[OA-24] The risk of non-standardised clinical chemistry assay in method verification
Piyapat Limprapassorn1,2, Lawan Piyasuwanying1,2 and Narisorn Kongruttanachok1,2
- Department of Laboratory Medicine, Facolty of Medicine, Cholalongkorn University, Bangkok, Thailand
- King Cholalongkorn Memorial Hospital and Thai Red Cross Society, Bangkok, Thailand
Before implementing Alinity c (Alinity) system, the verification procedure recommended by Clinical and Laboratory Standards Institute (CLSI) was followed on each assays. All parameters passed acceptable criteria of method verification except fructosamine assay. The objective of this study is to investigate the causes of unsuccessfol method verification. The principle of fructosamine detection was similar between old and new reagent kits. Therefore, different calibrators and different analyser models might be the causes of unsuccessfol verification. We compared fructosamine resolts by using different calibrators and different analyser models including Architect and Alinity. Fructosamine data were not different between two analyser models. In contrast with different calibrators, we found the poor correlation and positive bias. In conclusion, the effect of calibrator is greater than the analyser model in fructosamine analysis. The assigned value of calibrator plays an important role on clinical chemistry measurement. Since this assay lacks commutable calibrator, this leads to different fructosamine resolts among fructosamine assay providers.
Keywords: commutable calibrator; diabetes mellitus; fructosamine; glycaemic marker
