PDFファイル - 医薬品医療機器総合機構
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1. 000pg mL 3 OuL 3 CO 42. 5 2 0 H 3 2 H 3 3 1 UR 30
3. 1096 40 00pg mL Bis 1 1 996 500mg dL 00pg mL Bis 198 896 Bis pg mL _ B00mg dL 1600 lt 10 200 10 300mg mL 1000 lt 10 60mg dL 60mg dL gt Imtralipids 3000mg dL i Ua 600pg mL 1000pg mL 109 0mg dLI 6mg dL 8mg dL 100ng mL 5 3mg dL 6mg dL 3 3 4 1 3
4. 3mg dL mg dL 5mg dL 0 1mg dL 1mg dL G 5U mL 0 2mg dL 8mg dL 500mg dL 10mg dL mg dL 5mg dL 2 30mg dL 4mg dL 0 5mg dL 0 2mg dL 6 1ng mL 6g dL 6mg dL 12g dL 400mg dL 500IU mL 5mg dL 60mg dL 6mg dL 4mg dL 1mg dL 3000mg dL 3U mL 500mg dL 50mg dL 0mg dL G IgG 5g dL 50mg dL 1 2mg dL 10mg dL _ 500ng mL Bi OY 6 E
5. Bia Bs Bi 3 34 Be 1s i Ba 45pg mL 2100pg mL 4 2100pg mL 14 9
6. Bs I B 60pg mL i MM Biz 9 2 1355Da IF II TO H HC Bia Bis Bis DNA
7. Ue BON 0 Bis Be 80nm 612 nm Bs 1 EDTA 24 8C 48
8. I 2 1 1 8 8 200pg mL 1000pg mL 35Dg mL 60pg mL 9596 0g mL pg mL 00 429 199 986 199 3 182 6 5 g 78
9. Bi OE Bis 2 Bis Bis Bis 9 Bis EE IF HMS Bi
10. 7 pg mL 2 ne ACS Brs CLIA 1016 685 63 80 ECLIA 0 985 7 64 0 998 162 f CLSI NCCLS EP9 A2 Passing Bablok g 83 181 5pg mL CLIA 69 1829pg mL ECLIA x y pg mL n Vs 0 998 4 9 0 999 71 vs 0 991 0 999 71 a 0 88 1 0 998 7 CLSI NCCLS A p 1500 3 00 500 1000pg mL Bis Bis
11. 92 0 108 896 100 798 LoD LoB LoOD 28pg mL LoD CLSI EP1 7 A 3 5 5 120 3 596 8 596 LOB 18pg mL E LoB i 5 6Opg mL 5096CV LoQ 60pg mL 0 7pg mL WHO Standard 03 1 78 Bis World Health Organization International Standard 03 178 2 480pg mL 0 29 6 ua x 100 5 SE 1 HIV HBV HCV
12. 2 85 11596 3 3 CV 1 Oo m 8 6 CV9 6 pg mL Bio Rad LiquichekW Immunoassay Plus Control 1 AN 675 11 0 4 0 19 2 7 0 518 8 2 1 6 20 3 3 9 3 682 16 3 4 0 1 3 0 1 38 8 4 3 5 18 0 7 6 365 8 9 2 4 12 3 3 4 1007 14 4 1 4 1 0 2 1 3 1716 0 6 1 2 38 7 1 8 1500 e CLSI NCCLS EP5 A 1 20
13. 93 HIV HBV HCV a A ng AE EC 12 120 30 4 Ullman EF Kirakossian H Switchenko AC lshkanian J et al Luminescent oxygen channeling assay LOCR sensitive bro
14. Bi 11 12 b Bis LOCI Luminescent Oxygen Channeling Immunoassay PS Bis IF 1 Bs 2 SM
15. 48 0C 3 3 3 2 5 1 CLSI NCCLS EPZ7 A B
16. 3 Bs pg mL LOCI4 Vo TH 1 A 45 B 00 3 C 500 4 D 1000 5 E ON g mL 5 3 2 1 5
17. 500pg rmL 200pg mL B pg rmL LOCA4 V2 GS A 15uL 37C 38 3 AE 15uL 15uL 12uL 5OuL 50uL 3 680nm OE c
18. 8 1737 1742 Klee GG Cobalamin and Folate Evaluation Measurement of Methylmalonic Acid and Homocysteine vs Vitamin B12 and Folate Clin Chem 2000 46 8 B 1277 1283 Shenkin A Baines M Fell G S et al Vitamins and Trace Elements Tietz Textbook of Clinical Chemistry and Molecular Diagnostics Fourth Edition 2006 1100 1105 Tietz Clinical Guide to Laboratory Tests Fourth Edition 2006 1124 1127 Snow CF Laboratory Diagnosis of Vitamin B12 and Folate Deficiency Arch Intern Med 1999 159 1289 1298 Ward PCJ Modern