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目的评估、验证某国产血液NAT试剂盒用于血液筛查的技术性能指标。方法对某国产血液NAT试剂盒进行了灵敏度、特异性、重复性、抗干扰能力和抗污染能力测试,并将其初步用于血液筛查。结果乙型肝炎病毒(hepatitis B virus,HBV)DNA、丙型肝炎病毒(hepatitis C virus,HCV)RNA、人类免疫缺陷病毒(human immunodeficiency virus,HIV)RNA三者检测灵敏度分别为不高于50 IU/m L、50 IU/m L与100 IU/m L;特异性、重复性、抗污染能力能满足血站血液核酸检测需求;混检模式下,HBV DNA、HCV RNA、HIV RNA三者的检出基本不受脂肪血颗粒的影响,但在单检模式下会导致HIV RNA的漏检,溶血对HBV DNA HCV RNA、HIV RNA的检出均有明显干扰。结论某国产NAT检测分析系统的灵敏度、特异性、重复性、抗污染能力等指标均达《血站核酸检测质量控制指南》要求,脂肪血、溶血样本能明显干扰HBV DNA、HCV RNA、HIV RNA的检出能力。
Objective To evaluate and validate the technical performance index of a domestic blood NAT kit for blood screening. Methods To test the sensitivity, specificity, repeatability, anti-interference ability and anti-contamination ability of a domestic blood NAT kit and to use it initially in blood screening. Results The detection sensitivity of hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) RNA and human immunodeficiency virus (HIV) RNA was no more than 50 IU / m L, 50 IU / m L and 100 IU / m L; specificity, repeatability, anti-pollution ability to meet blood testing needs of blood cells; mixed mode, HBV DNA, HCV RNA, HIV RNA three Detection of the basic not affected by the role of fat blood particles, but in a single-seizure mode will lead to undetectable HIV RNA, hemolysis of HBV DNA HCV RNA, HIV RNA were detected significant interference. Conclusion The indicators of sensitivity, specificity, repeatability and anti-contamination of a domestic NAT detection and analysis system reach the requirements of the Guidelines for Quality Control of Blood Nucleic Acid Detection. Fatty blood and hemolysis samples can significantly interfere with HBV DNA, HCV RNA and HIV RNA The detection ability.