl 0 1180 156 mg dL ApoA II 270 33 mg dL ApoB 740 107 mg dL ApoCll 1 90 4 4 mg dL ApoClll 6 00 9 0 mg dL ApoE 2 90 4 4 660nm UU U U 0 1920 0 504 BHDE C ILDE C G0 0000000 0 U 0801 4 52 00 71 7 mg dL LDL C 1020 140 mg dL 0000 No 90 0 0 A 86
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352. 0 OU HOU Ud 90000 000000 58 0 00000 49 1 D Du 2 D uuu LU uut ud 90000 10140 1000 0000000000000 U4 90000 U 0 990 1 000 00 0 660 1 350 0000 OO 1000000000 0 990 1 00000 0 980 1 1508 0000000000000000 00000 BSG 3040 0000 OO OU OU 19
353. 0 0 0 0 0 U 10000 180 00000000 UIDDUDDUDUUUDUUDUDDUDUDUDUDUDBDDDBUDUDUUDUUDUGuDUuDUUuUD O 5 nm G GE EE E ES L1rrrrrrrrrrrrrcrrctd Title Research and Development to Promote the Creation and Utilization of an Intellectual Infrastructure Development of Reference materials for Laboratory Medicine FY2007 Final Report There is a great demand to establish the metrological traceability system to higher order reference materials from routine measurement data in the IVD MD in vitro diagnostics and medical devices in the clinical medicine because the clinical testing data which are obtained with different reagents and or measurement procedures in different laboratories are not always comparable with each other The comparability with the clinical
354. 0 0 Q 0 600 0000000 No 6 00000 000000800 90 225524 ET qu 10 0000000000000 HDL C ng dL 0000000000 0000000000 HDL C 6 15 65 2 U 0000 2 0 0 20 70 80 u F mM N m uuo ro o 60 5SJ rA 6SJ 00000 OO H HDL C 70 C0000000000 91 80 HDL C ng dL e i a 60 LN IK
355. 0 0000000000000 400000000 x NOOO Mh o n0 8 f SEE _____ a 5 20 0 0 1 2 3 4 5 6 7 8 9 Reaction time h 10 HFBA ITI I U D U D OOOOOO0SN 23 00 200pps00000000000000000000000000 080120000000 0 990 0000 O0O00000 U Thermoelectroni 000000 MS MS O TSQ Quantum Discovery Max 00 U 01 0 0 Agilent 0 2 0 mm Cadenza 18 Mim Q0 00000 0 1 00000000000 D uuu
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359. 0 50 60 u w y x 5 14 lo x 2 14 a 2 E S 09998 3 R 09993 40 20 20 40 20 20 20 20 0 0 0 0 2 amp 100 2 10 9 Sooo 0 2 p 9 Sooo tooo E E ele 5 sin Bs ES Bs o a E nr a En E w s El Hi E E m m m E sd So soem m 5 deja gt s oe FISCH das Bas est nn 58 0000000000600 13 13 12 12 11 ll ol 559 0 9 0 8 0 8 0 7 0 7 0 6 0 6 96 07 L XL 12 13 06 07 08 09 1 11 12 13 0o00 59 UHHH 0 0000 OU 1800000000000000000000N
360. 00 0 1 2 3 4 5 6 7 00 05 10 15 20 dan 378 12 Leng COD 120 170 000 0000 000 00000000060 cvo o aj rm b dd B BB BU LG OOOO000 00879 10910 000 000 0 p B 221 00000 000 0000 0 CU 4 09 0 39 1 e 1 76 e 202 2 88 195 lo6 120 cuu 1i
361. 00 0 8 8 8 1000 C 1000 0 0 0 1000 2000 3000 0 1000 2000 3000 ID LC MS pg mL ID LC MS pg mL e 000 e 00000 e000 e 00000 y x 3000 3000 2000 2000 a 8 8 a 5 E E 1000 1000 e 0 0 0 1000 2000 3000 0 1000 2000 3000 ID LC MS pg mL ID LC MS pg mL OO 339 OOU 3000000000000000 FIG OU OU 1 OU IDLO OU 14 IDOSO OUOU 15 as a x 1 205 22 84 0 999 0 820 51 47 0 998 1 005 35 30 0 996 1 141 51 16 0 982 0 878 42 21 0 999 F OF 0008 0005 00 2 ooo 4 al e 63 7 84 1 374 5 395 8 320 0 OO 30000000 2240 7 2361 8 2184 4
362. 000 D U B D Mn OOO D IDLAXLDLDJ 00000000 0 U HDL C GS Cinical and Laboratory Standards Institute 00000000 37 00 000 vali dati onl O00 U conmtabilityJOOOIUOO0000000000 1000000000000000 224 2 0000000 208 EJ CLS 37 I D DI s HUD C CASA TP 75 gd 58080 AB 45 gd _ cAG 150 s gt gt p proe B myd Papo 42 myd TA 0 0 0 60 15 30 05 TG 8 md 000 PI 1000 00000 a A A E J 224 2 J CCRM 224 2 VLDL 16 39 10 LDL 47 48 HDL 36 other 3
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365. 0000 0 0 200 00000000000000000000 00000 0 0 80 OOOO 10 200000000000 30 400000 0000000 000000 3000000 4D RNNEL 3 0 4 200 40000000000000 5000000000 Lun 1 2 3 4 5 6 7 8 9 ooo noo 01 411 FDP 25 0 20 0 z 1 d 2 A A3 15 0 a x5 10 0 Ms ES 7 8 E 5 0 2 0 0 0 0 5 0 10 0 15 0 200 25 0 u gml 01 00000000000 OOOO 160 000000 9000000000000 200000 ag 40000000000 NEN JJ 27 u gh UU D 5 8 FE O J 17 8000 370gnennnn
366. 0000 2007 11 080 0 0 159 000 177 00 0000 170000 2008 02 220 0 0 100 000 120 00 00000000 Ud 00000 19000 2000000 HI9G000000000000000000000000N tu 6 2 ui 00 00000000 0O 0 DEDE UH 0000 UHH cre seen 00000 61
367. 00000 Y m 3000 r m 2000 2000 E 8 E E ra C 1000 1000 0 L L 0 0 1000 2000 3000 0 1000 2000 3000 ID LC MS pg mL ID LC MS pg mL 000 e 000 e 00000 yY x 3000 3000 _ 2000 3000 5 o amp 2 S C3 4000 1000 0 0 1000 2000 3000 1000 2000 3000 ID LC MS pg mL ID LC MS pg mL 342 AE AE Ez E TEE Fe ea EJ 0 0 0 0 0 ESI E UE 3000000000 OU E Ho de aper T EJ L1 L1 L1 L1 L1 L1 L1 L1 L1
368. 00000 200000600 ST N SU 1024 5 100 0 10 36 101 2 10 34 101 0 10 37 101 3 10 22 998 1027 1003 1040 1016 185 8 186 100 0 102 20 2112 1004 102 40 2124 101 0 2127 1011 21 30 101 2 20 99 99 8 21 22 100 9 90000000000 5 0000000000000000600 0000000000 000000 Mg 00 1 5 mg dL 2 mg dL 0 0 10 mg dL 4 mg dL 00 3 15 mg dL 6 mg dL OU CH3COO 2Ca H20 CHsCOO 2Mg HH20 1 100mM NaCl 1 100 mM NaCl 2 pH50000 2 pH5 0000 3 0 2um 000000 8 O2um DD D U D D D mau LI LI 000000 900000 000 UA UN 00 1 5 mg dL 50 mg dL 2 10 mg dL 90 mg dL 00 3 16 mg dL 120 mg dL NIST SRM913a NIST SRM912a OU 1 0 1N NaOH 000 100 1 mg I 0000 100 mL 2 0 000000000 000 50 mM III l pH8 0 1 mM EDTA imu mmu LI 000000 umm 000 JSCCOOO AACCT OO 00000 HPLC 187 188 Glu Cre 00 1 100 mg dL 10
369. 000000 0000 The 1st International Standard U 0 14 my L for U 0 0 1 2 4 8 ng L U U 0 1 2 4 8 ry L 387 00 1myLD5 D 10 10mylpioDmn 10 20 1010 20 100mylp5p 388 90000 o BSAU 0000 8 Buffer O 0 20 50 Buffer 000 00000 Buffer 0000 1 5 GE ET STEER TA T cu ee Ee L1 dme L FEED Thak e 0 790 1 790000 2300000000000000000 e DUDDDUDDDUDDDDBDUDDDDUDUDDUDUGDUUDUDUDD 0 820 1 17000 1 4 14000000 0901100000000 e DUDDDUDDDUDUDUUDUGUDDDDBUDUDUDDDUDDUDUDUJUU
