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1. H317 P261
2. 10 75 gL 25 pL 3 150 gL 25 pL
3. IgM
4. UgG CMV IgM RF IgG CMV IgM IgG CMV vitro
5. OSHA Standard on Bloodborne Pathogens 2 47 1 IgM CMV HBs HIV 1 HIV 1 RNA HIV 1 HIV 2 HCV IgM CMV HBs HIV 1 HIV 1 RNA HIV 1 HIV 2 HCV
6. 1 Index Index HAMA Human Anti Mouse Antibodies MA HAMA Index 1 00 mdex 0 500 2 3 RP 019 1 0 26 0 188 Profile 5 0 24
7. 30 2
8. 10 000 RCF 10 5 6
9. Eis i 8 TRIS ProClin 300 0 166
10. 3 4 1 3 1 30
11. 30 2 8 2 8 2 8 3 HIV HBV HCV 1 000 ppm 1 2 1
12. 2 8C 2 8 30 30 2 8 2 8
13. 3 1 2 3 10 4
14. 5 24 1 6 1 3 1
15. 3 4 4
16. a TgM CMV 0 80003 2 20 mg dL 3000 mg dL 4 5 12 g dL 0 4 v v 500 mg dL CLIA a Se 1 2 EB RR 6 B19 IgM JgC 1 IgG CMV 351
17. 270 2214 278 TEL 0120 031441 270 2214 278 TEL 047 385 2211 ABBOTT JAPAN CO LTD 2015 EC Abbott
18. 2 8 2 8 2 30 12 12 18 CMV M 6C16 26 100 6 6mLX1 5 9 mL Xx 1 10 0 mL Xx 1 6C16 36 500 27 0 mL Xx 1 26 3 mL x 1 50 9 mL Xx 1 6E23 975 mL X 4 6C55 975 mL x4 1 2 Boscato LM Stuart MC Heterophiic antibodies a problem f
19. DNA 9 1 A B 8 A B 1 7 DNA 9 2 1 HIV HBV HCV
20. ARCHITECT CMVIM ARCHITECT CMV IgM Calibrator 6C16 01 4 0mLX 1 1 ProClin 950 1 IgM CMV Index S CO 1 1 00 ARCHITECT CMVIM ARCHITECT CMV IgM Controls 6C16 10 4 0mLX2 ProClm 950 ProClm 950 IgM CMV Index S CO Index S CO N A 0 0 60
21. 1 500 CMV IgM 6 541_006 2
22. Pe 95 44 335 351 95 92 70 16 3 9 4 Ll 3 0 9 ARCHITECT TBA EDTA I i 1 2
23. P272 P280 P302 P352 P333 P313 P362 P364 P501 H317 EUH032 P261 P272 P280 P302 P352
24. 2 30 1 15 3 45 3 1 25 pL 225 gL 2 1 10 gL 90 pL 50 pL 3 50 kL 4 100 gL 5 300 gL 400 500 nm 6 Index Index
25. P333 P313 P362 P364 P501 SDS 2 3
26. Index S CO TImndex S CO Index 0 85 IgM CMV Index 1 00 IgM CMV Index 0 85 1 00 Index 0 85 Index 1 00 2
27. 1085 Inc 1 6 88 24 3 i a 17 3 09 0 187 a 84 5 29 1 655 95 95 32 4 87 1 962 51 4 50 1 527 99 63 97 95 98 88 96 78 67 4 07 1 597 268 269 266 269 RE 003 1 160 0205 100 00 97 52 97 96 94 15 Profle 4 4 71 0 982 A MA Diagnostics 99 30 97 49 96 84 94 09 iagnostics 8 5 70 2 896 283 285 276 285 51 174 0 732 99 44 9801 95 83 93 22 55 1 44 0 808 358 360 345 360 59 1 29 0 616 99 53 98 90 97 17 95 99 65 120 0 739 1056 1061 1031 1061 67 1 18 0 668 72 1 08 0 622 74 1 05 0 652 9 1 07
28. 121 20 0 1
29. 0 121 Diagnostics 8 0 25 0 143 1 12 0 27 0 148 CV10 15 0 24 0 123 Clinical and Laboratory Standards Institute CLSD 21 0 35 0 294 1 3 26 0 41 0 214 1 2 2 29 0 99 0 168 5 1 2 5 33 4 22 0 670 36 6 30 1 433 SD CV SD CV n RLU RLU RLU RLU RLU 00 0 2 MM 1 500 2853 1087 38 108 7 38 nM 6 06 2 094 57 5 30 1 909 68 4 11 1 389 SD CV SD CV 75 3 68 1 160 n Index Index Index Index Index 1500 0 14 0010 688
30. 0 593 A 84 1 07 0 710 88 1 15 0 846 4 1 05 0679 IgM CMV 99 1 02 0 698 5 1 A n 190 99 2 131 132 84 5 49 58 94 7 180 190 A 49 1 50 9 131 140 58 132 190 B n 184 99 2 126 127 84 2 48 57 94 6 174 184 B 48 49 9 126 135 57 127 184 A B
31. S Com 0 ee 4 3 2 8 TRIS lg ProClin 950 2 8 14 14 10 6 7
32. 47 0303 R04 2015 7 2 gt 500 mg dL 2015 2 1 22700AMX00131000 M CMV M 1
33. 5 0010 6 885 92 298 0 0 933 MM 1500 254 0083 3265 0085 3328 86 3 19 1 099 89 2 87 0 830 96 2 66 0 864 104 2 50 0 691 109 2 24 0 647 2 3 0 0 3 1 2 66 0 886 121 2 12 0 635 Gindex ndeo 18 9 670 2 mdex 1 00 ndex 0 500 PTC901 015 0171 3 Boston Biomedica 0 12 0 145 A
34. or all immunoassays Clin Chem 1988 34 1 27 33 Primus F Kelley EA Hansen HJ et al Sandwich type immunoassay of carcinoembryonic antigen in patients receiving murine monoclonal antibodies for dagnosis and therapy Clin Chem 1988 34 2 261 264 Schroff RW Foon KA Beatty SM et al Human anti murine immunoglobulin responses in patients receiving monoclonal antibody therapy Cancer Res 1985 45 2 879 885 US Department of Labor Occupational Safety and Health Administration 29 CFR Part 1910 1030 Bloodborne pathogens US Department of Health and Human Services Biosafety in Microbiological and Biomedical Laboratories 5th ed Washington DC US Government Printing Office December 2009 World Health Organization Laboratory Biosafety Manual 3rd ed Geneva World Health Organization 2004 Clinical and Laboratory Standards Institute CLSI Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition CLSI Document M29 A3 Wayne PA CLSI 2005 ARCHITECT 5 468 646 5 543 524 5 545 739 5 565 570 5 669 819 5 783 699
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