摘要
Abstract
Objective To verity the main analytic performance of AU2700 automatic biochemical analyzer for detecting potassium (K) , alanine aminotransferase (ALT) and creatinine (CREA) .Methods According to the requirements of the evaluation schemes (EP15-A2, EP6-A, EP7-A2) from the NCCLS and CLSI and health industry standards (WS/T 403-2012) , the precision, accuracy, linear range, interference phenomena and reference interval of K, ALT and CREA conducted the performance verification.Results The within-run precision (Sr) of K, ALT and CREA was both less than the within-run precision declared by the manufacturers, and the within-run coefficient of variation (CV) was less than 1/4 allowed total error (Tea) ;the within-Lab precision (Sl) was both less than the within-Lab precision declared by the manufacturers, and the within-Lab CV was less than 1/3 Tea;the accuracy of K, ALT, CREA was admirable, all laboratory average values fell within the confidence interval;the slopes of linear regression equation were 0.999-1.014, R2≥0.95;the clinical reportable ranges of K, ALT and CREA were 1-80 mmol/L, 1-6 000 U/L, 8.84-212 160μmol/L;the interferences (TBIL, TG, Hb) had no obvious interference on the detection of K, ALT and CREA, but the Hb concentration≥5 g/L had the interference on K.The 3-item reference interval verification results were in the reference interval quoted by this laboratory.Conclusion The performance of AU2700 biochemical analyzer for detecting K, ALT and CREA reaches the requirements of detection performance and can meet the clinical needs.关键词
性能验证/精密度/正确度/线性范围Key words
performance verification/precision/accuracy/linear range分类
医药卫生