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372. 0000000000000000 95 000000000 440000 441000000 2000000000000 06000000000 5 4 270910 KNO 2 05U LI VK 0 2 09 YL 1 69 U LI ARNO 0 93 U LI 344 ULT 0000 163 0 0 0 0 DJ L370 71 80 100 bx 865 3 so Dd a 2 00 q 50 16471024 22 dj 581 10 0 20 0 U 1 37 C 0 100 200 300 400 500 10 U 137 C 01 00 000000 00050 0 0 0 D 00 1370 0000000 e100 RP soe eee ae Gua eee lola e Dx 7415 m 50 5 WEE SS u I Sor Be 2 00 EE 5o ee 9905 BO EE 0 340 1 020x 5 182 100 0 SD 233 0 100 200 300 400 500 000 0 1378 500 400 o f 300 3 200 100 0 0 100 200 300 400 500 10 D U 1 37 C 02 000000 00 000kN 164 B 8 U 1 37 C 8 8 200 100 0 100 200 300 400 500 10 U 1 37 C OO 00000000000 MK 10 0 5 0 0 0 5 0 10 0 U 1 37 500 300 200 20 0 U 1 37 C 100 0 100 200 300 400 500 10 0 137 04 000000 00000 AR VL 165
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374. 03 000000000000000000000000000000000000 D 20 2000000 iioii cvesuuu 2000 OOO 2000 100 99 989 b 1009 b 35 25 63 12 11 0 9 08 0 10 20 30 40 50 60 70 1 CP 1 0 CP 2 CP 3 A 4 CP 5 0 10 20 30 40 50 60 70 0 CP 1 0 CP 2 A CP 3 A CP 4 CP 5 J 12 11 0 9 08 0 10 20 30 40 50 60 70 0 10 20 30 40 50 60 70 0 0 CP 1 2 A CP 3 A CP 4 5 CP 1 0 2 A CP 3 A CP 4 5 0 10 20 30 40 50 60 70 1
375. 05 100 80 5 60 20 0 BOOG BHEPASERA 1 oJ w 90 HEPASERA 111 s 246 UO 900000000 00 UU D 2 1000000000000000 247 amp oa mg SIBISI Om 1 N Het 51515515 mm m e ze m m mimie e mimimimimimimi e x el 900000000 HEPASERA1Q 000000 20000 1600000000 00000 4 200000 248 HEPASERA I 000000 40 40 ORI 35r
376. 074 1 390000000 20077000000 8320 40 425 2007 39 0000000 20070 382 40 426 2007 00000 AST ALT 89 32 4 427 2007 HDL C 3890000 2007 320 4 428 2007 0000000 390000000 200700 000 320 40 429 2007 3900000002000 0000000000000 320 4 480 2007 1000 4460000000 20070 0 46 51 110K Kuwa Matrix reference materials for ionized calcium and blood gases measurements
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378. 0M000 I et 0 0 0 Oro 0 0150mm 1 0 SD DT DOT DD D 0 0 0 0 00 D 0000 UDDDDDDDUD mo 2090 0 000 51 200 000 jy gq ooo 021902015021007200 0 D D 0000000002000 400000000 00000000 00050 0000000 nnan nnnnnnnnn 00000 0 0 0000 00 00000000000 296 2007 4 18 0 000 00000000 2nd IS 80 5520 00 0 000 0 DB5IU 2 1st IS 96 602 Recombinant 189lU 0 2 0000000 img 0000000000 448 x40 0 16010000 3200000 0000 336 0 210 000 160 000 0 30 00000 00 072 694 0075 500 0 25000100 20 00000000 000 UU 000 287 00 160 000 000 210 00 160 00 095 100 100 2000 170010 20 x
379. 0SW 7 8 mm I D x 30 cm Buffer 0 1 Na Phosphate buf 0 15 M NaCl pH7 1 Flow Rate 1 0 mL min Detection 280 nm Sample Vol 100 3 HPLC 128 H4 SDS PAGE x Lane anpprcaimate molecular masses of 25 37 50 75 100 150 and 250 kDa 2 T stored al ATE dor over 3 years Native PAGE Lane 3 Prototype II sored FE dor 2 m lared Gel Palyacrytamide Gel 5 20 Stain Coomassie Briliant Blue T Gra proton proton F n pA specific coni pi minets 05 TOF 55 Prototype 200 00 0 0 20 129 67 kDa 505 PACE 67 kDa LU OO AHI U U 95 U eT 98 9 0 0 8
380. 1 In the feasibility study on screening tests reference materials it found to be very useful to use pool serum samples as a control material for E2 LH FSH FT4 and B2 microglobulin by the collaborative experiment among the participating manufacturers UH 0000 UUIDDDUDDDDUDUDUDUDUDUDBDDBDUDUDDUDUUDUDDUDUDUDUDBDUUDUGuDuDUUUD OU
381. 1 37 45 38 76 37 57 38 10 3859 3867 38 33 010 1 2 38 12 39 06 3887 3844 3888 3940 38 88 010 2 1 37 66 38 60 8794 37 90 3845 3884 38 35 010 2 2 38 09 3914 38 84 3842 3878 39 385 98 78 031 1 1 38 05 38 93 3952 3800 3878 3911 38 83 031 1 2 38 01 38 91 39 89 37 98 38864 39 10 38 69 031 2 1 38 05 39 48 39 05 38 71 39 26 39 54 39 17 031 2 2 37 72 89895 3878 3814 3884 3901 38 68 058 1 1 3843 3948 3972 3845 39 20 39 45 39 21 058 1 2 88 12 38 88 99 61 37 86 38 63 388 85 38 66 058 2 1 37 72 40 72 38 01 41 18 40 61 41 98 40 11 058 2 2 38 24 41 03 38 47 4142 4069 42 25 40 43 37 97 39 33 38 81 38 72 39 11 39 63 39 01 0 28 0 77 0 70 1 24 0 76 1 19 0 65 38 94 O00000 40 81 117 ymol kg Rel u 9 86 96 89 19 1 09 ymol kg Rel u 2 77 38 94 0 849 umol kg Rel u 2 18 395 O 000000 uaa 0000 0000000000000 uel 000000000 000 us 00000 2 2 2 _ Ucrm Uchar tUnomo tung 247 4 200000000000000000000 39 5 1 9 J pmol
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384. 11th Asian Pacific Congress of Clinical Biochemistry Beijing 2007 Chinese Medical Journal 120 Suppl 2 23 24 2007 120 Kuwa S Hosokaya W Tani M Tominaga and T Hoshino Estimate procedure and nm 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 OU OU 00 OU OU OU criteria for acceptable performance of uncertainty on hemoglobin A C measurement 11th Asian Pacific Congress of Clinical Biochemistry Beijing 20070 Chinese Medical Journal 120 Suppl 2 246 2007 130 Katsuhiko Kuwa Yasushi Takagi Naotaka Hamasaki Koichi Chiba andHideaki Imai Proficiency testing activities at JCCLS using human pooled serum and matrix reference materials in laboratory medicine 11th International Symposium on Biological and Environmental Reference Materials Tsukuba 2007 Abstracts WE B03 2007 14 Katsuhiko Kuwa Toshiharu Fukunaga and Wataru Tani Development of matrix reference material for blood gas analysis and their external quality assessment 11th 421 16 000 00000000000000000000000000000 000 540000000000000000 4700000000000000 200700000 5500 285 1700000000 540000
385. 12 ell ell 4 96 l 89 90 omo 1 0 6 52 83 eol 79 10 TOTS 11 12 H 13D 194 194 168 152 158 14 1 nm j 15 K pm T OT j f 16 naif naif 3202 9 90 133 132 129 141 118 141 Noo Ba 147 142 65 163 0 uum 0000 5 DDDDIDDUD 32200 Omon O jU O O 418 25810 00 4481 00 446 237 MAX MEAN LT D D 2581 D KLO OOOO A 40 7 C C 132 161 156 22 1 3128 3128 305 1022 1175 1175 10 7 11 1 15 33 15 33 14 1 112 1428 1428 89 1155 1155 107 0 242 pranan a 127 70 14 70 144 93 89 11 93 62 123 11 5 51 635 635 6 12 10 1210 6 1095 10 95 147 134 1355 SD MEAN 3SD 853 5 00 MEAN 25D 8 1 1601U mL OOOO
386. 1207 7 1273 6 1226 8 1148 6 33 25 1263 5 1157 8 1301 1 1223 8 1217 4 1210 5 1306 7 1176 2 1297 2 1218 4 1119 4 34 26 1219 3 1120 1 1291 5 1301 0 1162 0 1226 5 1197 7 1211 9 1278 9 1220 3 1051 6 36 28 2364 3 2274 7 2255 2 2270 3 2259 3 2258 3 2259 7 2259 5 2255 4 2260 4 2268 0 2271 4 37 29 2428 6 2286 7 2412 0 2175 9 2355 0 2401 9 2182 4 2295 1 2394 8 2296 2 2357 0 2326 0 340 cvi pr in cms nage nanc n nane nane ooo n an 00008 1 200 0000 3 1079 092 841 000 000 e 00000 3000 3000 2000 2000 4 gt 8 8 lt m B 1000 1000 a 0 L L 0 0 1000 2000 3000 0 1000 2000 3000 1000 2000 ID LC MS pg mL ID LC MS pg mL ID LC MS pg mL ooo e goood e 000 e y x 3000 3000 3000 8 2000 200 2000 8 8 8 cl oO E 1000 100 4000 0 L L 0 0 0 1000 2000 3000 0 1000 2000 3000 0 1000 2000 3000 ID LC MS pg mL ID LC MS pg mL ID LC MS pg mL van e 000 e
