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目的探讨Roche E601全自动电化学发光免疫分析仪丙型肝炎病毒(HCV)剩余试剂合并再利用的可行性。方法采用合并剩余试剂分别检测特定血清中HCV的含量,并进行精密度、准确性、回收率和灵敏度比对分析;与新试剂一起分别检测同一组标本中有反应性和无反应性HCV的含量,并做均值比较及相关性分析。结果合并剩余试剂检测HCV低、中、高浓度血清(或质控)批内、批间变异系数(CV)均符合厂商提供的CV值。质控品准确性在允许范围内,回收率均值在80%~120%之间。用合并剩余试剂与新试剂分别检测有反应性和无反应性标本,各组均值比较,差异无统计学意义(P>0.05)。结论 Roche E601免疫分析仪可以对剩余试剂合并再利用,能够保证检测质量,降低检测成本。
Objective To investigate the feasibility of combining and reusing the remaining reagents of Hepatitis C virus (Roche E601) automated electrogenerated chemiluminescence immunoassay. Methods The combined reagents were used to detect the content of HCV in specific serum respectively, and the accuracy, accuracy, recovery and sensitivity were analyzed. The content of reactive and non-responsive HCV in the same sample , And mean comparison and correlation analysis. Results The results showed that the coefficient of variation (CV) between the two groups was within the CV value provided by the manufacturer. Quality control accuracy within the allowable range, the average recovery rate of 80% to 120%. Reactive and non-responsive specimens were detected with the remaining reagent and the new reagent, respectively. There was no significant difference between the mean values in each group (P> 0.05). Conclusion The Roche E601 immunoassay analyzer can recycle the remaining reagents to ensure the quality of detection and reduce the cost of detection.