论文部分内容阅读
目的:确认血液病毒核酸检测(NAT)仪器在使用前,其性能可以满足实际检测工作要求。方法:为确认设备的检测灵敏度、特异性、重复性、可靠性和防止污染等性能,设计4个试验组:联检试验组和鉴别试验组,将生理盐水标本和NAT质控品(HBV DNA、HIV-1RNA、HCV RNA)交叉放置于标本架上,进行NAT联检和鉴别检测;仪器比对组用同一批献血者标本在同类型的2台仪器上进行检测;污染评估试验组用生理盐水作为阴性标本进行NAT联检。结果:所有NAT检测结果均与预期一致。结论:血液病毒核酸检测设的各项性能满足实际检测工作要求。
Objective: To confirm the performance of the blood virus nucleic acid detection (NAT) instrument before use, to meet the actual testing requirements. Methods: In order to confirm the sensitivity, specificity, repeatability, reliability and pollution prevention of the equipment, four test groups were designed: joint test group and identification test group. Normal saline samples and NAT control samples (HBV DNA, HIV-1 RNA, HCV RNA) were cross-placed on the specimen rack for NAT detection and differential detection. The instrument control group was tested on two instruments of the same type using the same blood donor samples. The contamination evaluation test group was treated with saline Negative specimens for NAT joint inspection. Results: All NAT test results were as expected. Conclusion: The performance of blood virus nucleic acid test set to meet the actual testing requirements.