387. 1284 3 1262 4 1044 1 1076 3 1106 2 1224 6 12 4 33 25 1263 5 1469 3 1099 7 1315 4 1425 3 1108 8 1295 6 1229 5 1063 6 1068 9 1078 2 1219 8 12 0 34 26 1219 3 1421 5 1091 6 1398 4 1360 4 1123 4 1187 6 1266 8 1048 6 1070 7 1012 9 1200 1 12 1 36 28 2364 3 2886 7 1906 2 2440 3 2645 0 2068 5 2240 7 2361 8 1849 1 1983 1 2184 4 2266 4 14 0 37 29 2428 6 2901 9 2038 8 2338 9 2757 1 2200 0 2164 0 2399 0 1963 4 2014 6 2270 2 2316 0 12 9 331 1619 ID LC MS X 00 0 00B 59 37 92 73 0 998 0 997 0 829 19 17 0 999 22 06 0 999 72 72 0 999 98 44 0 995 112 38 0 998 49 75 80 85 0 998 0 996 39 57 69 25 0 999 0 998 1 090 5 32 0 998 16 27 0 999 0 817 50 55 0 998 66 73 0 997 0 803 29 31 0 996 29 04 0 999 0 934 15 34 0 999 1 003 45 25 0 996 0 828 72 29 0 995 29 38 38 14 0 996 0 999 0 859 12 29 0 994 15 25 0 999 18 29 0 999 43 58 0 997 1 119 29 69 0 999 0 928 51 14 0 999 0 874 37 83 0 999 54 67 82 35 1 122 7 98 0 997 0 903 40 05 0 997 0 918 64 23 0 996 0 964 75 65 0 998 0 800 93 66 0 998 1 179 16 96 0 998 0 945 55 05 0 996 0 830 34 56 0 999 42 40 0 998 58 31 50 77 14 25 0 9
388. 140 113 128 14496 95 294 183196 137 115 141 003000 BCR577 188 0 76 85 75 94 97 84 115 97 103 87 91 004000 BCR578 365 0 61 81 63 90 91 94 71 110 117 88 87 327 BCR576 e 0000 2500 p e ID LC MS m 1 00 e 2000 pP aci 00C E 450 CP Sse ce tea ae eo ee a 1000 esee zn e _ e e 9 ne e 500 B X 00H 0 i 0 i 0 500 1000 1500 000 I lt lt SSS lt Ss m e X 9 N S O pg mL S BCR577 e 0000 BCR578 e 0000 20 exce e ee e ehe curs 000 Z e M0 e 9 e e e v e e e e 9 e 150 e 800 a e e 100 L 200 e ibs sss a 10 E ar 0 0 1 1 lt c lt lt lt lt lt lt LC lt 9 cO Q9 lt amp lt lt lt LS KI QS amp LY 5 NU lt amp QS S POM LK LK LK LS 99 o8 QA qq QA OS OO
389. 1764 60 60 40 40 ES x PEN ta tt PEDR 3 p Ah 20 20 40 40 60 60 0 20 40 60 80 100 120 140 0 20 40 60 80 100 120 140 00000 miU mL mU mL 0 0218x 5 6653 00 y 0 0299x 21 019 60 40 40 20 20 cest Re V amp pa 0 9 9 5 5 E D 20 20 40 40 60 60 0 20 40 60 80 100 120 140 20 40 60 80 100 120 140 miU 00000 mu mL FS 1 0 0712 38 808 y 0 0102x 4 7989 40 40 20 20 0 9 teap r e 20 20 dai 245 60 60 0 20 40 60 80 100 120 140 0 20 40 60 80 100 120 140 00000 miU mL miU mL FSH OOO000000000 y 0 015x 10172 0 0988x 1 2748 60 60 40 40 20 20 A 0 0 Tet m 9 A 9 etes 9 20 20 40 40 60 60 0 20 40 60 80 100 120 140 0 20 40 60 80 100 120 140 miU miU m 309
390. 2 j a Pp 8 J K nonum 0000 HII munt 1 o o5 oo 022 0277 O1 ooo ooo 00 0 o 2 169 07 154 0906 061 087 096 09 3 0 3LH5 5 350 16 247 347 18 23 160 241 254 23 00 00 20000 1079 86 993 119 58 85 737 829 945 83 1 45 2 879 00 390000 000106 OO 049 O41 054 057 042 040 033 038 047 046 000 YOoOo Dou 111 008 004 069 074 040 014 040 044 003 1 7 292 2 201 225 DOD 048 os 055 057 053 040 034 039 050 044 DAT 4 1st 15096 602100000 00000 0000000000000 22 7 21 7 16 9 14 83 50 24 36 29 0 1782 1950 2407 216 100 4741 3504 3663 4597 439 86 0 40000 000106 035 037 046 044 xnnnn Ymon 000 016 011 006 0 12 1 7 297 276 207 232 uin 046 0 06 058 040 039 034 036 048 043 284 UU U O WHO2nd ISO 80 527 0 0000000000000000000000000 000000 evpgpeovies 000 266 c E F 105 nmn 2 55 m 0 993 0302 0915 0 998 0 995 0 997 0981 0 997 0 997 0 995 5p 0557 056
391. 2 0 999 12 30 23 77 0 998 0 998 20 87 33 04 66 57 0 998 0 999 0 997 17 28 0 998 20 37 23 98 0 998 0 999 0 858 53 71 53 03 0 997 0 996 55 52 00 0 8 4 2 00000 24 59 0 999 0 955 20 50 0 995 0 850 22 73 0 998 0 884 8 02 0 996 1 180 8 99 0 999 0 810 12 65 0 998 0 948 10 27 0 999 1 059 0 994 0 561 none vx e 000 v x 3000 3000 3000 2000 2000 2000 amp 8 8 8 a o B 1000 1000 1000 o 0 0 0 1000 2000 3000 0 1000 2000 3000 0 1000 2000 3000 ID LC MS pg mL ID LC MS pg mL ID LC MS pg mL oon vx 3000 3000 3000 2000 7 2000 2000 8 Ei 8 a ES C3 1000 1000 1000 0 0 0 0 1000 2000 3000 0 1000 2000 3000 0 1000 2000 3000 ID LC MS pg mL ID LC MS pg mL ID LC MS pg mL 000G X e OOOH 3000 3000 2000 2000 8 8 a a roy C3 1000 1000 0 0 j i 0 1000 2000 3000 0 1000 2000 3000 ID LC MS pg mL ID LC MS pg mL e ooo e DUDJ x 3000 3000 2000 2000 gt gt amp 5 gt a B 1000 1000 0 0 0 1000 2000 3000 0 1000 2000 3000 ID LC MS pg mL ID LC MS pg mL 330
392. 3 63 10x m uangn s RARE O 5 HE 0 0 0 D 001370 0 00000 DARVL 168 5500 SS 250 r ees ee E Bag SOO eee mp Gy e 18 500 150 450 600 750 DOLO p 1375 500 c E 2 B i i munnnn 0000 001370 Os cep ila EN e qa UD x 86 20 DD m i i I sr cad T o oe oe 100 i i D o 12x 150 300 450 750 jscquoen n 0 1370 300000000 5 010 000000 DOOOLAR VN 5002 Fras ot ee Ds 250 aU munnnn 00 amna aa a ea oa ad mmmme 1050 E 58000000005 q 500 Prechom 1 0 150 300 450 600 750 p 13741 O 00 0 041370 Dag 8620 Ed i F62 150 300 450 SCC BOPYI 1 L1 U 1 37 C DDD D 900000000 005 RD Precinorm Precipath 011 4500 OO JC ERM
393. 4 1190 1337 84 1154 1520 41 11 2 2467 2811 2627 26 37 23 67 26 20 24 67 2332 25 42 20 99 2551 62 23 32 2811 0032 33 zem Lm 252 z a 000 DDE DDF Duc OOH Mean 113 092 105 071 0 88 0 18 0 9994 0 9980 1 00 082__ 092 155 095 0 9975 1 00 Ia 112 177 077 09975 1 00 56 100 am a a 1115 19724 ra 60 2 im o R 09991 20 20 40 9 n F 60 0 20 40 g 60 10 u Bes n n E u o Mim nz Un aC ain s x x 5 F 0033 100 100 100 100 100 80 80 80 y 11074x 0 6367 R 09993 y 10271 07969 YEA INE pr on R 0999 R 09972 Rf 0 9841 60 Cy 60 2 x e a z R 09993 a 40 R 209996 40 40 y x R 09978
394. 47 00000000 2007000 550 U 340 OOOO 00000 0000 560 00000 2007 09 21 18 20 21 22 28 24 International Symposium on Biological and Environmental Reference Materials Tsukuba 2007 Abstracts P 53 2007 15 Katsuhiko Kuwa Shigemi Hosokaya Wataru Tani Makoto Tominaga and Tadao Hoshino Estimate procedure and criteria for acceptable performance of uncertainty on hemoglobin A C measurement llth International Symposium on Biological and Environmental Reference Materials Tsukuba Oct 2007 Abstracts P 63 2007 LU LU 0 Megumi Kato Sakae Eyama Mika Saeki Tomoya Kinumi Akiko Takatsu Development of C reactive protein CRM 11th International Symposium on Biological and Environmental Reference Materials BERM 11 Tsukuba October 2007 Migaku Kawaguchi Hisashi Kato Akiko Takatsu Isotope Dilution Gas Chromatography Mass Spectrometry for Determination of Cortisol in Human Serum 11th International Symposium on Biological and Environmental Reference Materials BERM 11 Tsukuba October 2007 Hisashi Kato Migaku Kawaguchi Akiko Takatsu Simultaneous Quantitative Determination of Cortisol and Progesterone in Human Serum Using Isotope Dilution Liquid
