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1. 6 7 O W P S C QAAE T C2. HAMA Human Anti Mouse Antibodies HAMA 13 14 Carboxypeptidase G2 4 2 4 diamino 6 pteridinyD methyl methylamino benzoic acid DAMPA 15 16 17 0 00 1000 umol L 1000 pmol L
3. 5 g mL pmol L 2 2005 0 02 pmol L DNA 2
4. 4 8 1 1 24 2 1 Levey Jennings plot
5. Fluorescence Polarization Immunoassay FPIA 1 EDTA 1 2 10 20 mg dL 10 700 mg dL 5 0 86 g dL 5 8 g dL 5 1000 mg dL 5
6. 1 2 22 18 Mode 43 a EM A KEJ HH EE Eure b 3 4 5 6 CO 22 18 Mode 42 8 Mode 43 lt 0 05 Mode 43 3
7. MTX DILUTION PROTOCOL SAMPLES LOC CONC NETP BLKI 1 2 3 49 77 117 83 1310 59 4 CONCENTRATION 49 77 5 6 7 48 26 120 02 128848 8 CONCENTRATION 48 26 mol L NO VALID ANSWER 10 MTX DIL 1 1000 MTX ALL DILUTES 11 NO VALID ANSWER MODE 43 1 0 pmol L Mode 43
8. TDX HPLC 0 02 1000 pmol L MODE 43 MODE 42 TDX 11 3 VS TDX 0 02 1 0 pmol L 49 0 02 0 93 0 989 TDX 0 02 1000 pmol L 93 TOA 0 95 MD HPLC 0 03 1000 pmol L 95 0 02 1 01 0 999 2 USP Grade 1 WE
9. l 4 6 50 mg m2 15 g m 24 5 10 mol L 48 0 5 1 0 pmol L 72 0 2 mol L 3 5 6 7 9 10 12
10. NO VALID ANSWER 10 NO VALID ANSWER a 1 1 1 0jumol L 1 10 0 9 mol L b 1 10 10 0 pmol L 1 100 9 0 pmol L c 1 100 100 pmol L 1 1000 90 0 y mol L d 1 1000 1000 pmol L TDX MODE 42 mol L 0 0 1 1 1
11. w BAA 4 M READY 2 3 2H m MODE 42 80 pL 42 1 1 80 pL 1 10 50 pL 1 1
12. La i 1 21 22 METHOTREXATE 22 1 SPL VOL 10 0 222 SPL REP 1 22 3 LOLIM 0 00 224 HILIM 1000 00 22 5 CAL VOL 10 0 22 6 CAL REP 2 22 7 CONC A 0 00 22 8 CONC B 0 05 22 9 CONC C 0 15 22 10 CONCD 0 30 22 11 CONCE 0 60 22 12 CONCF 1 00 22 13 UNITS 2 22 14 CRV FIT 2 22 15 MX DEV 5 0 22 16 MN POLA m 22 17 MN SPAN 22 18 MODE 42 22 19 GAIN 22 20 MX BKG 2500 00 22 21 MN TR 1 2 Mi 3 DEU
13. 3 1000 pmol L 50gL Mode 43 0 1 0 pmol L Mode 42 1 10 1 100 1 1000 80uL Mode 42 1 1 Mode 42 MODE 42 Mode 42 1 2 1 4 TDX 3 4 1 4 TDX 1 5 9 13 17 80pL 5 Z 6 7 6 EUM METHOTRE
14. mol L A 0 00 B 0 05 C 0 15 D 0 30 E 0 60 F 1 00 II Methotrexate II Controls 7A12 10 2 5 mL 6 ymol L rmol L E 0 07 0 04 010 M 0 40 0 34 0 46 H 0 80 0 67 0 93 X 5 00 4 00 6 00 Y 50 00 37 20 62 80 Z 500 00 369 19 630 81 TDX 9519 TDX TDX 3 D 2 P S T KO EUH CERRO DERUE L V mp be 510 560 nm 3 mp p mp T I ctlIr I
15. TDX MX BKC BLKT HI 1 95 0 02 mol L 2 0 07 0 40 0 80 5 50 500 mol L National Committee for Clinical Laboratory Standards NCCLS EP5 T218 M H X Y Z CV 96 10
16. HIV HBV HCV OSHA Standard on Bloodborne Pathogens19 220 2122 HIV 1 l
17. 1000 mol L 1 DL L 5 6 DL N 5 DL 6 5 6 7 8 3 TDX TDXFLX 1 2 TDX 16 0 TDXFLX 3 0 1 Methotrexate II Calibrators 7A12 01 2 5 mL 6
18. a PERR Polarization Error 4 00 4 00 b RMSE Root Mean Squared Error 3 00 c Board 2 PERR RMSE
19. 25 PER 2 8 C 20 II H O 7A12 86 100 WEO 4mL 1 WKO 3 5 mL 1 40mL 1 35mL 1 1 Tietz NW Finley PR Pruden EL eds Clinical guide to laboratory tests 2nd Edition Philadelphia PA W B Saunders
20. 2 8 5 3 HIV HBV 2 1 n 1 000 ppm 1 HCV 121YC 20 Pii IET 0 1 BUS C 6
