国产核酸检测试剂盒在献血者血液筛查中的应用性能评估

Performance evaluation of the domestic nucleic acid detection kit in blood donation screening

目的:了解国产核酸检测试剂在血液筛查中应用的稳定性及准确性,为NAT技术用于常规血液筛查提供理论基础和实验依据。方法:通过将WHO-HBV/WHO-HCV/WHO-HIV国际标准品稀释至不同浓度,应用国产核酸检测试剂盒进行核酸检测并对每个稀释度重复检测6次;对卫生部临检中心提供室内质控品B01/C01/HO4-a连续开展60次核酸检测。结果:(1)WHO-HBV每个稀释后标准液检出率均为100%;WHO-HCV稀释后标准液(20 IU/ml)检出率为66.7%,标准液(10 IU/ml)检出率为33.3%,其余检出率都为100%;WHO-HIV稀释后标准液(50 IU/ml)检出率为83.3%,标准液(10 IU/ml)检出率为83.3%,其余检出率都为100%;(2)精密性测试中B01检测结果 39.02,s=0.81,cv=2.07%;C01检测结果36.6,s=0.92,cv=2.52%;H04-a检测结果 32.4,s=0.57,cv=1.75%。结论:国产核酸检测试剂在献血者血液筛查中的稳定性和准确性能够有效的保障临床用血安全。

Objective To evaluate the stability and accuracy of the domestic nucleic acid detection kit in blood donation screening, providing the theoretical basis and experimental evidence for the NAT assay in regular blood screening. Methods： The WHO international standard substance for HBV DNA , HCV RNA and HIV RNA diluted to various concentrations were tested by the domestic nucleic acid detection kit, and each dilution was detected 6 times. The Internal Quality Control product from NCCL （ B01/C01/H04 - a） was detected for continuous 60 times. Results： 1. Among the standard samples from diluted WHO - HBV, the positive rate was 100% ; Among the standard samples from diluted WHO - HCV, the positive rates of samples which had a concentration of 20 IU/ml and 10 IU/ml were 66.7% and 33.3% respectively, while others were all 100% ; Among the standard samples from diluted WHO - HIV, the positive rates of samples which had a concentration of 50 IU/ml and 10 IU/ml were both 83. 3 %, while others were all 100%. 2. In the precision test, it can be known 39.02, s = 0.81, cv =2.07% from the examination result of B01, 36.6, s = 0.92, cv = 2.52% from the examination result of C01, 32.4, s = 0.57, cv = 1. 75% from the examination result of H04 - a. Conclusion： The stability and accuracy of domestic nucleic testing kit can be effective protection to blood safety in screening blood donors.