395. 50 VA 31 90 00000000000 FE Of 100000000 0000000060 OOU 500000000000 192386 5000 200 000000000000000000000 RANE unit JI 200000000000 60000000 209000000000000000 60 70000600 D uit 0 000000000000000000000000000000000000 400000000000000000000000 OlOIN OY BIW IN 414 6100000 opon 1 DD unit g mi 1 2 1 160 25 2 00 150 215 185 150 050 145 205 110 105 0 65 0 50 1 00 130 2 205 210 275 215 260 250 250 130 205 2 60 140 110 105 0 85 170 180 3 138 45 181 148 156 176 146 080 149 176 081 0 79 0 72 0 56 0 76 1 04 4 2 03 2 20 2 80 220 240 2 73 2 33 120 207 247 133 110 107 085 147 147 5 211 214 2 79 2 16 2 34 249 2 23 126 210 2 56 145 15 121 0 90 151 166 6 163 53 190 1 66 184 175 1 59 103 146 156 111 121 0 89 0 82 112 144 7 146 52 186 164 189 152 179 0 79 135 138 0 98 0 81 0 77 0 62 107 075 8 128 43 1 50 115 143 156 126 0 89 121 156 0 78 0 89 0 74 0 63 0 92 1 08 9 1 56 A 2 04 191 377 157 180 088 189 131 0 96 157 0 79 0 73 1 00 146 max 211 2 20 2 80 2 20 377 2 73 2 50 130 210 260 145 157 121 0 90 170 180 000
396. 5043 0 6493 0 6004 0 6468 05619 06812 06272 0 3840 0 4667 0 5406 04664 0 5300 0 5642 05701 0 5866 0 5135 0 4863 0 4159 06404 04527 05874 0 5408 0 5381 0 7071 0 4498 04539 0 4458 0 4678 0 5769 04745 0 5889 0 5685 0 5850 0 6185 05655 05315 0 0544 0 0524 0 0552 0 0267 0 0597 0 0300 0 0559 0 0777 0 1636 0 0880 12 11 10 6 10 5 10 13 29 17 CVs 10 x x O O O O O x x x FT4 ng d FT40 ng d 10 10 9 51 9 HECTEF AS1 m HECTEF PS1 y 0 4671x m HECTEF PS1 y 05207 il y 0 384x 8 A Singed D y 04667 7r UD 51 7 HECTEF AS1 6 HECTEF PS1 04863 6 D 0 HECTEF PS1 04159 E D 00 Singe D m 00 Gina n Hos 5 4 o 4 3 3 2 2 1 1 0 0 2 4 6 8 10 ED ID LC MSQHECTEF ED ID LC FTA ng d FT40 ng d 10 10 9 51 y 0 5497x 9 51 B 1 e HECTEF PSI y 0 5043x 8 A Sigel y 50300x 8 Sigel 0 7 HECTEF AS1 0 6404x 7 00 1 y 04664 6 00 HECTEF PS1 6 D HECTEF PS1 y 0 4527x E r i ees U Gmen lf a e B 5 Bg 5 DD Singe 0 4 a 4 3 3 2 2 1 1 0 0 0 2 4 6 8 10 2 4 6 8 10 ED ID LC ED ID LC MSCHECTEF FT40 ng d FT40 ng d 10 10 5 y 0 6493x 9 HECTEF AS1
397. 7 2 2 93 7 2 04 1 04 0 96 1 1 89 6 0 1 10105 939 0 9 88 8 0 9 0 1 10401 92 6 0 8 879 0 8 0 0 7 86 9 0 7 0 3 2041 0 97 3 0 6 85 7 0 6 0 3 05 0 94 5 0 5 84 1 0 5 03 0190 91 8 04 82 3 04 0 3 0 3 79 8 03 04 0 2 770 02 02 0 1 729 01 01 LED UU UUM D D U 000 mn 000 0000 000 0 0 4 910 4 264 1 042 0 99 9 2 844 2 25 8 1 04 0 98 4 1 75 8 25 3 1 0 40 5 98 2 0 9 74 2 09 25 9 1 040 1 96 2 0 8 724 0 8 25 7 0 7 710 0 7 25 2 2 0410 98 8 0 6 68 9 0 6 24 7 0 541 0 97 9 0 5 66 5 0 5 24 9 01 0 95 1 0 4 63 7 0 4 24 1 0 3 60 5 0 3 23 8 0 2 56 7 0 2 22 4 0 1 517 01 139 0000 8 6 95 Tu88E8 IgG 0 100 mg L 0 Tu66C7 IgG 10 5 10 mg LD 0 AMY2 10 mg L
398. 74 210 93 3302 098 033 236 062 876 167 2347 474 4460 638 9276 1476 012 020 100 026 229 051 844 179 2217 355 4323 885 8827 1653 oo oo oo lt mmn INOS vN S finiju WOlLWINIRIN IO 279 00 0000000000 A Bj C j D iege jr o H U J J K j tL J Mj le el ea m ES 1670 1109 1170 1130 1810 811 1220 552 1105 46 859 1004 1586 1183 1308 1244 1780 1200 1066 1136 1099 905 118 1178 1120 1430 1763 1163 1104 Ol u 77 St Se LE E 1590 1168 1235 170 1895 636 1157 1044 1095 1012 833 1539 1090 1218 1539 1299 1210 1773 691 1094 1028 1078 893 3 L ere el 350 565 770 az 435 480 320 494 694 36 45 32 48 50 46 38 asss an 436 914 378 440 B 409 537 478 418 509 9 407 535 564 427 400 335 383 462 452 433 466 seat S75 355 397 348 398 Sos aot aa A18 E E E EE E E S EEA 15 sl o sef s ll s l 2 azl moj waj mel 3550 59 590 256 420 360 358 457 415 389 446 487 388 563 580 388 409 356 390 481 432 405 441 3532 62 579 330 394 350 366 460 439 220 441 450 359 02 575 416 390 332 359 491 430 452 a
399. 8 0 28 CO 2 0 859 31 1485 118 13 CO 3 2 90 446 3 835 3 785 3 4075 CO 4 5 40 7 85 6 935 7 996 CO 5 15 56 18 13 14 315 17 49 16 95 0993 0 991 0 999 0 992 000000 1 096 0 886 1 116 1 078 000000 1 319 0 973 0 193 0 629 g dL ID MS 000 00 U g dL Fig ID MS 0000000000000 0000 88 UH 1 0000 L U uuu D Uu Uu DU Uu D uuu D uu D uuu OU 0 ESI E73 Lp EET 1
400. 9 3 664 0 541 8 782 5 800 1 650 5 682 4 17 8 32 24 1235 4 917 3 936 7 1376 0 1484 1 948 1 1022 0 848 7 1183 0 1231 5 1025 0 1109 8 18 5 33 25 1263 5 940 9 940 2 1284 0 1471 4 968 0 1031 0 826 6 1205 0 1223 0 999 0 1104 8 17 7 34 26 1219 3 910 3 933 2 1365 0 1404 4 980 8 945 0 851 7 1188 0 1225 0 938 5 1087 4 18 1 36 28 2364 3 1848 5 1629 6 2382 0 2730 7 1805 9 1783 0 1587 9 2095 0 2269 0 2024 0 2047 3 17 5 37 29 2428 6 1858 2 1742 9 2283 0 2846 4 1920 7 1722 0 1612 9 2224 5 2305 0 2103 5 2095 2 17 6 828 0 979 44 17 0 996 70 57 52 80 0 995 0 999 28 68 39 38 0 996 0 999 0 850 13 24 0 995 3 32 18 88 0 994 0 999 38 45 44 99 0 997 0 997 1 155 0 999 0 998 0 999 0 904 57 05 0 997 0 988 47 73 0 999 10 73 31 87 37 01 0 994 0 997 0 996 13 31 31 77 33 51 23 99 0 999 0 997 0 999 0 999 18 12 0 999 16 48 2 25 0 999 0 821 1 147 0 898 47 81 53 73 35 92 36 68 0 996 0 991 0 999 ru 20 0 D 30000000 0000 329 33 03 51 11 50 86 0 999 0 996 0 998 0 945 65 53 0 995 1 044 6 35 0 997 0 840 62 97 0 998 0 927 11 40 0 998 1 164 66 07 0 996 1 098 13 20 0 999 58 09 7 91 18 45 52 45 0 903 0 956 28 79 14 01 0 995 0 997 0 822 14 52 0 999 1 2
401. 9425 e R 08484 000 000 500 1000 1500 2000 2500 3000 000 5 00 10 00 15 00 2000 2500 30 00 00000 uu 3500 3000 3000 2500 2500 2000 2000 1500 1500 1000 1000 y 1 0945 0 29 0753 31667 500 R 09941 sor PSE 9 09045 000 000 000 5 00 1000 15 00 2000 2500 3000 000 500 1000 1500 2000 2500 3000 77 20 00 18 00 16 00 14 00 12 00 10 00 8 00 6 00 4 00 2 00 0 00 78 0 7955 29776 09426 Dx gt 0 7685x 2 9952 08484 Dx m 1 0945x 0 29 0 994 lt e y 0 7793x t 3 2775 R 20 905 Co EI H 1 1 1 1 1 0 00 0 00 5 00 10 00 1500 2000 2500 30 00 79 y 1 0732x 0 9421 R 20 988 1 2262x 0 3329 0 965 N e 1 1979 0 4279 R 0 998 1 1264 0 6689 ET E p3 FH na aA 1 11500 G Af f Oooo 10 00 15 00 20 00 80
