Abstract:

Objective To study the performance of 2 glycated hemoglobin A_1c （HbA_1c）point-of-care testing（POCT）analyzers in Shanghai. Methods External quality assessment samples were collected from remaining whole blood samples of Shanghai clinical laboratories. The mean values of 2 HbA_1c POCT analyzers （QUO-Test and NycoCard ReaderⅡglycated hemoglobin analyzers）（POCT group）were compared with the mean values of ionic exchange high pressure liquid phase method,ionic exchange low pressure liquid phase method and immuno-turbidimetry. The system bias between 2 HbA_1c POCT analyzers（±7%） was used as standard,and the bias of the mean values of the 2 HbA_1c POCT analyzers with the reference value assigned by the International Federation of Clinical Chemistry and Laboratory Medicine （IFCC）reference method was calculated. The allowable bias for trueness was ±6% as standard,and the intra-group coefficient of variation （CV）of the 2 HbA_1c POCT analyzers was calculated. Results For POCT group,the results of 2 HbA_1c POCT analyzers compared to the 3 conventional determination methods in 2015 were better than those in 2014. The bias of POCT group compared with high pressure liquid phase method was within allowable range. In 2014,the biases of QUO-Test with low pressure liquid phase method and immuno-turbidimetry were not good. The biases of NycoCard ReaderⅡ in 2014 were in good agreement with high pressure liquid phase method and immuno-turbidimetry,except low pressure liquid phase method. In 2004,for 5 quality control samples,the bias between POCT group and IFCC target value was positive bias. The bias between the mean value of QUO-Test and the target value was within the acceptable bias range except for a level of 7.7%. The bias between the mean value of NycoCard ReaderⅡ and the target value was within the acceptable bias range,which was less than that of QUO-Test. Conclusions NycoCard ReaderⅡ with conventional determination methods,especially high pressure liquid phase method has good comparability. The trueness is compliance with requirement,which can meet the needs of clinical determination.

Key words: Glycated hemoglobin A_1c, Point-of-care testing analyzer, Trueness