7种微小RNA检测试剂的多中心评估

Multicenter performance evaluation of a 7-microRNA test kit

目的评估某品牌7种微小RNA(miRNA)检测试剂盒的检测性能。方法采用多中心横向联合评价方法,在全国范围内选择10家检测中心在同一时间使用同一批样本,对同一批号试剂进行性能评估。检测项目为miR-21、miR-26a、miR-27a、miR-122、miR-192、miR-223和miR-801,以miR-1228为内参。评估参数包括精密度、符合率、检出限和抗干扰能力。结果10家检测中心检测8种miRNA的循环阀值(Ct)的批内变异系数(CV)均<5.00%,批间CV均<6.50%。10家检测中心检测20例临床血浆样本的总符合率均为100.00%(20/20),对50拷贝/μL标准参考品的检出率均为100.00%(20/20)。血红蛋白200 g/L、胆红素1000μmol/L和三酰甘油100 mmol/L对检测结果无明显干扰。结论该试剂盒检测7种miRNA的精密度、符合率、检出限和抗干扰能力表现良好,可满足不同地区、不同实验室和不同检测系统的使用需求和预期用途,具有一定的临床应用价值。

Objective To evaluate the determination performance of a 7-microRNA(miRNA)test kit.Methods A total of 10 laboratory centers used the same samples to evaluate the performance of the same batch of reagents during the same period through multicenter evaluation.The determination objects were miR-21,miR-26a,miR-27a,miR-122,miR-192,miR-223 and miR-801,with miR-1228 as the internal reference.The evaluation parameters included precision,consistency,determination limit and anti-interference capability.Results The intra-batch coefficient of variation(CV)and inter-batch CV of cycle threshold(Ct)values of the 10 laboratory centers for 8 miRNA were all<5.00%and<6.50%,respectively.The total consistency of 20 clinical plasma samples determined by the 10 laboratory centers was 100.00%(20/20).The determination rate of 50 copies/μL standard reference materials determined by the 10 laboratory centers was 100.00%(20/20).The interfering substances with the final concentration of 200 g/L hemoglobin,1000μmol/L bilirubin and 100 mmol/L triglyceride had no interference on the determination results.Conclusions The precision,consistency,determination limit and anti-interference capability of this kit are good,which can meet the different needs of regions,laboratories and determination systems.It has certain clinical application value.