摘要
目的探讨中小血站核酸检测系统的性能验证方法,验证其检测和操作性能能否满足日常检测要求。方法通过通量测试、压力测试、分析灵敏度验证、不同系统间平行试验、抗交叉污染试验、室间质量评价正确率等方面评估检测系统的性能。结果浩源核酸检测系统6 h完成一批满负荷384份标本的8混样检测,压力测试试验过程设备软硬件均未发生故障。分析灵敏度验证中0.5检出限(LOD)的质控品标本HBV DNA、HCV RNA、HIV1 RNA阳性检出率分别为100%、75%、60%,1.0 LOD和2.0 LOD的质控品标本HBV DNA、HCV RNA、HIV1 RNA检出率均为100%,反应性标本的Ct值变异系数均小于5%。平行试验、抗交叉污染试验结果均与预期结果一致。EQA正确率为100%。结论浩源核酸检测系统的操作性能、分析灵敏度、抗交叉污染能力、检测能力均能满足预期要求,该确认方法可作为中小血站核酸检测系统性能验证的参考。
Objective To explore the performance confirmation method of in-use nucleic acid test system in small and medium-sized blood stations,and verify its performance and operability.Methods The performance of the system was evaluated by throughput test,stress test,sensitivity verification,parallel test,anti-cross-contamination test and accuracy of external quality assessment.Results Haoyuan nucleic acid test system completed a batch of full load of 384 samples of 8 mixed sample detection,stress test equipment software and hardware testing process without failure.The positive rates of HBV DNA,HCV RNA and HIV1 RNA in the 0.5LOD range were 100%,75%and 60%,respectively,1.0 LOD and 2.0 LOD HBV DNA,HCV RNA,HIV1 RNA detection rates were 100%,and the statistical coefficient of variation of CT value of positive samples was less than 5%.The results of parallel test and anti-cross-contamination test were consistent with the expected results.The accuracy rate of EQA was 100%.Conclusion The operation performance,analysis sensitivity,anti-cross-contamination ability and detection ability of Haoyuan nucleic acid test system could meet the expected requirements.
作者
陈凯
王英辉
袁志凤
CHEN Kai;WANG Yinghui;YUAN Zhifeng(Rizhao Blood Station,Rizhao,276800,China;Rizhao Mental Health Center)
出处
《临床血液学杂志》
CAS
2022年第8期584-586,591,共4页
Journal of Clinical Hematology
关键词
性能验证
分析灵敏度
定值质控品
核酸检测系统
performance validation
analysis sensitivity
quality control
nucleic acid test system
