全自动核酸血液筛查系统COBAS S201标本离心时限和检测时限的性能验证

Performance Verification of Automatic Nucleic Acid Screening System COBAS S201 on Sample Centrifugation Time Limit and Detection Time Limit

目的验证全自动核酸血液筛查系统COBAS S201标本离心时限和检测时限的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,并满足实验室的性能要求。方法将已知浓度的乙型肝炎病毒(HBV)DNA、丙型肝炎病毒(HCV)RNA、人类免疫缺陷病毒(HIV)RNA标准物质与阴性献血者未离心的新鲜全血混合后分别稀释至1~3倍检测限,在不同时间段离心、不同时间段检测病毒核酸物质。结果样本在4 h、24 h、3 d内的离心检测结果均呈反应性,样本在24 h、3 d、5 d及7 d(除1倍检测限HBV外)内的检测结果均呈反应性;不同离心时限和不同检测时限的标本循环阈值(CT值)比较,差异均无统计学意义(P>0.05),检测结果显示离心时限和检测时限设置基本符合预期结果。结论全自动核酸血液筛查系统COBAS S201标本离心时限和检测时限基本满足血站对核酸检测的相关要求。

Objective Whether the sample centrifugation time limit and detection time limit of automatic nucleic acid screening system COBAS S201 could meet the expected requirements were confirmed to ensure that the performance of the detection system could match the technical performances stated by the manufacturer and meet the performance requirements of the laboratory.Methods The standard substance(concentration was known)of hepatitis B virus(HBV)DNA,hepatitis C virus(HCV)RNA,human immunodeficiency virus(HIV)RNA were diluted to 3 different concentrations which equal to 1~3 times of the detection limit with the fresh whole blood from negative blood donors(without centrifugation)respectively,and then the the diluted samples were detected for virus nucleic acid at different centrifugation times and different detection times.Results The detection results of the samples centrifuged at 4 h,24 h and 3 d after collected were all reactivity.The detection results of the samples detected at 24 h、3 d、5 d and 7 d(except for HBV DNA of 1 times detection limit)after collected were all reactivity.There were no statistically significant differences in CT values of samples with different centrifugation time limit and different detection time limit(P>0.05),indicating that manufactures'stated parameters about centrifugation time limit and detection time limit could basically meet the expected results.Conclusion The automatic nucleic acid screening system COBAS S201 could basically meet the related requirements of nucleic acid detection in the aspects of centrifugation time limit and detection time limit.