Performance verification of three ischemia-modified albumin reagents / 国际检验医学杂志

ABSTRACT

Objective To verify the performance of three kinds of ischemia‐modified albumin(IMA) reagents .Methods The performance of three IMA reagents(labeled as reagent A ,B ,C) using colorimetric method from Shanghai Aikang Biotechnology Co .,Ltd .,Zhejiang Kuake Bioscience Technology Co .ltd .and Beijing Jiuqiang Biotechnology Co .,Ltd .were assessed by using O‐lympus AU5800 automatic biochemistry analyzer .According to the National Committee for Clinical Laboratory(NCCLS) EP6‐A , EP15‐A and EP7‐A documents and WS/T 420‐2013 verificationof analytical performance of quantitative kits by clinical labo‐ratory ,the precision ,linearity range ,accuracy and anti‐interference capability were assessed .Results The within‐run coefficient of variations(CVs) of reagent A ,B and C were 0 .59% -0 .82% ,0 .27% -0 .54% and 0 .62% -0 .69% respectively .The between‐run CVs of reagent A ,B and C were 0 .98% -1 .74% ,0 .99% -1 .01% and 0 .71% -0 .78% ,respectively ,which were lower than decla‐rations of these reagent kits .The linearity range of reagent A ,B and C were 11 -142 U/mL(r2 = 0 .993) ,10 -120 U/mL(r2 =0 .996) ,14-123 U/mL(r2 =0 .992) respectively ,which showed good linearities .About interference tests ,no remarkable interfer‐ences(all Bias were less than ± 10% ) of reagent A ,B and C were detected when Vitamin C≤10 mg/dL ,hemoglobin≤200 mg/dL , bilirubin≤40 mg/dL and triglyceride≤500 mg/dL .Conclusion The three IMA reagents show high precision ,which could meet clinical requirements ,nevertheless ,differences of anti‐interference capabilities are observed in these three reagents .