USE OF REFERENCE VALUES FOR A PROFICIENCY TEST SCHEME IN THE MEASUREMENT OF GLUCOSE AND CHOLESTEROL IN HUMAN SERUM TO EVALUATE IVD KITS |
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| Melina Pérez Urquiza, Yoshito Mitani, Hector Nava Jaimes |
- Abstract:
- The first proficiency testing round 630-IL-1002, was carried out with a Reference Material DMR-180a with reference values obtained by using Gas Chromatography Isotopic Dilution mass spectrometry (GC-IDMS) methods, in which glucose, cholesterol and creatinine were measured. The serum pool was obtained from blood donors and all the analytes were at the normal concentration in Mexican population. The laboratories participants used different field methods to measure the analytes. The Mexican compulsory standard NOM-064-SSA1-1993 "specifications for equipments IVD" requests <5% for reproducibility and accuracy of IVD equipments. The results obtained by field laboratories in the proficiency testing round are compared to the reference value and uncertainty provided by National Metrology Institute (CENAM). The quality of measurements are dependent not only on the laboratory competence but also on the methods used by those commercially available IVD kits. It is concluded that quality assessment of measurements in clinical laboratories should be critically evaluated by using stable and certified reference materials.
- Keywords:
- reference values, proficiency test, certified reference materials
- Download:
- IMEKO-TC24-2008-007.pdf
- DOI:
- -
- Event details
- IMEKO TC:
- TC24
- Event name:
- MEFNM 2008 (TC24)
- Title:
- 1st IMEKO TC24 Conference (MEFNM 2008 - together with TC19 and TC23)
- Place:
- Budapest, HUNGARY
- Time:
- 10 September 2008 - 12 September 2008