External quality assessment for measurement of serum cystatin C in China / 临床检验杂志

ABSTRACT

Objective To understand the current status of the measurement quality of serum Cystatin C (CysC) in China.Methods The external quality assessment (EQA) data in 2017 were collected from the network platform of National Center for Clinical Laboratories.The EQA data were classified into 8 groups according to different types of diagnostic reagents,each of which was employed by at least 18 users.The robust mean value and robust coefficients of variation (CV) were calculated according to ISO 13528 document in each group.The robust mean value was set as the target value.The total error derived from biological variation was used as the fine (3.8％),moderate (7.6％) and weak (11.4％) criteria in evaluating the pass rates,respectively.The reagents which were employed by more than 50 users were classified into subgroups named as " reagent-analyzer" group according to the used analyzer.The median values and differentials between maximum and minimum value were calculated for each reagent-analyzer subgroup.Results A total number of 710 laboratories submitted their results of CysC measurement during 2017.The fine,moderate and weak pass rates according to the setting criteria were 25.9％ (184/710),55.5 ％ (394/710) and 75.2％ (534/710),respectively.The variations of CysC measurement results of among different reagent-analyzer groups ranged from 1.62％ to 12.27％.Conclusion The quality of CysC measurement of should be improved with nationwide attention.