Approaches to the Investigation of Vitamin B12 Deficiency Clin Lab Med 2002 22 435 445 Klee GG Cobalamin and Folate Evaluation i of Methylmalonic Acid and Homocysteine vs Vitamin B12 and Folate Clin Chem 2000 46 1277 1283 Ermens AAM Vlasveld LT Lindemans J Significance of Flevatede Cobalamin Vitamin B12 Levels in Blood Clin Biochem 2003 36 585 590 Clinical and Laboratory Standards Institute NCCLS Evaluation of Precision Performance of Quantitative Measurement Methods Approved Guideline Second Edition CLSIINCCLS document EP5 A2 ISBN 1 56238 542 9 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2004 Clinical and Laboratory Standards Institute NCCLS Method Comparison and Bias Estimation Using Patient Samples Approved Guideline Second Edition CLSIINCCLS document EP9 A2 ISBN 1 56238 472 4 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2002 Passing H Bablok W et
19. K6442A SIEM ENS 014 4 1 Oo6AAAMX00016000 B12 B12 L a 1 2 3 4 5 6 9 10
20. adly applicable homogeneous immunoassay method Clin Chem 1996 42 9 1518 1526 Ullman EF Kirakossian H Sharat S Ping Wu Z Irvin BR et al Luminescent oxygen channeling immunoassay Measurement of particle binding kinetics by chemiluminescenece Proc Natl Acad Sci USA 1994 91 5426 5430 Tietz Clinical Guide to Laboratory Tests Fourth Edition Alan H B Wu editor 2006 410 413 1124 1127 Clinical and Laboratory Standards Institute NCCLS Tubes and Additives for Venous Blood Specimen Collection Approved Standard Fifth Edition CLSIINCCLS document H1 A5 ISBN 1 56238 519 4 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2003 Clinical and Laboratory Standards Institute NCCLS Procedures for the Handling and Processing of Blood Specimens Approved Guideline Third Edition CLSI NCCLS document H18 A3 ISBN 1 56238 555 0 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2004 Clinical and Laboratory Standards Institute NCCLS Interference Testing in Clinical Chemistry Approved Guideline Second Edition CLSIINCCLS document EP7 A2 ISBN 1 56238 584 4 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2005 Kricka LJ Human anti animal antibody interference in immunological assay Clin Chem 1999 7 942 956 Vaidya HC Beatty BG Eliminating interference from heterophilic antibodies in a two site immunoassay for cretine kinase MB by using F D conjugate and polyclonal mouse IgG Clin Chem 1992 3
21. al A General Regression Procedure for Method Transformation J Clin Chem Clin Biochem 1998 26 783 790 Clinical and Laboratory Standards Institute NCCLS Protocols for Determination of Limts of Quantitation Approved Guidline CLSIINCCLS document EP17 A ISBN 1 56238 551 8 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2004 ow yy TEL 03 3493 8400 1 1 1 1 DL 111 315B 2012 12 07 D PN 782442 001 US
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