摘要
目的验证新引进的某核酸单检系统的检测性能,确认其主要试验参数是否满足血液筛查实验室的预期要求。方法采用标准血清和已知阴性结果的HBV DNA、HCV RNA、HIV RNA血浆,通过倍比稀释至不同倍数(0.5~3.0倍)的该检测系统最低检测限(Limit of Detection,LoD)标本,分别进行单样本核酸检测HBV DNA、HCV RNA、HIV-1 RNA,进而验证其分析灵敏度、稳定性、正确性和抗干扰能力等性能。结果对该系统进行3×LoD浓度HBV DNA、HCV RNA、HIV-1 RNA分析灵敏度验证,其阳性检出率均为100%,1×LoD的阳性检出率为95.0%~100%,0.5×LoD的阳性检出率为70.0%~90.0%;批内精密度变异系数为2.07%~2.62%,批间精密度变异系数为2.33%~2.88%;检测10份国家临检中心室间质评标本的结果正确率为100%;严重溶血和脂肪血标本对3×LoD浓度HBV DNA、HCV RNA、HIV-1 RNA检测无影响,验证任一2×LoD浓度HBV DNA、HCV RNA、HIV-1 RNA是否受高浓度其他病毒抑制的不同组合检测,结果均无影响;与某进口核酸混样检测系统平行比对2041份ELISA检测阴性献血者标本,阳性检出率1.67%(34/2041)略高于混检系统的1.66%(33/2041)(χ^(2)=0.015,P>0.05)。结论该单检核酸系统在分析灵敏度、稳定性、正确性和抗干扰能力等性能符合要求,可用于献血者血液筛查。
Objective To verify the detection performance of a newly introduced individual donation(ID)nucleic acid detection(NAT)system,and to confirm whether its main test parameters meet the expected requirements of blood screening.Methods Standard serum and plasma negative for HBV DNA,HCV RNA,and HIV RNA were diluted to different multiples samples(0.5~3 times)of the detection system′s limit of detection(LoD).These samples were conducted NAT test for HBV DNA,HCV RNA and HIV-1 RNA,to verify the testing sensitivity,stability,accuracy and anti-interference ability.Results The sensitivity of 3×LoD concentration of HBV DNA,HCV RNA and HIV-1 RNA was tested by the system,and the yielding rates were all 100%,with 1×LoD at 95.0%~100%and 0.5×LoD at 70.0%~90.0%.The intra-assay and inter-assay precision variation coefficient was 2.07%~2.62%and 2.33%~2.88%,respectively.The accuracy of 10 external quality assessment samples of National Center for Clinical Laboratories was 100%.Severe hemolysis and fatty blood had no effect on the detection of samples with 3×LoD concentration of HBV DNA,HCV RNA and HIV-1 RNA.Any combinations by samples with 2×LoD concentration of HBV DNA,HCV RNA,and HIV-1 RNA were not inhibited by high concentrations of other viruses.Among 2041 sero-negative samples from blood donor,the NAT yield of this system was 1.67%(34/2041),which was a little bit higher than that of a imported minipool system(1.66%,33/2041)(P>0.05).Conclusion The ID-NAT system can meet the requirements in terms of sensitivity,stability,accuracy and anti-interference ability,and can be used for blood screening of blood donors.
作者
魏润葵
余霖
陈少彬
邓妙玲
陈静文
何子毅
WEI Runkui;YU Lin;CHEN Shaobin;DENG Miaoling;CHEN Jingwen;HE Ziyi(Dongguan Central Blood Station,Dongguan 523900,China)
出处
《中国输血杂志》
CAS
2022年第4期449-452,共4页
Chinese Journal of Blood Transfusion
关键词
单检
核酸检测
检测性能
血液筛查
individual donation detection
nucleic acid test
test performance
blood screening