402. 96 0 998 0 999 0 816 25 41 12 24 0 899 13 57 0 995 1 154 15 89 0 998 1 106 25 60 0 998 0 999 69 77 0 994 1 027 7 65 1 000 0 984 16 87 0 999 0 890 55 33 0 996 25 70 1 161 35 66 0 999 1 052 79 89 0 997 24 17 27 81 1 051 0 997 0 999 1 089 34 79 0 999 55 04 1 507 0 958 9 06 0 999 0 866 46 80 38 87 0 996 0 997 0 00 08 1 20 00000 0 905 42 01 0 954 0 991 0 999 OoooL oess 332 0 008 x e 000C 3000 3000 3000 2000 2000 2000 8 8 lt m o B B B C3 1000 C 1000 C 1000 0 0 0 0 1000 2000 9000 0 1000 2000 3000 0 1000 2000 9000 ID LC MS pg mL ID LC MS pg mL ID LC MS pg mL X e OOOF X 3000 3000 3000 9000 27 2000 2000 E 2 2 amp m amp a Lu a C3 1000 1000 C3 1000 0 0 0 0 1000 2000 9000 0 1000 2000 3000 1000 2000 3000 ID LC MS pg mL ID LC MS pg mL ID LC MS pg mL e 0006 y x vx 3000 3000 8000 9000 5 a a C3 1000 C3 1000 0 1 1 0 L 1000 2000 3000 0 1000 2000 3000 ID LC MS pg mL ID LC MS pg mL e 0001 e OO 3000 3000 8000 e 2000 8 8 a 1000 1000 0 0 1000 2000 3000 0 1000 2000 3000 ID LC MS pg mL ID LC MS pg mL
403. 9987 0 9992 0 9993 0 9980 0 9953 1 04 0 76 0 87 0 81 1 04 0 37 1 64 0 90 2 42 3 30 2 34 1 32 2 74 2 11 0 33 0 90 2 65 0 99 1 00 1 00 0 99 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 SD 25 83 r POO PO C15 V e nu 10 73 257 I 78 199 919 25403 117519 391 319442 39960 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 4 002 95 10894 1480 13 No 160 140 ES 100 0000 080 0 00 0 060 v 040 1 16 0 68 0 94 0 88 1 23 0 54 0 10 0 29 0 9987 0 9992 0 9993 0 9980 0 9953 0 97 1 16 1 08 0 93 0 98 1 16 2 40 3 28 2 40 0 24 0 85 2 03 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 1 00 312 3 BEEP ooo e x g0 29 1759 033 83 142 026 17957 25 pat L NA 6862 1382 201 5775 1159 20063
404. C Set temperature2 800 C Injection 10 pL solvent flush with 5 pL of MQ Range Range 3 Integrate mode Auto mode 220 0000 U mol DDD OOO AU EELELETI 40 84 40 51 41 86 001 40 68 0 59 008 40 64 0 75 018 41 17 0 69 D uu Dunt 40 81 1 17 pmol kg HD B DJ 0000 y g s U 00 U U umolkg U Auka 000000000000 Biochemika Ultra 0000000 puumQ OOO 00000000000000000000000000000 218000 100 221
405. CC mmol moll 162 1 DDU D UUIFCC NGSP 0 0 DD DU DD 00 0 NGSP j IFCC mol 0 0000 NGSP HbA1c BH 000000000 IFCC HbAIc WG 20010 00 20070 0 60 DB U U D D IFCC II CE NGSP 1 000000000 0 00000 Master Equation IFCC NGSP O 0 00000 000000 NGSP 0 9148 IFCC 2 152 OU 0 FCCOOO00 0 00 000 0000000600 NGSP 0 0915 IFCC nrrol mol 2 15 2 00000 00000 NGsP I T DIFCC O Dmmot 000 00 000 0 5 IFCC 0 Ko500 00 000 0 0000000000000 00 00 4PLcg II DU D 000000 NGSP HbAIcO 00000 0 000 0 0 OO 0000 0 0000 00 00 0 0 CDD D D 0 00000 00000 00 NGS 1 IFCCI BeAre D D D 00 00 NGSP HbAIc 000 o 0000 4 5 5 50 0000 200m 0 00000 000 0 05 50 6 50 00 00 0107000 0000000 OOOO 000000 000000 00 0050 A 195 080000000 0000000600 31 5 5 65070 8090 10 00000000600 OO 1000000000 000 000000000000 0 8000 0000 e 5
406. CCIIIUDU U 20 2007 05 10 2007 09 23 2007 10 22 2007 11 24 2008 01 10 UH 150 50 mmol molQ 000 20000000000000000000000 00000 150 250 mmol mol 300 500 mmol mol 0 2 mmolA UH 0000 1500 500mmol molQ 0 U O U D 1500 2500 3000 500 1 5 UH
407. CTEF 388 OHHH 2 0 20 00 00 7100000000000 UUDDDUDUDBDDDUDUDUDUDUUDUUDUGuUnUDDUDuD D Uu UD 000
408. D 14 4 x x O00 BPO 7 1 x x 7 95 U LU LU 0000 Beg 2 7 O O 0000 eo 2 8 O 000 5 3 8 x 3 2 O 000 Beg 1 8 O 118 95 A 00000000000000000000000600 UHHH 00 UUIDDUDDDDUDDUDDUDUDUDBDDBDGUDUDDUDUUDGUDDUDUDUDDDBDUuDUuDUUUDU e e e POOR OOo ae ooo E
409. DUDUDUDUDUDUDUDUDU 389 Dt x mms Butter OE 1 065 021 091 1 61 052 092 1 05 oaa Oo Qui 1 06 1 12 1 os 1 00 og 1 6 E 1 38 087 1 00 i agaj 1 5 1 18 1051 a Lg 1 07 1 036 O96 7299 FER tp 5 8 mw ig EUR VOR adi HOES TEST e 0 0 0 860 1070 000 5 9 0 00000 0 000000000000000000000000016 15000000 0 900 110000000000 e DUDDDDDDDDDDDUDDUDUDUDUUDGUUDUDDUDDUDUDUDUDDUDUDUDUUJDDUUUD 390
410. DUUUDU 14 8 10 0 1431 1 268 1L MHO m L D WHO std RF D C 599 RE TOMO 0000 599 IIIIII 892 1 1 1 1 322 020000093 mri 23 96 60 67 5 40J 120 LM 926 857 n 849 124 _ 280 280 366 Im 816 im 95 _ 65 6O 49 960 10 0 10 0 10 0 67 9 10 0 10 0 r 1175 13 0 13 0 13 9 120 110 106 1225 100 94 14 7 0 264 RF 0000 5 No inn ln 999 892 1000 1 M II 11 16 8 158 168 2B 09 52 52 j 36 08 117 117 11 130 130 m 12 18 8 188 j i ell 12 155 155 I 184 184 240 185 192 8 A
411. Diabetes Society Japanese standard reference material JDS Lot 2 for haemoglobin Alc ll Present state of standardization of haemoglobin Alc in Japan using the new reference material in routine clinical assays Ann Clin Biochem 42 47 50 2005 12 Q000 000000000000000000000 0000000000 HbAte l 489 7 541 547 2005 13 NCCLS Method Comparison and bias estimation using patient samples approved guidelines Document EP A ISBN 1 56238 283 7 1995 NCCLS Wayne PA 14 Passing Bablok W J Clin Chem Clin Biochem 1983 21 709 20 1984 22 431 45 36 UHHH und a DU LU 8 100 5 LU UU
412. E e e a a a a a 5 a 5 EE 5 0 0 0 0 0 5 10 15 0 5 10 15 0 5 10 15 0 5 10 15 0 000500 00 0 0 DOO MO OD O y mg non rmn o DU Ing mg 75 75 75 75 3 50 D 50 50 3 50 gt 00 ase eee 5 00 e m E z 20 pe 00 emo ase 5 E 5 10 15 159 5 10 1 254 5 10 15 es 225 5 10 ib a 75 5 75 a 75 0000000 0 0 0 my mg ooo 00 0 0 0 mmu 00000 8 OOONONN B 12 LT 000 0916 0 321 oll UY CU i D 0 00 1200 0584 PIE 000 0926 0 243 10 e 4 0 0 00 0 977 0 091 Blas ie J Flo 0 00 1 027 0 158 c 000 1 020 0 032 T 0 00 1012 0 225 i l 0 965 0 126 T 0 996 0 916 0 584 08 09 10 11 12 13 1 000 1 205 0 243 000 9 D 70 gupgupnupnpupuggaupdgumupdudmsauugugdupugiuibpiutlulu D E
413. G5 PNP 1826 149 439 0993 088 113 1868 421 226 O 1773 1903 O O 129 101 11BG5 PNP 1638 170 439 0994 119 099 1628 100 061 O 1550 1 06 O 093 076 EGE PNP 1 8 439 0287 170 0861 1408 0821 058 O 03 O 129 083 L HBIEGEPNP 152 093 439 09911 1551 097 1632 188 1221 B29 1231 O L 1098 x x 0 143 000000 ERMOOOOOO OU No 000 0000 95000 0000 1 GalG2 2 GalG2 CNP x x x 3 GalG2 CNP A O x 4 GalG2 CNP x x x 5 GalG2 CNP x x x 6 GalG4 CNP O O O 7 BG5 PNP 8 BG5 PNP O O O 9 BG5 PNP O O O 10 BG5 PNP O O O 11 BG5 PNP O O O 12 EtG7 PNP B EtG7 PNP O 5 95 DOOOOOUUO A 10 x 11 5 x 6 5 00 X 6 UH D Uu 7070 7170 20000 71800 0000 TBA 80FR Neo Lot 005 DU uuu D uuu D uuu D uuu 000000 SAMY
