摘要
目的对一种国产血液核酸检测系统用于血源筛查的主要性能指标及其应用价值进行评价。方法参考WS/T 492-2016文件要求对检测系统的精密度、抗交叉污染能力、灵敏度、抗干扰能力、样本保存稳定性及准确性进行验证分析。结果HBV-DNA、HCV-RNA、HIV-RNA重复检测的变异系数(CV)分别为1.88%、1.06%、1.58%;7例阴性和7例阳性样本一阴一阳交叉排列单检未见交叉污染;单检灵敏度为HBV-DNA 2.5 IU/mL、HCV-RNA 12.5 IU/mL、HIV-RNA 12.5 IU/mL,混检灵敏度浓度为HBV-DNA20 IU/mL、HCV-RNA 100 IU/mL、HIV-RNA 250 IU/mL;溶血标本对于阳性标本的检出影响不大,严重脂血标本(如指数6时)会导致HIV的CT值延后;样本在2~8℃条件保存72 h内对检出影响不明显,超过72 h后HBV-DNA与HIV-RNA的CT值会有轻微延后。30例室间质评样本混检和拆分检验阳性样本、阴性样本符合率均为100%;与全国该试剂均值比较,HBV-DNA(混样t=0.060,P=0.953;拆分t=-0.619,P=0.543)、HCV-RNA(混样Z=-0.378,P=0.705;拆分Z=-1.592,P=0.111)、HIV-RNA(混样t=1.901,P=0.082;拆分t=-0.899,P=0.386)阳性样本CT值差异无统计学意义(P均>0.05)。阴性样本CT值均为45。该系统与罗氏系统混样和拆分检测30例室间质量评价样本的结果均完全一致。结论该国产血液核酸检测系统各项指标在本实验室条件下均可达到或优于厂家声明的性能,能满足本站血液核酸检测需求。
Objective To evaluate the main performance index and the application value of a domestic blood nucleic acid detection system in blood screening.Methods The precision,anti⁃cross⁃contamination,detection limits,anti⁃interference,sample storage stability and accuracy of the DaAn blood nucleic acid detection system were verified with reference to the requirements of the relevant documents of WS/T 492⁃2016.Results The coefficient of variation for repeated detection of HBV⁃DNA、HCV⁃RNA and HIV⁃RNA were 1.88%、1.06%and 1.58%,respectively.There were no cross contamination between 7 negative samples and 7 positive samples arranged in a cross way.The detection limits of HBV⁃DNA,HCV⁃RNA and HIV⁃RNA were 2.5 IU/mL,12.5 IU/mL and 12.5 IU/mL,while those were 20 IU/mL,100 IU/mL and 250 IU/mL in 8⁃in⁃1 mixed mode.Hemolysis had no significant impact to the detection of positive samples,while severe hyperlipidemia specimens(when index of chyle were 6)influenced the CT value of HIV⁃RNA and made it delay.Samples preserved in 2~8℃conditions within 72 hours had no significant impact to check out,and more than 72 hours HBV⁃DNA and HIV⁃RNA CT value will be a slight delay.The detection coincidence rate of 30 external quality assessment samples(include negative samples and positive samples)was 100%.Compared with the national average,there were no significant difference in CT value of positive samples of HBV⁃DNA(mixed test:t=0.060,P=0.953;split test:t=-0.619,P=0.543),HCV⁃RNA(mixed test:Z=-0.378,P=0.705;split test:Z=-1.592,P=0.111)and HIV⁃RNA(mixed test:t=1.901,P=0.082;split test:t=-0.899,P=0.386)(P>0.05).The CT value of negative samples was 45.Compared with roche system,the domestic blood nucleic acid detection system had the same result in testing 30 external quality assessment samples.Conlusion The main performance index of the domestic blood nucleic acid detection system can reach or exceed the performance declared by the manufacturer under the conditions of detection.The domestic blood nucleic aci
作者
詹莉
杨文杰
陈志强
范章平
ZHAN Li;YANG Wenjie;CHEN Zhiqiang;FAN Zhangping(Department Clinical Laboratory,Maoming Center Blood Station,Maoming,Guangdong,China,525000)
出处
《分子诊断与治疗杂志》
2023年第3期442-445,449,共5页
Journal of Molecular Diagnostics and Therapy
基金
茂名市科技计划项目(210406194552019)。
关键词
核酸检测
血源筛查
性能验证
Nucleic acid test
Blood screening
Performance verification
