QMS® Tacrolimus Immunoassay
Contents
1. pe dei qe2. N JJ 2 8 C 32 C N
3. 3 200 uL No IE 4 15 30 A np ea E ME ES p 5 TEENS 5 7 6 15 000 16 000 xg RPM 5
4. A FDA HIV1 HIV2 B C a CECI U 0 09 SDS EDTA
5. AMS 700 nm QMS REF 10015556 3
6. 2 lt 8 7 20 6 nMS REF 10015556 OMS REF 10015573 CAL A 1 x 4 mL CAL B F 1x2mL e MORE Diagnostics Rap Tac CsA Controls amp 280 0 4x4mL FH 280 1 4x 4mL f 280 2 4x4 mL iac Thermo Fisher Scientific 7 7 Z Cn
7. 0MS 00 QMS 2 EO ta LGG sse 23 3 9 3 7 M Ms0 53 80 n2 38 35 6 7 184 17 M IV 12 m 50 6t 720 57 m3 m0 1 5 5 M VIl 8080 2777 20 4 7 1097 67 M VII 1315 0 M VI 13 31 0 20 134 13 8 103 0 2 0 96 x 100 M IV 174 8
8. 1 ng mL x CALA 6 VES QMS 47H A B C D E F 0MS tcu 0QMS QMS REF 10015573 1
9. MMF MPAJ 95 CI 95 CI R 1 111 0 53 1 130 0 71 1 092 1 167 0 42 1 01 id 1 126 0 03 208 1 071 1 181 0 63 0 56 Vus QMS 1 0 30 8 ng mL LC MS MS 0 8 29 5 ng mL ARCHITECT 2 4 28 1 ng mL Abbott ARCHITECT CI 0MS QMS LC MS MS 1 Abbott ARCHITECT OMS LC MS MS 1 OMS ARCHITECT E 3 8 X v 3 LI HI SN D DW I 0 5 10 15 20 25 30 p 10 15 20 25 30 LC MS MS 1 ng mL ARCHITECT 4 ng
10. ERN d cem 1 1 des Beckman AU680 NSH Thermo Fisher Scientific AMS 1 ng mL 30 ng mL 20 CV 0 5 5 0 ng mL
11. AE e 1 e c lu I MTERA LTE WEBDRRYTET ZEFELTU RA BWER
12. FKBPs FK506 FKBP A B IL 2 35 12 67 P 450 CYP3A 8 M I M VIII 48
13. IREAGENT 1 1x 18 mL REAGENT 2 1 x 12 mL 1 x 50 mL 2 INGRED 1 0 FIF REUS 0 0996 0 3 0 09 EXT 0 09 REAGENT 1 REAGENT 2 EXT 1
14. Ok E LAE COS 1 e Uy OMS ng mL 0OMs
15. 1 1 2 30 60 7 zh 95 LoQ 0 9 ng mL 0 102 0 0MS A E WV ren EiBSHHO 102 9 100 4 sm wm mn me ng mL ng mL Aum o wo 09 Los on 4 3 WA 96 x 96 x 100 LC MS MS QMS
16. 100 000 Ip T SE 5 ELM P ordi 100 2509 1 000 000 150 000 100 000 100 000 120 000 100 000 A 100 000 QMS 92 108 12 64 ANS BE US m HAMA f4 ON Yl dB o EEE co o c N o i E E pa P x gr CN TA D 1 2 d mn CE 1 Kino T Hatanaka H Miyata S et al FK 506 a novel immunosuppressant isolated from a streptomyces ll Immunosuppressive effect of FK 506 in vitro J Antibiotics 1987 40 1256 1265 2 Bierer BE Jin YJ Fruman DA et al FK506 and rapamycin molecular probes of T lymphocyte a
17. 50 000 17 100 150 000 100 000 B 100 000 D 3 07 Ix 35 000 F e 100000 20 000 hi o BS II 100000 100000 100 000 60 000 100 000 100 000 ow 100 000 5000 8 000 120 000 i dd d 120 000 VZHHEZUTTI 2 7 HE gw C 50 000 20 000 250 000 100 000 100 100 000 N90 100 000 1 200 100 000 10 000 A 600 000 TUA 200 000 100 000 300 000 500 000 n 10 000 100 000 100000
18. 7 8 OMS Thermo Fisher Scientific 7 EE QMS CALA 0 0 ng mL 30 ng mL OMS CALA 0 0 ng ml 1 1
19. M V M VIlI M 6 M I 915 M II 6 M IV CLSI EP7 A2 Lc 0MS 5 12 ng mL 0MS 10 91 109 ngn gin BEE iwopo 100 000
20. 15 20 ma hal 10 mL ur eh 99 896 40 mL 2 1 1 2 200 uL
21. J Cda Hj HE me THE CENE mes HH Ja mu HU C HHi m wa o 9 ama m me as ms HHs m ms m me 96 x 100 CLSI EP5 A2 2 1 2 20 SD CV zh ELCHE A 80 30 RODEO B m DUIS C 0MS 2 LC MS MS E 1 2 Abbott ARCHITECT EDTA 9
22. Wu i uA E S MES QOMS NN AMA
23. OMS Tacrolimus Immunoassay 10015556 MS 0MS Bi FK506 T
24. across ethnic groups Clin Pharmacol Ther 2001 69 24 31 iud Authorized Representative in E U Microgenics Corporation Microgenics GmbH 46500 Kato Road C Spitalhofstrasse 94 Fremont CA 94538 USA D 94032 Passau Germany 800 626 0690 Tel 49 0 851 886 89 0 Fax 449 0 851 886 89 10 1 800 232 3342 Microgenics Bio Rad Lyphocheck Bio Rad MORE Diagnostics Controls MORE Diagnostics Inc ARCHITECT Abbott Laboratories Thermo Fisher Scientific Inc 2014 Thermo Fisher Scientific Inc All rights reserved CR www thermoscientific com diagnostics 10015557 4 JA Thermo 2014 08 SCIENTIFIC
