高海拔地区血液筛查核酸检测系统性能验证结果评价

Performance evaluation of nucleic acid testing system for blood screening in high-altitude areas

目的 对西藏那曲地区(高海拔)的血液筛查核酸检测系统进行性能验证,以评估高海拔地区核酸检测的能力,进一步提升血液安全水平。方法 采用多种方法对核酸检测系统的分析灵敏度、重复性、防交叉污染能力以及不同系统间的比对等进行评估。结果 西藏那曲地区核酸检测系统对高浓度的HBV DNA和HIV-1 RNA标本的检出率均达到100%,中浓度标本的检出率超过90%;PROBIT分析结果显示,在HBV DNA和HIV-1 RNA的最低检出限(LOD)分别为8.29 IU/mL(95%CI, 5.88~20.55 IU/mL)和40.52 IU/mL (95%CI, 30.26~85.92 IU/mL),HCV RNA 2a型97.14 IU/mL (95%CI, 71.00~182.67 IU/mL),均低于说明书声明的最低检出浓度。在重复性分析中,系统的重复性达到100%。交叉污染性能验证结果显示,系统具有良好的抗交叉污染能力。通过对HBV DNA低浓度标本的重复检测和低海拔地区的多系统检测结果比对,检测结果的一致性分别为77.78%(14/18)和77.27%(17/22),结果显示那曲地区核酸检测系统与其他系统存在一定的差异。结论 该核酸检测系统在高海拔地区的血液筛查中表现出良好的性能。高海拔地区血液筛查核酸检测系统性能验证方面的研究结果与低海拔地区基本一致,为提升高海拔地区血液安全提供了可靠依据。

Objective To validate the performance of a nucleic acid testing(NAT)system for blood screening in the high-altitude Nagqu region of Tibet,in order to assess the capability of NAT in high-altitude areas and further enhance blood safety.Methods Various methods were employed to evaluate the analytical sensitivity,reproducibility,ability to prevent cross-contamination,and comparison between different NAT systems.Results The NAT system in the Nagqu region of Tibet achieved a 100%detection rate for high-concentration HBV DNA and HIV-1 RNA samples,and over 90%for medium-concentration samples.PROBIT analysis revealed the lower limits of detection(LOD)for HBV DNA and HIV-1 RNA to be 8.29 IU/mL(95%CI,5.88~20.55 IU/mL)and 40.52 IU/mL(95%CI,30.26~85.92 IU/mL),respectively.For HCV RNA genotype 2a,the LOD was 97.14 IU/mL(95%CI,71.00~182.67 IU/mL),all of which were lower than the declared minimum detectable concentrations in the instructions.Reproducibility analysis demonstrated a 100%level of consistency within the system.Cross-contamination performance verification showed a strong ability to resist cross-contamination.Comparative analysis of repeated testing of low-concentration HBV DNA samples and multi-system testing in plain areas revealed consistency rates of 77.78%(14/18)and 77.27%(17/22),respectively,indicating certain differences between the NAT system in Nagqu region and other systems.Conclusion The NAT system exhibited excellent performance in blood screening at high altitudes.The results of performance validation in high-altitude blood screening NAT systems were largely consistent with those in plain areas,providing a reliable basis for enhancing blood safety in high-altitude regions.