Performance verification of six enzymatic glycated albumin reagents

Objective To validate the performance of six enzymatic glycated albumin reagents and evaluate their clinical application. Methods The performance of six enzymatic glycated albumin reagents(labled as A, B, C, D, E, F) from Beijing Jiuqiang Co, Beijing Lideman Co, Ningbomeikang Co, Beijing Haomai Co, Sichuan Maike Co and Asahi Kasei Co were assessed on Olympus AU5800 automatic biochemistry analyzer. According to the standard of CLSI, the precision, interference and linear correlation of these reagents were assessed.To assess the accuracy of GA% , we used GA standard material whose value had been assigned using ID-LC/MS method provided by ReCCS.To do the method comparison and determine the consistency of assay, 50 fresh serum samples of T2DM outpatient and 80 fresh serum samples of apparently healthy people in Jan 2016 were tested using six kits.According to the EP28-A3C protocol, the reference range for GA%was validated in 122 apparently healthy individuals undertaking medical examination from January to February 2016 in PUMC. Results The precision, and the ability of anti-interference of the six reagents were good.The accuracy percentage deviation of six reagents was -19.3%-9.2%.The correlation coefficient of domestic reagents A to E and imported reagents F in the determination of GA% was 0.966-0.999, the average absolute bias was 7.0%-10.4%.The coincidence rate of A-E and F in determining abnormal GA% was between 88.5% and 96.9%.The coincidence rate was increased after switching to the reference range for preliminary clinical evaluation. Conclusion Six GA enzymatic kits used in automatic biochemical analyzer have high precision and strong anti-interference ability.Accuracy still needs to be improved.((Chin J Lab Med, 2017, 40: 346-442) Key words: Serum albumin; Enzymic assays; Reference value