414. H UH 0 Traceability in Laboratory Medicine UO 000 OU BU UU U 0000000 D uuu 0000000 Joint Committee for UUUUUUUUN OUD 00000000 0000 UUDDDUDUDUU 0000 00000000000 DU 00000000000 DU Uu UHH 0000 190 40 23000 1000000000000000000000000000000 200 10 17000
415. IS 80 552 35IU I 130 mL 000 000 nnnmn mp _ 00000 000000000 00 0 0000000000 QOOOOUUU0000000000 0000000000000 298 LH 200M1U mL 10 00000 04 000 00 000 000 0 Lot oooox 200 100 50 20 5 2 0 0000000 2 D2 2 D 012 2 D Rr J 0000 DD 3 3 3 3 3 3 3 3 1 1 1 1 1 1 1 1 0 OOOO 16 16 16 b b b 16 16 8 D d D ad 0000000 0 00 00000 0000000000 000 00000000 16 Jecesnma 0000000 0 20mU mi 21 50miU mL 51 200ng mL 9000000000 200 12 0000 3 15 1000 00000 0000000000000 299 J CCLS 000 odd odd Cr 5 LH
416. MG 00000 m B2MG 00000 106 020 000000 ose om DITNo5TI MS 0 0 0 0 09 DONO SOs 0000 R 100 R 100 z 50 50 50 Eu o 40 i D P ud U 30 0 30 N p N 20 20 20 410 510 s 0 0 0 10 20 30 40 50 0 10 20 30 40 50 0 0 10 20 30 40 50 00000 myL 00000 ae mgL 82MG 00000 100x 006 B2MG 00000 101 4025 B2MG 0 0 00 D y 090 073 0007010200000 R 100 DITNo8TIVSO 0 0 0 0 00 R0 D D n D 09 R 099 50 at 29 040 D 40 D 40 0 1 30 QUT gt ET di 30 N N N o 20 o 20 20 s 8 10 910 j 0 0 0 0 10 20 30 40 50 0 10 20 30 40 50 0 10 20 30 40 50 mgL myL ooooo myL B2MG 00000 1 00x 005 BMG 00000 105 009 B2MG 00000 107x 068 mL DITNo10 TMS 0 D R 099 DITNo 21TIDvsn 0 0 D R 099 DITNo12TIDvsD O D O O R 100 50 50 50 0 0 ue 40 0 40 v 40 M M gt u 9 35 920 1 10 5 1 110 E ae 2 0 0 0 0 10 20 30 40 50 10 20 30 40 50 0 10 20 30 40 50 nonna myL nnnnn myL B2MG 1 00x 040 B2MG 00000 107 012 mur B2MG 00000 y 105 039 HS DITNo13T M D 09 R 1 00 mg i DIENo 4IDvsD D 100 DIENo 35 DOE D D D 0 09 R 100 50 a ges ao 0 50 40 040 md D 40 0 pad 0 x EE ii 0 20 920 9 20 110 110 110 3 4 5 0 0 0 10 20 3
417. R 0 9835 y 05926 R 0 9201 CHNWAUDAN O 2 4 6 8 10 4 6 8 10 N ED ID LC MSQHECTEF ED ID LC MSQHECTEF 380 FT40 ng d 10 9 81 y 0 5735x 0 1731 R 209657 7 E 6 B5 m 3 2 1 0 0 2 4 6 8 10 ED ID LC 5 FT40 ng d 10 y 07032 0 312 R 0 946 000 O o N Q BU Oo o ED ID LC MSQHECTEF ell 0 0 0 ID LC MS0 00 0 000 0 0 0 m00 0 yooo 900000 18 2 ED ID LC MSQHECTEF FT40 ng d 10 9L y 05442x 02568 R 209831 Tok 6 Bor 4 3 F 2L 1 L 0 1 1 1 i 0 2 4 6 8 10 ED ID LC FT40 ng d 10 9L y 0 5424x 0 1088 8r R 0 9338 7 6 f amp 5f 41 3L 2 y 0 5609x R 209323 1 0 i i i i 0 2 4 6 8 10 FTA ng aL m o y 0 6383x R 20 9348 00000 v a y 0 4343x R 208753 N RUOAN 0 2 4 6 8 ED ID LC MS 10 l 0XX gt E ooooooqoooooonon 000 381 DI 141
418. UDUUDUDLUUDU 75 OU NIST SRM921 AIST OO00 0000 ETE EE NIST AIST 76 3000 2500 2500 2000 2000 1500 1500 1000 1000 500 y 08347x 3 1245 4 06372 24835 R 0
419. an serum albumin HSA FEE 1 1 ees E E Ee EXE E 0 0 0 0 0 0 0 Ooo OH OH 0 0 0 0 0 0 EZ 0000 gt D DD U U 30 mg dL 300 0 U Prototype 10 Prototype I OU D000000000000000000000000000000000 m 0000 O U Prototype Prototype n0 0 0 0 0 E SET nu ES
420. dures In the case of urine containing elements sodium potassium chlorine magnesium calcium urea nitrogen of urea creatinine glucose and inorganic phosphorus and inorganic phosphorus and lithium in serum we selected the candidate reference materials and evaluate their stabilities as a reference material The matrix type of reference material of urine can be produced according to the protocol obtained in this study The matrix reference materials of albumin and amylase were characterized As for lipase preparation method of reference material was decided through collaboration experiment among participating manufacturers In the next financial year the reference materials of HDL and LDL cholesterol and glycoalbumine will be nominated to the next cycle of JCTLM Database On the other hand in the case of pure substance type of certified reference materials CRM whole the development and certification process of the C reactive protein CRP in buffer solution CRM was completed and it is available to be disseminated to the market It will be nominated to the JCTLM Database in the next year As for the albumine CRM the definitive method for characterization was developed As for the cortisol CRM the high purity primary reference material PRM was selected the preparation method of candidate CRM was developed and the definitive measurement method of characterization was established The coltisol CRM will be developed with uncertainty less than
421. exews numA uuus unmc unupb n une n auo OOF n aui 000 9 ood 1 11 1 15 4 30 5 lt 20 19 1 28 7 31 7 34 3 14 9 17 8 14 0 21 7 39 5 10 2 23 8 29 1 53 6 lt 20 32 4 51 0 48 9 50 1 25 8 29 0 21 6 36 5 34 9 12 4 68 1 57 1 106 0 TTA 61 9 89 2 95 8 97 1 75 5 73 8 68 9 79 1 19 9 15 7 127 5 102 2 162 4 132 8 114 1 177 0 136 1 174 3 143 8 140 7 121 4 139 3 17 2 17 9 177 9 144 3 197 6 154 4 162 4 206 6 187 6 225 1 190 5 176 4 169 9 181 1 13 0 19 11 226 0 204 9 278 0 239 4 264 2 263 2 261 6 319 5 261 6 250 0 223 0 253 8 12 2 22 14 335 9 305 2 420 7 329 3 404 4 404 2 393 7 394 7 426 5 394 3 346 1 377 7 10 9 25 17 345 1 372 9 458 9 463 4 435 1 427 7 472 9 562 6 460 2 425 2 377 7 436 5 13 6 29 21 650 3 619 5 782 0 666 1 716 2 718 5 725 2 749 6 790 9 758 3 662 5 712 7 7 9 30 22 728 1 655 8 819 2 739 8 780 8 794 2 877 1 803 6 878 2 830 7 759 4 787 9 8 4 32 24 1235 4 1175 6 1351 5 1366 2 1279 8 1235 9 1350 1 1258 8 1327 7 1278 6 1196 6 1277 8 5 1 33 25 1263 5 1205 8 1356 5 1274 8 1268 9 1261 8 1361 9 1226 0 1352 4 1269 8 1166 2 1273 4 4 9 34 26 1219 3 1166 6 1346 5 1355 3 1211 1 1278 5 1248 3 1263 2 1333 3 1271 9 1095 6 1253 6 6 3 36 28 2364 3 2369 0 2351 2 2365 0 2354 8 2354 0 2355 3 2355 1 2351 2 2355 8 2362 8 2358 1 0 3 37 29 2428 6 2381 5 2514 7 2266 7 2454 6 2503 7 2274 7 2392 2 2496 5 2393 2 2455 6 2414 7 3 5 0 337 1
