NDLI: Proficiency tests to evaluate commercially available IVD kits for glucose and cholesterol measurements

Content Provider	Springer Nature Link
Author	Urquiza, Melina Pérez Mitani, Yoshito Jaimes, Hector O. Nava
Copyright Year	2009
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 isotope dilution mass spectrometry 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 in vitro diagnostic (IVD)” requests 5% precision and 5% maximum bias of the IVD equipments in the measurements of analytes like glucose and cholesterol. The results obtained by field laboratories in the proficiency testing round are compared to the reference value and uncertainty provided by the National Metrology Institute (CENAM). The quality of measurements is 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.
Starting Page	269
Ending Page	271
Page Count	3
File Format	PDF
ISSN	09491775
Journal	Accreditation and Quality Assurance
Volume Number	14
Issue Number	5
e-ISSN	14320517
Language	English
Publisher	Springer-Verlag
Publisher Date	2009-02-21
Publisher Place	Berlin, Heidelberg
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Glucose Cholesterol Serum Proficiency test Certified reference materials Marketing Ecotoxicology Biochemistry Analytical Chemistry Commercial Law Food Science
Content Type	Text
Resource Type	Article
Subject	Chemistry Instrumentation Chemical Engineering Safety, Risk, Reliability and Quality

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