PDFファイル - 医薬品医療機器総合機構
Contents
1.2. 10 70 1 20 kL 3 150pL
3. g mL pmol L gmol L ug mL x 4 31 pmol L 2
4. 30 2
5. CLIA 1 EDTA EDTA
6. 6 T O TRIS ProClin 300 MES ProClin 300 O X
7. 2 100 10 Clinical and Laboratory Standards Institute CLSI H NCCLS EP7 A2 15g mL 40 g mL 92 1 101 296 2500 mg dL 500 mg dL 15 mg dL 3 g dL 10 g dL X
8. 80 00 pg mL gt 80 00 10 10 uL 90 uL A A B C D E F 2 1
9. 2SD 1 10 rg mL LoB LoD LoB LoD CLSI EP17 A Ca 5 Rmi ARE CB 5 1 60 5 15 LoB 0 15 pg mL LoD 0 34 ug mL X 5 1 10 80 00 ug mL 6 1 1 00 0 15 0 95 Passing Bablok
10. n e 2 8 AA 100 2 8 S M 2 8C 2 8 E 9 860 5 10 2 8 3 HIV HBV HCV
11. 98 15 40 kk g mL 3
12. 1 HIV HBV HCV OR 120 dune MED DE uM CT z 7E GHH BODIE C RIDE
13. HAMA Human Anti Mouse Antibodies 1911 HAMA po IAEOv cimo E 1 CV10 CLSI EP5 A213
14. 1 000 ppm 1 LUN DECUS 9 2 1 ug ml 121 20 EAN 2 USP Reference Standard Phenobarbital 0 1
15. 0 0 80 0 pg mL 24 1
16. 3 100 10 3 3 A pg mL 9 76 88 1 1 4 19 69 102 4 1 10 8 32 108 2 1 40 2 28 118 8 77 82 2 1 4 19 31 99 2 1 10 7 98 102 5 1 40 2 13 109 5 77 83 3 1 4 20 30 104 3 1 10 8 03 103 2 1 40 2 14 109 8 106 496 ug mL JS TA 76 09 1 1 4 18 65 98 0 1 10 7 69 101 1 1 40 2 00 105 1 78 36 2 1 4 19 31 98 6 1 10 8 07 103 0 1 40 2 17 111 0 73 68 3 1 4 20 16 109 4 1 10 7 82 106 1 1 40 2 18 118 2 105 6 a REE ug mL x x 100 ug mL 4
17. 10 2 2 8C 8 20 6
18. 6 4PLC w f l 3 4
19. 1 2 3 3 3 3 20 1 2 2 1 n gm SD CV SD CV 1 1 80 937 031 3831 034 3963 1 2 2 80 926 032 346 036 3389 3 3 80 940 024 255 033 351 1 1 80 2359 0372 8305 082 348 2 2 2 80 2334 073 313 101 433 3 3 80 2411 063 261 070 290 1 1 80 4730 121 256 152 321 LAM3 2 2 80 4851 138 2 84 148 305 3 3 80 4887 128 262 145 297 1 1 80 9 64 032 332 033 342 1 2 2 80 946 027 285 035 3 70 3 3 80 9 668 027 279 032 331 1 1 80 3715 097 261 122 328 2 2 2 80 3736 106 284 141 377 3 3 80 3875 113 292 128 330 1 1 80 5621 152 270 209 372 3 2 2 80 5776 244 422 265 459 3 3 80 5732 158 276 200 349
20. 1 204L 2 A 5 150pL
21. K 20 Pret gg M as 0 10 20 30 40 50 60 70 80 FF ug mL Xe 1 E Pu X ne PF 132 1 42 71 65 n g mL PEILI x 775
22. S35 S37 CE 1 10 qb 12 13 14 15 16 17 18 19 Guder WG da Fonseca Wollheim F Heil W et al The Quality of Diagnostic Samples Darmstadt Germany GIT Verlag 2001 40 1 Clinical and Laboratory Standards Institute Interference Testing in Clinical Chemistry Approved Guideline Second Edition CLSI document EP7 A2 Wayne PA Clinical and Laboratory Standards Institute 2005 Buchthal F Svensmark O Aspects of the pharmacology of phenytoin Dilantin and phenobarbital relevant to their dosage in the treatment of epilepsy Epilepsia 1960 1 373 84 Butler TC Mahaffee C Waddell WJ Phenobarbital studies of elimination accumulation tolerance and dosage schedules J Pharmacol Exp Ther 1954 111 425 35 Svensmark O Buchthal F Accumulation of phenobarbital in man Epilepsia 1963 4 199 206 McGeachy TE Bloomer WE The phenobarbital sensitivity syndrom
23. 3 1 10 kL 50kL 50 kL 2 100pL 3 300 kL 400 500nm 4 5 1 4 1 ARCHITECT 7 CD ROM Addition C SZ
24. HAMA RF 100 10 HAMA 5 RF 5 15 ug mL 40 pg mL HAMA 97 0 100 1 RF 99 3 99 6 15 ug mL 40 pg mL 0 2 5 5 21 9 10096 ug ml