21. 80 pL 0 9 10 LSIG 50uL 9 0 100 1 100 50uL 90 0 1000 1 1000 50uL Mode 42 1 2 1 4 TDX 3 4 1 4 TDX 1 5 9 13 17 5 M 1 10 X 1 100 Y 1 1000 Z 6 7 8 a TDXFLX 13 CALIBRATION
22. TDX CALIBRATION b DEN t CAROUSEL e BAA t d DIA MTX DIL 1 1 MTX DIL 1 10 MTX DIL 1 100 MTX DIL 1 1000 e Hil E 3 Sq dosn o EB 1 1 9 rmolL 4 1 4 5 8 9 12 13 16 17 20
23. DA A Carl 7 E MELA E fv REO 1000 pmol L DAMPA 5mol L 5 mol L boxypeptidase G2 26 1000 pmol L 59
24. HBs HIV 1 RNA HCV HIV 1 HIV 2 ek 2
25. L CV 96 15 n 80 0 07 0 40 0 80 5 50 500 umol L 0 07 040 083 504 49 81 495 16 n SD 0 005 0 006 0 012 0 17 1 12 12 97 1 CV 79 1 5 1 5 3 4 2 3 2 6 SD 0 007 0 018 0 042 0 22 1 57 19 04 Egg CV 10 3 4 5 51 4 4 32 3 8 SD 0 009 0 022 0 049 0 28 2 92 27 02 i V CV 96 14 0 5 4 59 5 6 5 9 5 5 3 0 15 0 30 0 60 mol L l 5 EST NE ume EIE pmol L 0 15 0 14 0 14 100 00 0 30 0 29 0 28 103 57 0 60 0 55 0 57 96 49 Miss oe 100 4 0 02 1000 pmol L 5 1
26. 00 50 pL 1 1000 50 pL 43 50uL lt 1 0 pmol L 0 00 1 00 mol L 1 22 18 MODE Mode 42 Mode 43 Mode 43 Mode 42 Mode 2 L M H Mode 43 M X Y Z Mode 42
27. 469399 R9 2011 5 3 hi 2009 10 2 hi 20600AMY00146000 II 1 2 3 4 5
28. Company 1990 724 2 Young RC Chabner BA An in vivo method for monitoring differential effects of chemotherapy on target tissues in animals and man Correlation with plasma pharmacokinetics J Clin Invest 1973 52 6 abstract 340 92a 3 Crom WR Evans WE Methotrexate In Evans WE Schentag JJ Jusko WJ eds Applied Pharmacokinetics Principles of Therapeutic Drug Monitoring Vancouver WA Applied Therapeutics Inc 1992 29 1 to 29 42 4 Nirenberg A Mosende C Mehta BM Gisolfi AL Rosen G High dose methotrexate with citrovorum factor rescue Predictive value of serum methotrexate concentrations and corrective measures to avert toxicity Cancer Treat Rep 1977 61 5 779 83 5 Djerassi I et al New Rescue with massive doses of citrovorum factor for potentially lethal methotrexate toxicity Cancer Treat Rep 1977 61 4 749 50 6 Jaffe N Traggis D Toxicity of high dose methotrexate NSC 740 and citrovorum factor NSC 3590 in osteogenic sarcoma Cancer Chemother Rep 1975 6 1 31 6 7 Chan H Evans WE Pratt CB Recovery from toxicity associated with high dose methotrexate Prognostic factors Cancer Treat Rep 1977 61 5 797 804 8 Von Hoff DD et al Incidence of drug related deaths secondary to high dose methotrexate and citrovorum factor administration Cancer Treat Rep 1977 61 4 745 8 9 Mazanec DJ Grisanti JM Drug induced osteoporosis Cleve Clin J of Med 1989 56 297 303 0 Chessells J
