一种人乳头瘤病毒核酸23个分型检测试剂盒的性能验证及评价

Performance Verification and Evaluation of A Human Papillomavirus Nucleic Acid Detection Kit with 23 subtypes

目的对某人乳头瘤病毒(23个分型)核酸分型检测试剂盒(荧光PCR法)进行性能验证。方法依据试剂盒说明书及CNAS-GL039依次对试剂盒的交叉反应、符合率、检测限、抗干扰能力进行验证与评价。结果人乳头瘤病毒(23个分型)核酸分型检测试剂盒与淋球菌、沙眼衣原体及解脲支原体不存在交叉反应;阴、阳性符合率为100%;该检测试剂盒检测限为104copy/mL,检出率100%;5%的血红蛋白和5%的咪康唑不会对人乳头瘤病毒分型检测造成干扰。结论该试剂盒交叉反应、符合率、检测限、抗干扰能力均符合要求,可满足本实验室的检测需求。

Objective To verify performance of a human papillomavirus(with 23 subtypes)nucleic acid detection kit(with fluorescence PCR method).Methods The paper verified and evaluated cross reaction,coincidence rate,detection limit and anti-interference ability of the kit in sequence based on kit manual and CNAS-GL039.Results There was no cross reaction between the kit and neisseria gonorrhoeae,chlamydia trachomatis and ureaplasma urealyticum;coincidence rate of negative and positive was 100%;detection limit of the test kit was 104 copy/ml,and detection rate was 100%;5%hemoglobin and 5%miconazole did not interfere with HPV typing.Conclusion Cross reaction,compliance rate,detection limit and anti-interference ability meets requirements,which can meet testing requirements of our laboratory.