25. 2 8 2 8 1 10 78 25 u g mL 2 8 1 95 23 9 7 7 30 10 40 p g mL PEALT x 7 JVC A JV T1 ZACASU DRE 5 30 8 7 95 18 9 1 5
26. F5 0204 1 R2 2010 1 2 2008 10 1 12A2X00009000026 sr 1 2 3 4 5
27. 25 30 00 00 00 10 11 240 00 00 00 300 5 5 200 p 22 20 15 150 100 300 u g mL 200 25 100 a 3 ARCHITECT TBA 1 2
28. 3 3 5 1 2 2 1 n ugmD SD CV SD CV 1 1 20 76 98 1 40 1 82 1 93 2 51 2 2 20 71 18 2 18 3 06 2 93 4 11 3 3 20 175 07 3 03 4 04 3 09 4 12 2 100 10 5 5 16 40 60 kxg mL 94 99 95 100 97 0 8
29. ARCHITECT i CD ROM Addition C ARCHITECT ARCHITECT Phenobarbital Calibrators 1P33 01 4mL 6 HBs HIV 1 RNA HIV 1 HCV HCV RNA HIV 1 HIV 2 pg mL mg L un pmol L CAL A 0 0 0 0 CAL B 5 0 21 6 CAL C 10 0 43 1 CAL D 20 0 86 2 CAL E 40 0 172 4 CAL F 80 0 344 8 Abbott Immunoassay MCC Liquid 6E20 10 HBs HCV HTV 1 HIV 2
30. dax 95 95 0 93 0 44 132 0 91 0 95 0 80 0 18 1 0 142 71 65 pg mL PELLI x 7 2 NVCAMV 44027 1 10 78 25 u g mL a 2 vs ZZ 80 70 o T B p 3 n g eoe P BUEGR ULAHE EDEOIRGURNCCERUOHU BUEOSERDS CTebid Ge po
31. 2 8 OSHA Standard on 2 8 Bloodborne Pathogens 2 30 217 18 1819 12 18 sr
32. O 1P33 26 100 E G6mL 1 9 mL 1 is TE 2s E Mey i s COE ees EH ProClin EU Xi R S
33. e Am Med 1953 14 600 4 Dent CE Richens A Rowe DJE et al Osteomalacia with long term anticonvulsant therapy in epilepsy Br Med J 1970 4 69 72 Hawkins CF Meynell MJ Macrocytosis and megaloblastic anemia in epileptics on anticonvulsant drugs Q J Med 1956 25 100 567 8 Buchthal F Svensmark O Serum concentrations of diphenylhydantoin Phenytoin and phenobarbital and their relation to therapeutic and toxic effects Psychiatr Neurol Neurochir 1971 74 117 36 Schroff RW Foon KA Beatty SM et al Human anti murine immunoglobulin responses in patients receiving monoclonal antibody Primus FJ Kelley EA Hansen HJ et herapy Cancer Res 1985 45 879 85 al Sandwich type immunoassay of carcinoembryonic antigen in patients receiving murine monoclonal antibodies for diagnosis and therapy Clin Chem 1988 34 2 261 4 Boscato LM Stuart MC Heterophilic ani ibodies A problem for all immunoassays Clin Chem 1988 34 1 27 33 National Committee for Clinical Laboratory Standards Evaluation of Precision Performance of Quantitative Measurement Methods Approved Guideline Second Edition NCCLS document EP5 A2 Wayne PA NCCLS 2004 National Committee for Clinical Laboratory Standards Protocols for Determination of Limits of Detection and Limits of Quantitation Approved Guideline NCCLS document EP17 A Wayne PA NCCLS 2004 Passing H Bablok W A new biometrical procedure for testing the equality of measurements from
34. two different analytical methods J Clin Chem Clin Biochem 1983 21 11 709 20 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 January 2007 World Health Organization Laboratory Biosafety Manual 3rd ed Geneva World Health Organization 2004 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 270 2214 278 TEL 0120 031441 T 270 2214 278 TEL 047 385 2211 COABBOTT JAPAN CO LTD 2010 c Abbott
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