422. gt DITNo amp TIsO DD 00000 09 R 100 DINoST Ms 000 09 R 099 50 50 40 sae 0 an 0 40 D i s P is md N o 20 y 20 o 20 710 320 910 0 0 0 0 10 20 30 40 50 0 10 20 30 40 50 0 10 20 30 40 50 000000000 000000000 myL 000000000 myL U 10 ZU 30 a0 5U 0 000000000 0 10 20 30 40 50 0 10 20 30 40 50 000000000 000000000 mgL BMG 000000 y 097 018 myL B2MG 000000 y 103 023 apu B2MG ly 104x 056 00010000 0 00 0 0 R 099 11 5 09 R 099 12 5 D R 100 50 50 D 0 40 0 40 et 5 FEY 9 20 920 110 110 1 2 0 50 0 10 20 30 40 50 0 10 20 30 40 50 000000000 00000000 T 000000000 igi 0 10 20 30 40 50 0 10 20 0 40 50 gue I 0 10 20 30 40 L 000000000 mg L 000000000 myL B2MG 000000 098 053 BMG 000000 105 000 BMG 000000 103 027 mgr 0004130 0 0 00 00000 R 100 ud DITNo14T vs D 000 0 0 09 R 100 ds 00015000 D DO 000 R 100 D x E 50 p xe ga umm Jo m ES PES 1 30 N 20 920 920 110 1 3 A 10 110 0 0 0 0 10 20 30 40 50 0 10 20 30 40 50 0 10 20 30 40 50 no 0000000 000000000 000000000 0 aet 10 0 40 x 0 10 20 3 40 50 mg L nn nn nn m n 1 B2MG 000000 0 94x 007 B2MG myL DrrNoaerTiDvsn 00000000 X R 100 000
423. imidyl carbamate and application to Ne carboxymetyllysine and Ne 1 carboxyethyl lysine modified albumin Biochem J 364 1 14 2002 8 NCCLS Method Comparison and bias estimation using patient samples approved guidelines Document A SBN 0D 41 0 000 00 4 1995 NCCLS Wayne PA 9 Passing Bablok W J Clin Chem Clin Biochem 1983 21 709 20 1984 22 431 45 25 UH 1 0 0 0 DU uuu 0 0 D uuu U uuu DUDJ nm 00 EY E 5 Ea SESS OU 3000 OU 0 U 400000 HbAtq LJ Eug EE 15
424. in Chim Acta 324 61 71 2002 2 Shima K Ito N Abe F Hirota M Yano M Yamamoto Y Uchida Y Noguchi K High performance liquid chromatographic assay of serum glycated albumin Diabetologia 31 627 631 1988 3 Paul J Thornalley Annika Langborg Harjit S Minhas Formation of glyoxal methylglyoxal and 3 deoxyglucosone in the glycation of proteins by glucose Biochem J 344 109 116 1999 4 Phillip P Minghett Duane E Ruffner Wun Jing Kusang Oliva E Dennison James W Hawking Wanda G Beattie et al Moleculer Structure of human albumin gene is revealed by nucleotide sequence within q11 22 of chromosome 4 The Journal of Biologycal Chemistry 261 15 6747 6767 1986 24 5 John W Baynes Suzanne R Thorpe Martha H Murtiashaw Nonenzymatic glucosylation of Lysine Residues in albumin Methods in Enzymology 106 88 98 1984 6 Piraud M C Vlaney Saban K Petritis C Elfakir J P Steghens D Bouchu Ion pairing reversed phase liquid chromatography electrospray ionization mass spectrometric analysis of 76 underivatized amino acids of biological interest A new tool for the diagnosis of inherited disorders of amino acid metabolism Rapid Commun Mass Spectrom 19 12 1587 1620 2005 7 Nalia Ahmed Ognian K Argirov Harjit S Minhas Carlos A A Cordeiro Paul J Thornalley Assay of advanced glycation endproducts AGEs surveying AGEs by chromatographic assay with derivatization by 6 aminoquinolyl N hydroxysuccin
425. loon loon toon toon toon toon eu Eee T INT 81 830 569 72 651 727 746 648 507 690 210 507 830 2 N2 218 21 93 1863 195 1864 1945 2062 1822 1255 1904 222 1255 2193 3 N3 43 76 35 89 378 37 29 3790 3951 3528 2462 3713 221 2462 4376 4 IN 4 6728 52 87 594 5932 6070 6152 5373 40 50 5761 19 4050 6728 5 IN5 911 9081 83 77 82 1 8348 86 34 89 35 77 30 60 72 82 77 15 5 60 72 9110 11 43 472 369 440 372 407 407 398 232 392 294 232 472 12 2 1 32 167 161 160 140 163 152 106 094 163 687 094 320 B 31 53 392 367 400 352 392 375 3 46 229 376 338 229 530 14 41 62 540 449 540 495 505 503 470 292 490 305 292 620 15 51 29 144 148 140 122 147 150 092 089 147 659 089 2 90 16 61 72 595 530 5 50 571 622 6 00 5 00 351 5 60 286 351 720 17 7 1 4 392 313 400 374 372 383 331 220 357 283 220 430 18 8 1 7 5 62 553 620 6 04 610 610 5 43 352 577 29 1 352 740 19 91 138 1109 893 1010 947 916 928 974 1020 165 893 1380 20 10 1 730 512 600 559 577 551 521 353 584 396 353 850 21 11 1 862 31 r2 32 22 33 32 34 4 2 35 52 36 62 37 7 2 38 8 2 39 92 40 10 2 41 11 2 000000000 wWmoooo 00 0 2 100 100 100 100 80 y 1 0525 20894 80 L 11577 01729 80 80 09983 y 10319x 05643 60 60 09933 00131 lt o lo a R 09994 To 10888 09575 E 1564 io To 09944 0 7393 en y 10043x 14935 R
426. m sm e aon ap ep wes DOGO 1 pus ref asm cm aep nep sep sm a pie e m vn om wei ep icum c aum xu ep p De E c pe comp m e mb sm e sep e we pee p om ep em ne ue um cm cm am Em s se 22 am nam ae nep se me Fs o am m m eof an e ul ej ws wi un erp op um Dum uei oot um up m ne m erp rep Ls ep e camp ep un cm m em c pel ce ef a ue cen cep aos om mj asp up up xe eb o cep um Ui 368 000 1 OF 3D 0000000 1 0000000 0076 13100000 00000000557 00000 FT40 ng d FT40 ng 8 8 7 y 0 6651x 04294 R 0 9865 y 0 7754x 0 0399 6 6 R 0 9822 5 5 y 0 7618x a R 209153 u pude 4 B 3 2 21 1 1 0 0 0 2 4 6 8 0 2 4 6 8 ny dl ng 8 8 7 y 21277x 00916 R 20 9827 7 y 0843
427. mg dL 00 2 200 mg dL 50 mg dL 00 8 500 mg dL 100 mg dL NIST SRM917b NIST SRM914a 000000 000 JSCCO OO JSCC D D DL D D HPLC J l D D D HPLC U l uIP 001 6 mg dL 005 2 12 mg dL 00 3 24 mg dL LU NaH2PO4 UUUUUU 000 000000 000000 000 u U uu OO Cal CRED Glug IPO O O 200000000 18017025 ISO Guide 340 00000000000000000000000 l O00000 OU CRM 001a0 00000000000 25
428. mperature Solvent Gradient program Flow rate Detector Injection volume Sample temperature Time B Acetonitrile C Distilled water Time min A96 0 01 100 0 5 99 18 95 19 91 29 5 88 38 0 41 100 50 100 Conditions Column 8 9 mm I D x 150 mmf 35 C A AccQ ITag Eluent A Waters B 96 5 x Qu 1 mL min Multi fluorescence detector 2475 Waters Ex 250 nm Em 395 nm 10 pL 4 C 50 min 9100000 O09 U U pmol kgf 0000 Ala 1 1 001 2 2 1 1 008 2 2 1 1 018 2 2 98 80 98 48 38 69 38 84 38 40 38 47 38 28 37 62 37 92 37 98 36 91 37 22 38 14 ON N H N H N NH 0 63 223 Leu 41 17 41 13 41 11 41 12 41 09 41 14 40 06 40 40 40 12 40 37 39 37 39 86 40 58 0 63 Phe 40 28 39 85 39 99 40 01 39 88 39 95 39 31 38 99 39 17 39 09 38 30 38 32 39 43 0 67 C 96 So Pes oso S Pro 39 09 39 22 39 42 39 73 39 26 39 12 38 76 38 82 38 79 39 11 38 42 38 55 39 02 0 37 Val 38 93 39 12 39 36 39 19 38 84 39 35 38 19 38 55 38 37 38 40 38 59 38 63 38 79 0 40 39 19 umol k U 10 0000 umol kel ogogo Ala Leu Lys Phe Pro Tyr Val 010 1