29. M et al Neurotoxicity in lymphoblastic leukaemia Comparison of oral and intramuscular methotrexate and two doses of radiation Archives of Disease in Childhood 1990 65 416 22 1 Allen JC Rosen G Mehta BM Horten B Leukoencephalopathy following high dose Iv methotrexate chemotherapy with leucovorin rescue Cancer Treat Rep 1980 64 12 1261 73 2 Jacobs P Rutherford GS King HS Vincent M Methotrexate encephalopathy Eur J Cancer 1991 27 8 1061 2 3 Primus FJ Kelley EA Hansen HJ Goldenberg DM Sandwich type immunoassay of carcinoembryonic antigen in patients receiving murine monoclonal antibodies for diagnosis and therapy Clin Chem 1988 34 2 261 4 4 Schroff RW Foon KA Beatty SM Oldham RK Morgan Jr AC Human anti murine immunoglobulin responses in patients receiving monoclonal antibody therapy Cancer Research 1985 45 879 85 5 Chabner BA Johns DG Bertino JR Enzymatic cleavage of methotrexate provides a method for prevention of drug toxicity Nature 1972 239 5372 395 7 6 Widemann BC et al Carboxypeptidase G2 rescue in a patient with high dose methotrexate induced nephrotoxicity Cancer 1995 76 3 521 6 7 Buchen S et al Carboxypeptidase G2 rescue in patients with methotrexate intoxication and renal failure British Journal of Cancer 2005 92 3 1 8 8 Kennedy JW et al Evaluation of precision performance of clinical chemistry devices National Committee for Clinical Laboratory St
30. XATE MTX DIL PROTOCOL 9 10 100 1000 fX 0 3 pmol L MTX DILUTION PROTOCOL SAMPLES LOC CONC NETP BLKI 1 0 41 131 61 1565 44 2 198 58 1345 23 3 206 33 1317 02 4 205 67 1364 18 CONCENTRATION 0 4199 5 0 79 80 20 1606 90 6 190 21 1365 22 7 203 98 1320 76 8 205 17 1420 02 CONCENTRATION 0 79 9 316 1648 31 10 4 83 120 01 1391 27 11 194 24 1324 50 12 203 98 1303 91 CONCENTRATION 4 83 jrmol L
31. andards NCCLS 1992 12 4 19 US Department of Labor Occupational Safety and Health Administration 29 CFR Part 1910 1030 Bloodborne pathogens 20 US Department of Health and Human Services Biosafety in Microbiological and Biomedical Laboratories 5th ed Washington DC US Government Printing Office January 2007 21 World Health Organization Laboratory Biosafety Manual 3rd ed Geneva World Health Organization 2004 22 Clinical and Laboratory Standards Institute Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition CLSI Document M29 A3 Wayne PA Clinical and Laboratory Standards Institute 2005 Borsi JD Sagen E Romslo I Moe PJ Comparative study on the pharmacokinetics of 7 hydroxymethotrexate after administration of methotrexate in the dose range of 0 5 33 6 g m to children with acute lymphoblastic leukemia Medical and Pediatric Oncology 1990 18 217 24 Borsi JD Sagen E Romslo I Slordal L Moe PJ 7 Hydroxymethotrexate concentrations in serum and cerebrospinal fluid of children with acute lymphoblastic leukemia Cancer Chemother Pharmacol 1990 27 164 7 Physicians Desk Reference A7th Edition Montvale NJ Medical Economics Co Inc 1993 Wolfrom C Hepp R Hartmann R Breithaupt H Henze G Pharmacokinetic study of methotrexate folinic acid and their serum metabolites in children treated with high dose m
32. ethotrexate and leucovorin rescue Eur J Clin Pharmacol 1990 39 377 83 270 2214 278 TEL 0120 031441 F 270 2214 278 TEL 047 385 2211 ABBOTT JAPAN CO LTD 2011 c Abbott
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