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目的在cobas s201核酸检测系统投入使用前,验证其操作性能和检测性能是否可达到预期要求,确保检测系统性能与厂商声明的技术性能相匹配,可满足实验室的实际需求。方法通过通量测试、压力测试和试剂稳定性测试3个方面评估核酸检测系统的操作性能,通过设备间性能比对验证和分析灵敏度验证,评估检测系统的检测性能。设备间性能比对验证中分别在3台cobas s201核酸检测系统上使用6混样模式对比对血清盘进行检测,采用Kappa检验评估3套核酸检测设备检测结果的一致性;分析灵敏度验证使用cobas Taq Screen MPX 2.0检测试剂,采用WHO HIV-1、HCV和HBV标准株制备梯度浓度的分析灵敏度血清盘,对血清盘进行单人模式检测,采用Probit回归分析计算95%检出限(LOD),与试剂说明书的分析灵敏度进行比对。结果每套核酸检测系统24 h可完成1 440份标本的6混样模式检测,3套核酸检测系统在3 d压力测试运行期间均无故障发生。cobas Taq Screen MPX 2.0检测试剂室温放置24 h候仍可检测出弱阳性的HIV-1、HCV和HBV样本。在核酸检测系统间的性能比对验证中,3套核酸检测系统检测结果与血清盘一致。cobas Taq Screen MPX 2.0检测试剂HIV-1、HCV和HBV的95%检出限分别是34.58 IU/m L[(27.77-48.77)IU/m L]、16.38 IU/m L[(10.15-92.22)IU/m L]、1.32 IU/m L[(1.12-1.71)IU/m L]。结论 cobas s201核酸检测系统的通量、长时间运行下的设备状态和试剂稳定性都符合实验室需求,不同设备间不存在检测性能间的差异,检测系统的分析灵敏度与厂商声明无显著差别,可达到实际检测的需要。
Objective To verify whether the performance and detection performance of the cobas s201 nucleic acid detection system can meet the expected requirements before it is put into operation so as to ensure that the performance of the detection system matches the technical performance stated by the manufacturer and meet the actual needs of the laboratory. Methods The performance of the nucleic acid detection system was evaluated by three aspects of flux test, pressure test and reagent stability test. The performance of the detection system was evaluated through the verification of performance ratio between devices and the verification of analytical sensitivity. Equipment performance comparison verification of the three sets of cobas s201 nucleic acid detection system using the 6 mixed-mode comparison of the detection of the serum plate, using Kappa test to assess the consistency of the three sets of nucleic acid detection equipment test results; Analysis of sensitivity verification using cobas Taq Screen MPX 2.0 detection reagent was used to prepare gradient-sensitivity analytical serum disks using the WHO HIV-1, HCV, and HBV standard strains, single mode detection of the serum disks, 95% detection limit (LOD) using Probit regression analysis, and Reagents instructions for analysis of sensitivity comparison. RESULTS: A total of 1440 samples were tested for 6-fold pattern in each nucleic acid detection system within 24 hours. Three sets of nucleic acid detection systems showed no malfunction during the 3-day stress test. Cobas Taq Screen MPX 2.0 Detection Reagents Weak positive HIV-1, HCV and HBV samples were still detected at room temperature for 24 h. In the nucleic acid detection system performance verification between the comparison, the three sets of nucleic acid detection system test results consistent with the serum disk. The 95% detection limits for cobas Taq Screen MPX 2.0 detection reagent HIV-1, HCV and HBV were 34.58 IU / m L [(27.77-48.77) IU / m L], 16.38 IU / m L [(10.15-92.22) IU / m L], 1.32 IU / m L [(1.12-1.71) IU / m L]. Conclusion The flux of the cobas s201 nucleic acid detection system, the device status and reagent stability under long-term operation meet the needs of the laboratory. There is no difference between the detection performance of different devices. The analysis sensitivity of the detection system is not significantly different from that of the manufacturer. Can reach the actual test needs.