Use of Target Values in EQA
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1 Use of Target Values in EQA Dr. Anja Kessler Bonn, Germany 1
2 External Quality Assessment Example: Progesterone 580 participants Measurement principles: Luminescence detection Radioactivity detection Fluorescence detection Mass spectrometry... Which result is accurate? Are the results comparable within certain limits? 2
3 Traceability in Medicine SI-Unit (definition) Uncertainty µc(y) Primary reference Traceability Primary calibrator Secondary calibrator Mf. s working (master) calibrator Mf. s product calibrator Secondary reference Mf. s selected Mf. s standing End-user s routine BIPM: International Institute of Weights and Measures NMI: National Metrological Institute ACL: Accredited Calibration MCL: Manufacturer s Calibration ML: Manufacturer s Routine sample RESULT Mf: Manufacturer Adapted from ISO
4 Traceability for Measurands in EQA - present state- Alpha-fetoprotein Carbamazepine C-reactive protein Ferritin IgA, IgG,IgM pco2, po2 Valproic acid 4
5 Traceability in Medicine SI-Unit (definition) Uncertainty µc(y) Primary reference Traceability Primary calibrator Secondary calibrator Mf. s working (master) calibrator Mf. s product calibrator Secondary reference Mf. s selected Mf. s standing End-user s routine BIPM: International Institute of Weights and Measures NMI: National Metrological Institute ACL: Accredited Calibration MCL: Manufacturer s Calibration ML: Manufacturer s Routine sample RESULT Mf: Manufacturer Adapted from ISO
6 RiliBÄK Table B1a......
7 Kit Dependent Target Values 7
8 Traceability for Measurands in EQA - present state- Alpha-fetoprotein Carbamazepine C-reactive protein Ferritin IgA, IgG,IgM pco2, po2 Valproic acid ALT ALP AST CK GGT LDH HbA1c target value dependent on method/kit 8
9 Traceability in Medicine SI-Unit (definition) Uncertainty µc(y) Primary reference Traceability Primary calibrator Secondary calibrator Mf. s working (master) calibrator Mf. s product calibrator Secondary reference Mf. s selected Mf. s standing End-user s routine BIPM: International Institute of Weights and Measures NMI: National Metrological Institute ACL: Accredited Calibration MCL: Manufacturer s Calibration ML: Manufacturer s Routine sample RESULT Mf: Manufacturer Adapted from ISO
10 Traceability in Medicine SI-Unit (definition) Uncertainty µc(y) Primary reference Traceability Primary calibrator Secondary calibrator Mf. s working (master) calibrator Mf. s product calibrator Secondary reference Mf. s selected Mf. s standing End-user s routine BIPM: International Institute of Weights and Measures NMI: National Metrological Institute ACL: Accredited Calibration MCL: Manufacturer s Calibration ML: Manufacturer s Routine sample RESULT Mf: Manufacturer Adapted from ISO
11 RiliBÄK Table B1a......
12 Enzymes Situation before Standardization 12
13 Enzymes Situation after Standardization 13
14 Traceability for Measurands in EQA - present state- Alpha-fetoprotein Carbamazepine C-reactive protein Ferritin IgA, IgG,IgM pco2, po2 Valproic acid target value dependent on method/kit ALT ALP AST CK GGT LDH HbA1c Creatinine Glucose Total cholesterol Cortisol 17ß-estradiol Progesterone Testosterone reference target value independent on method/kit 14
15 Traceability in Medicine SI-Unit (definition) Uncertainty µc(y) Primary reference Traceability Primary calibrator Secondary calibrator Mf. s working (master) calibrator Mf. s product calibrator Secondary reference Mf. s selected Mf. s standing End-user s routine BIPM: International Institute of Weights and Measures NMI: National Metrological Institute ACL: Accredited Calibration MCL: Manufacturer s Calibration ML: Manufacturer s Routine sample RESULT Mf: Manufacturer Adapted from ISO
16 RiliBÄK Table B1a......
17 Survey Hormones 17
18 Joint Committee for Traceability in Medicine : JCTLM database REFERENCE MEASUREMENT SYSTEMS Reference materials Reference s Services of reference laboratories 18
19 Reference Measurement Systems The laboratory has to make use of a reference approved according to ISO and reference materials approved according to ISO The laboratory has to be accreditated according to ISO/IEC and ISO The laboratory has to participate regularly in collaborative surveys for calibration laboratories. 19
20 EQA for Calibration Laboratories 20
21 EQA for Calibration Laboratories 21
22 EQA for Calibration Laboratories 22
23 Linking Routine and Calibration Laboratories Testosterone HM 1/16 vs. RELA routine labs 3 calibration labs Limits of Acceptance: 35% 23
24 Implementation of Traceability The implementation of quality assurance for clinical measurands requires the support of National Metrology Institutes Scientific Societies of Clinical Chemistry and Medicine Accreditation Bodies Suppliers of Certified Reference Materials Calibration Laboratories (also known as: Reference Measurement Laboratories) IVD Industry External Quality Assessment Organizers Legal Authorities Medical Laboratories themselves 24
25 Summary and Outlook About 40 reference systems are available to assign independent target values for interlaboratory comparisons. (most frequently analysed measurands) However, many measurands still have to be evaluated by method/kit dependent target values. Scientific work is necessary to develop reference systems for further measurands in laboratory medicine. The implementation of traceability in laboratory medicine and the improvement of comparability of EQA results depend on the contribution of many parties. 25
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