Analysis and evaluation of hepatitis B test results of blood nucleic acid testing under different screening modes
Objective To evaluate the effectiveness of Roche Cobas s 201 in detecting HBV by analyzing its blood nu-cleic acid testing(NAT)results.Methods The results were grouped according to the enzyme-linked immunosorbent assay(ELISA)and NAT minipool test(MP),NAT individual test(ID)and repeated NAT ID test(rID),and categorized into 4 groups as ELISA+/NAT(ID)+,ELISA+/NAT(rID)+,ELISA-/NAT(ID)+and ELISA-/NAT(rID)+.The data were statistically analyzed to explore whether there was a difference in the detection of reactive results by repeated NAT,and the correlation between cycle threshold(Ct)and nucleic acid detection rate for NAT-reactive samples with different ELISA re-sults.The true infection status of blood donors was further analyzed by supplementary tests,including NAT systems and chemiluminescence serological marker assays using other methodologies.Results A total of 1 691 groups of 766 293 blood donor samples were HBV NAT(MP)+,of which 1 418 groups(83.86%)were detected with reactive results(1 418 HBV NAT+,7 090 NAT-),and there were still 273 groups(16.14%)that remained undetected after repeated testing[a total of 1 638 NAT-,Ct(MP):39.49±3.62].Of the HBV NAT+,881(62.13%)were ELISA+/NAT(ID)+,19(1.34%)were ELISA+/NAT(rID)+,451(31.81%)were ELISA-/NAT(ID)+,and 67(4.72%)were ELISA-/NAT(rID)+.For sam-ples with different ELISA results,difference was found in the detection of HBV by repeated NAT(P<0.05).There was no difference in Ct(ID)values between groups ELISA+/NAT(rID)+and ELISA-/NAT(ID)+,and groups ELISA+/NAT(rID)+and ELISA-/NAT(rID)+(P>0.05),but there were significant differences between other groups compared pair-wise(P<0.05).Supplementary tests were performed on 228 ELISA-/NAT(MP)+(ID)-samples,56(24.56%)were re-active by chemiluminescent detection of HBsAg+and 7(3.07%)by other NAT systems.Among the remaining 221 NAT-samples/donors(96.93%),53(23.98%)HBsAg+donors were likely to have chronic infection,40(18.10%)anti-HBe+and/or anti-HBc+donors might have previous infections,and the remaining 128(57.92%)donors who were non-reactive were NAT(MP)pseudo-reactive,with significant differences in anti-HBs levels \ between groups(P<0.05).Conclusion Repeated NAT has differential detection of donor samples with different reactivity categories or different serologic results,especially within a certain interval,and repeated NAT for ELISA-samples can significantly improve the detection rate.Ct values can assist in assessing the stability and accuracy of the NAT system.For ELISA-/NAT(MP)+(ID)-donors,the com-bination of other highly sensitive assays can reduce the risk of viral residuals and safeguard clinical blood safety.
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