429. mtu mD rmiU mL mIU mL DmlU mL mlU mL FSH 1 29 1 7 2 4 1 8 1 6 1 8 2 0 2 0 1 1 17 1 6 0 2 30 53 9 5 7 0 6 3 7 5 7 4 8 2 4 0 6 6 6 4 FSH 0 3 31 9 2 17 8 11 6 143 18 4 12 5 14 3 6 9 11 3 11 2 FSHD 0 4 32 16 5 30 4 20 2 19 9 23 3 22 3 26 5 13 7 21 1 20 6 010 90 183 358 246 251 257 251 31 1 FSH 0 6 34 23 9 36 9 30 5 29 8 340 33 8 38 3 19 7 30 9 28 2 FSHQ 0 7 35 36 5 617 44 9 449 49 8 49 6 57 9 31 0 46 8 44 9 FSHD 0 8 36 54 1 96 2 68 1 724 792 75 1 88 9 50 4 67 9 68 0 0 9 37 822 1636 106 6 1158 124 2 124 0 138 8 790 110 1 1056 5 3 4 7 6 14 5 22 4 31 6 201 0100 210 44 4 50 8 58 9 68 0 72 8 O00 000 1 21 MOU D 1 9 l 0 194 19 4 mo 90 YOO 210 0 9995 0 9932 0 9987 0 9994 000 YOO 0 9997 0 9966 0 9994 0 9997 goood ID uu 307
430. o 50 o 50 o 75 75 75 75 OO D O O O O D Ong mui 00 0 mg mig enuun u ODDDDDDD 9 9 9 G 5 moe nS y 0 937 x 0 126 5 y 0925 x 0246 1026 0 017 ennn y 1019 x 40023 ep acu 0097 y 20937 0037 y 0991x 0111 a 10 10 a 10 10 a E B z E 5 o 5 5 o 5 0 0 0 0 0 5 10 15 0 5 10 15 0 5 10 15 0 5 10 15 0000y mg 000 0ng mg 000 ng mg 000 Ong mg 75 75 75 75 A a 50 50 50 E 35 Er m 35 E 25 D 00 D 00 909659 we 00 4500 490800 Qy 00 lemne a0 dte m 25 5 10 15 Er 5 10 15 1 25 5 10 15 a 25 0 5 10 15 m 50 m 50 o 50 o 50 Dm 75 EY 5 m 75 75 D D O ny mg ng mui O Ing mp D Ong mui 9 9 9 9 OHOOO c 0 996 1 252 0 098 0 998 1148 0 306 Deer 19 0 993 0 873 0 424 0 997 1 053 0 087 5 iF 0 997 1 013 0 538 0 997 0 939 0 294 0 998 1120 0 029 0 998 1 096 0 074 ip 0 998 0 991 0 132 0 999 1019 0 023 1 000 0 937 0 126 0 999 0 957 0 097 0 999 0 925 0 246 0 999 0 937 0 037 1 000 1 026 0 017 1
431. oxy D glucitol 1 yl L lysine 22 UH N 1 deoxy D fructos 1 yD L lysine A Q deoxyD fructos1 yD L lysine 00060 mmol ml O U U N 1 deoxy D fructos 1 yl L lysne 7 DO 0000000000000000 00 0 ID MS D Uu U U 258 8 471 18 mmol mol 95 20000000L
432. rL Glucose 6 phosphate dehydrogenase _ 15 U mL LUL gi joi Diolein 18 mM 0 6 mM MgSO 2 nM 2mM mAbs1 min mAbs2 rin LIP LL X 25x10 6 3x10 x0 1 H7080 1 160 uL II 80 uL 10 0340 nm 405 nm 37 27 31 mAbs min LIPO O U L X 02510 6 3x10 x0 01 162 4320000 1000000600 OO 580 000000000000000000000000 75800000 0 000 2100000 400 50800000000000000000000000000000060 4330000 1000000 OOOO 500 0000000000000000 00000000 006000000000 OU 210000000000 OO 560 00000 0 1970 00000000000 0 0000000000000 0000 000000 OO 580 0000000000000 0 0 2 0000600 0000 5000000000
433. stic Medical Devices IVDMD 1 D c H HH DH H H D BH H D DH HH H D B H D U U U 02 6 1 oint Committee on Traceability in Laboratory Medicine
434. t in Japan evaluation of an IFCC reference material RPPHS CRM470 and establishment of reference intervals J Clin Lab Anal 1997 11 39 44 6 Baudner S Johnson AM Blirup Jensen S Whicher JT The certification of a matrix reference material for immunochemical measurement of 14 human serum proteins CRM470 in BCR information European commission 1992 00000 2004 33 2 0 27b 28b 8 00000000 00000000000000 0 171 1800 180000 U 20060 50000 9 Itoh Y Hosogaya S Kishi Preparation of a highly purified monomeric human albumin for standardization of urinary albumin immunoassay Urinary albumin measurement of NKDEP IFCC recommendations 2008 in press 10 Baudner S et al BCR information Reference materials Report Eur 15243 1993 10 ISO GUIDE 35 Certification of reference materials General and statistical principles 1989 132 UHHHN O00000 OU 5 S 000004000000 P AMY
435. testing data allows the effective use of the data in nationwide the improving medial treatment and consultation based on the data and the long term record of the individual clinical laboratory data It is the traceability that ensures the comparability among the clinical testing data obtained from different laboratories In this study several types of reference materials for laboratory medicine have been developed in order to establish the traceability Firstly about 20 kinds of matrix reference materials as secondary reference materials which are very important for diagnostic of first medication endocrine disease coronary disease diabetes and so on are going to be developed in 3 years In 2007 development of 20 matrix type of reference materials were carried out and 3 pure substance type of certified reference materials were investigated Among the matrix type of reference materials hemoglobin Alc HbAl1c was completed to be characterized by international collaborative experiment and to be estimated its uncertainty has already been nominated to the JCTLM Database In the case of 10 analytes such as glycoalbumin iron in serum urea cortisol insulin C peptide amylase in urine HDL cholesterol LDL cholesterol and C reactive protein CRP in serum we developed their prototype of matrix reference materials and investigated their response characteristics and comparability when they were used as traceability sources of routine measurement proce
436. using patient samples approved guidelines Document EP A ISBN 1 56238 283 7 1995 NCCLS Wayne PA 6 Passing H Bablok W J Clin Chem Clin Biochem 1983 21 709 20 1984 22 431 45 43 UHHH 0000 DU L 4 82 10 30 6000000000 70 9 00000000000000000000000000 0 00000000 70 201 0000000000000 70 000000 10 20 q 00 U 190000000000 00000000000000000 00000000000 OOOOO0000 70 Q 00 90000 200400 60000000 100 OO D uu 20000000 80000000 2007 9 23 O00000 20
437. y 0 6004x HECTEF PS1 a HECTEF PS1 y 0 5642x 8r A singo 0 53x 8 A Sindeo 7 DD HECTEF AS1 y 05874x 7 DD HECTEF AS1 y 0 5408x 6 00 HECTEF PS1 i 6 D HECTEF PSD E DD Sings D B 5 00 Ginden D r3 EV 4 3 2 2 lr 1 0 0 0 2 4 6 8 10 ED ID LC MSQHECTEF ED ID LC 382 14 2 FT40 0 ng d 10 9 HECTEF AS1 0 6468x m HECTEF PS1 8 A sioan y 0 5701x 7 HECTEF AS1 y 0 5381x 6 00 HECTEF PS1 g b 00 Singe 0 4 3 2 1 0 2 4 6 8 10 ED ID LC MSQHECTEF FTA ng d 10 9 HECTEF AS1 y 0 6812x m HECTEF PS1 8 A Sinde Fi 00 HECTEF AS1 y 0 4498x 6 HECTEF PS1 B i 00 Sings n 4 3 2 1 ie 0 ED ID LC MSQHECTEF FT40 ng d 10 9 HECTEF AS1 y 05619 m HECTEF PS1 8 A Sind y 0 5866x 7 HECTEF AS1 y 0 7071x 6 0 0 HECTEF PS1 H 5 L DD Ginden 0 EI Ea 3 2 1 0 0 2 4 6 10 ED ID LC MSQHECTEF FT40 ng d 10 9 HECTEF AS1 y 06272x m HECTEF PS1 8 A siggi 0 5135 7 51 y 04539 6 00 HECTEF PS1 E Ez e WWE Da Singe 0 E 8 EI 4 3 2 1 0 2 4 6 8 10 ED ID LC MSQHE

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