ISO15189临床免疫学应用指南（许斌）

ISO15189 xubin@jsccl.com www.jsccl.com 1 2 - / / 3.1 detection limit/limit of detection 3.2 cut-off value 3.3 analytical sensitivity 3.4 analytical specificity 3.5 calibrator [ISO 18113-1, 3.11] 3.6 diagnostic sensitivity 3.7 diagnostic specificity 3.8 3.9 3.10 3.11 5.1 5.1.2 HIV 5.1.4 2 3 5.1.10 5.1.11 2 2 30 5.1.13 5.2 5.2.1 5.2.2 5.2.5 5.2.9 5.2.10 5.3 5.3.2 / 6 1 5.3.4 5.3.5 5.3.6 UPS / 5.3 5.3 5.3.7 , A A.3 n 5 4 <1/2TEa A.4 n 20 % <1/2TEa A.5 n 5 4 <1/3TEa 5.5 5.5.2 20 CLSI 1 2 3 4 cut-off / cut-point Heptimax®- Quest Diagnostics HCV HCV Oncotype DX®- PCR 21 - CYP2C9 P4502C9 VKORC1 K 1 95% 98 99% evaluation,to judge or calculate the quality, importance, amount or value of something )[ question word We shall need to evaluate how the new material stands up to wear and tear. ] validatio n, w he re the spe c ified re quire me nts are ade quate fo r an inte nde d use ve rific atio n pro vis io n o f obje c tive e vide nc e that a give n item fulfils spec ifie d require me nts 2 7 20.1 ( ) 20.6 4 16 1 1 1 2 3 5 “ ” 1 2 “ ” 2 ISO15189 4.4 : 4.4.1 B) • C) 5.5 ISO15189 4.6 4.6.2 5.5 5.5.1 / / 5.5.2 5.5.4 5.5.5 , CLIA’88 FDA CAP AMR CLIA 88 FDA FDA FDA CAP- ( Subpart K,CFR 493.1253) Cut-off Cut-off 6 Cut-off CLSI I/LA2-A2 Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2)Microtiter Enzyme Immunoassay Methods; Approved Guideline-Second Edition I/LA6-A Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Specimen Handling, and Use of Test Products in the Clinical Laboratory; Approved Guideline I/LA18-A2 Specifications for Immunological Testing for Infectious Diseases;Approved Guideline-Second Edition I/LA21-A Clinical Evaluation of Immunoassays; Approved Guideline I/LA23-A Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme,Fluorescence, and LuminescenceImmunoassays; Approved Guideline I/LA30-P Immunoassay Interference by Endogenous Antibodies Proposed Guideline FDA COMMISSION ON LABORATORY ACCREDITATION LABORATORY ACCREDITATION PROGRAM DIAGNOSTIC IMMUNOLOGY – SYPHILIS SEROLOGY CHECKLIST SUMMARY OF CHANGES 3 INSPECTION TECHNIQUES – KEY POINTS 5 LABORATORY SAFETY 7 PROFICIENCY TESTING 7 QUALITY MANAGEMENT AND QUALITY CONTROL 11 GENERAL ISSUES 11 PROCEDURE MANUAL 14 SPECIMEN COLLECTION AND HANDLING 17 RESULTS REPORTING 18 REAGENTS 19 CALIBRATION AND STANDARDS 22 CONTROLS 31 INSTRUMENTS AND EQUIPMENT 37 Analytic Balances 43 PROCEDURES AND TEST SYSTEMS 46 BLOOD TYPE, GROUP, AND/OR ANTIBODY SCREENS 46 SYPHILIS SEROLOGY 50 PERSONNEL 51 PHYSICAL FACILITIES 52 5.5 5.5.5 CUT OFF 1 120 3-5 3-5 X s CUT OFF X+3s 2 CUT OFF 20% 120 3-5 3-5 X s CUT OFF :X-3s EP12 C50 C50 C50 C5 C95 infection. for many microbiological qualitative tests is no recognized reference material. For many such antigen or antibody tests, Users must then rely on the labeling provided by the manufacturer for specific information on how the cutoff or limit of blank was established; or gain experience with the device in their patient population to correlate test results with clinical findings. CUT OFF 1 2 Leuey-Jennings CAP CUT OFF FDA ! 2- 8 -20 6 CUT OFF CUT OFF 2 CUT OFF 0.5 CUT OFF “HOOK ” CUT OFF -20 37 5 4-8 -20 10 10 4-8 - 20 1 ( ) 6 2 56 10 3 0.2 m 4 5 2 Cut Off 6 -20 7 CLIA’88 waived testing sites FDA CDC “CLIA’88 HIV <2007 > ” Levey-Jennings ELISA Levey-Jennings X Y 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 5.5 5.4 5.5 5.4 5.5 5.5 5.4 5.4 5.4 5.5 5.5 5.5 5.5 5.4 5.5 5.4 5.4 5.5 5.5 5.6 5.4 5.5 5.1 5.4 5.4 5.5 5.4 5.5 5.4 5.5 (1) 2 Westgard 3 cutoff cutoffcutoff1x ELISA cut off 0.105 0.067 0.215 0.215 [1+ 0.105-0.067 /0.105]=0.292 0.215 [1- 0.105-0.067 /0.105]=0.137 Y 0.292 0.215 0.137 0.058 cut off 36% Y 0.079 0.058 0.037