25. ctivation Transplant Proc 1991 23 2850 2855 3 Schreiber SL Chemistry and biology of the immunophilins and their immunosuppressive ligands Science 1991 251 283 287 4 Thomson AW Bonham CA and Zeevi A Mode of action of tacrolimus FK506 molecular and cellular mechanisms Ther Drug Monit 1995 17 584 591 5 Griffith JP Kim JL Kim EE et al X ray structure of calcineurin inhibited by the immunophilin immunosuppressant FKBP12 FK506 complex Cell 1995 82 507 522 6 Jusko WJ Thomson AW Fung J et al Consensus document therapeutic monitoring of tacrolimus FK 506 Ther Drug Monit 1995 17 606 614 7 Physicians Desk Reference 58th ed Thomson PDR at Montvale NJ 2004 PROGRAFS 1323 1327 8 Lhoest GJ Maton N Latinne D et al 15 desmethyl FK 506 and 15 31 desmethyl FK 506 from human liver microsomes isolation identification by fast atom bombardment mass spectrometry and NMR and evaluation of in vitro immunosuppressive activity Clin chem 1994 40 740 744 9 Gonschior AK Christians U Winkler M et al Tacrolimus FK506 metabolite patterns in blood from liver and kidney transplant patients Clin Chem 1996 42 1426 1432 10 Alak AM Measurement of tacrolimus FK506 and its metabolites a review of assay development and application in therapeutic drug monitoring and pharmacokinetic studies Ther Drug Monit 1997 19 338 351 11 Jusko WJ Analysis of tacrolimus FK506 in relation to therapeutic drug monitoring Ther Dru
26. g Monit 1995 17 596 601 12 Christians U Pokaiyavanichkul T Chan L Tacrolimus Applied Pharmacokinetics and Pharmacodynamics Principals of Therapeutic Drug Monitoring 4th Edition Lippincott Williams amp Wilkins Philadelphia PA 2005 529 562 13 Staatz CE Willis C Taylor PJ and Tett SE Population pharmacokinetics of tacrolimus in adult kidney transplant recipients Clin Pharmacol Ther 2002 72 660 669 14 PROGRAF package insert Deerfield IL Astellas Pharma US Inc 2012 15 Tholen DW Kallner A Kennedy JW et al NCCLS Evaluation of Precision Performance of Quantative Measurement Methods Approved Guideline Second Edition NCCLS document EP5 A2 ISBN 1 56238 542 9 NCCLS Wayne PA 2004 16 Deming WE Statistical adjustment of data New York Wiley 1943 Dover Publications edition 1985 Dover Publications New York 17 Bland JM Altman DG Statistical methods for assessing agreement between two methods of clinical measurement Lancet 327 8476 1986 307 310 18 McEnroe RJ Burritt MF Powers DM et al Clinical and Laboratory Standards Institute Interference Testing in Clinical Chemistry Approved Guideline Second Edition CLSI document EP7 A2 ISBN 1 56238 584 4 Clinical and Laboratory Standards Institute Wayne PA 2005 19 Mancinelli LM Frassetto L Floren LC Dressler D Carrier S Bekersky Benet L and Christians U The pharmacokinetics and metabolic disposition of tacrolimus A comparison
27. mL 0MS QMS LC MS MS 1 Bland Altman Abbott ARCHITECT Bland Altman QMS LC MS MS QMS 1 ARCHITECT A OMS LC MS MS QMS ARCHITECT QMS LC MS MS 1 ng mL 0MS ARCHITECT ng mL 0 5 10 15 20 25 30 0 5 10 15 20 25 30 LC MS MS 1 QMS ng mL ARCHITECT 4 QMS ng mL CLSI EP7 A2
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