ARCHITECT C16000全自动生化分析仪检测谷胱甘肽还原酶的性能评价

Evaluation of performance of ARCHITECT C16000 automatic biochemical analyzer in detecting serum glutathione reductase

目的 使用ARCHITECT C16000全自动生化分析仪对谷胱甘肽还原酶(glutathione reductase, GR)试剂盒进行性能评价。方法 使用120例健康人血清作为GR低值和正常值标本、10例肝病患者血清作为GR高值标本,具有溯源的校准品作为参考物,商品化的干扰物质等加入正常血清模拟常见的异常标本,参考美国临床和实验室标准化协会(CLSI)和中国合格评定国家认可委员会(CNAS)相关系列文件,对ARCHITECT C16000系列全自动生化分析仪上所使用的GR测定试剂盒进行精密度、正确度、线性范围、最大可稀释度、临床可报告范围、抗干扰能力及生物参考区间等参数进行验证。结果 健康人群低浓度血清、肝病患者高浓度GR血清样本验证的批内变异系数(CV)分别为0.59%和0.46%,批间CV分别为1.32%和1.22%,相对偏差为-1.81%;使用患者高值血清和健康人低值血清验证的GR浓度在10~340 U/L范围内为可接受的线性检测范围;使用检测上限附近的患者血清进行稀释的回收试验,验证的最大可稀释倍数为4倍,验证的临床可报告范围为10~1 360 U/L。使用干扰物质验证:当血清中游离胆红素≤20 mg/dL、结合胆红素≤20 mg/dL、甘油三酯≤20 mg/dL、血红蛋白≤50 mg/dL时,对GR检测结果无明显干扰。在120例体检健康人群中有95%个体测定值在厂家提供的参考范围内,33~73 U/L生物参考区间符合95%的健康人群。结论 经使用健康人、GR升高的肝病患者、校准品、干扰物质验证、GR试剂盒与ARCHITECT C16000全自动生化分析仪组成的GR检测系统的性能符合行业要求,可应用于临床分析。

Objective to evaluate the performance of Glutathione Reductase(GR) kit by using ARCHITECT C16000 automatic biochemical analyzer.Methods Using serum samples from 120 healthy individuals as low and normal GR value specimens, and serum samples from 10 liver disease patients as high GR value specimens. Traceable calibrators were used as reference materials, and commercial interference substances were added to normal serum to simulate common abnormal specimens. With reference to the American Clinical and Laboratory Standardization Association(CLSI) and the China National Accreditation Service for Conformity Assessment(CNAS), Precision, accuracy, linear range, maximum dilution ratio, clinical reportable range, anti-interference ability and biological reference interval of GR assay kit used in ARCHITECT C16000 series automatic biochemical analyzer were verified.Results The intra-batch coefficient of variation(CV) for low concentration serum from healthy individuals and high concentration GR serum from liver disease patients was 0.59% and 0.46%, respectively, with inter-batch CVs of 1.32% and 1.22%, the measured relative deviation was-1.81%. The acceptable linear detection range for GR concentrations, verified using high-value patient serum and low-value healthy serum, was 10-340 U/L. The maximum validated dilution ratio, verified through recovery tests using patient serum near the upper detection limit, was 4 times, with a clinically reportable range of 10-1360 U/L. Interference substance verification showed there was no significantly effect on the GR detection when free bilirubin ≤20 mg/dL, conjugated bilirubin ≤20 mg/dL, triglyceride ≤20 mg/dL or hemoglobin ≤50 mg/dL. In a group of 120 healthy individuals, 95% of measured values were within the reference range provided by the manufacturer, with a biological reference interval of 33-73 U/L matching 95% of the healthy population.Conclusion The performance of GR testing system which was grouped GR Kit and the Architect C16000 automatic biochemical analyzer satisfy the industry criterion and is suitable for clinical application.