Application Value of Enzyme-linked Immunosorbent Assay in HTLV Screening Results of Voluntary Blood Donors in Pingxiang City
Objective To study the application value of enzyme-linked immunosorbent assay in human T-lymphocyte virus(HTLV)screening results of unpaid blood donors in Pingxiang City.Methods A total of 12 172 voluntary blood donors from March 2022 to June 2023 in our station were selected as the research objects.Firstly,enzyme-linked immunosorbent assay(ELISA)was used to screen HTLV.The initial positive samples were retested by two holes.The blood nucleic acid of the retested positive samples was extracted,and the viral nucleic acid amplification test was carried out by fluorescence quantitative nucleic acid amplification(PCR)instrument.The sensitivity and specificity of enzyme-linked immunosorbent assay for screening HTLV were analyzed by ROC curve.Kappa test was used to analyze the consistency between enzyme-linked immunosorbent assay for screening HTLV and fluorescence quantitative PCR confirmation results.Results Totally 29 positive samples were found in 12 172 voluntary blood donors by enzyme-linked immunosorbent assay,and the positive rate was 0.24%.Three positive samples were confirmed by fluorescence quantitative PCR,and the positive rate was 0.0247%.The sensitivity and specificity of enzyme-linked immunosorbent assay for screening HTLV were 66.67%and 99.78%,respectively.The ROC curve showed that AUC=1(P<0.05),and the maximum Youden index was 0.99.The positive rate of HTLV screening by enzyme-linked immunosorbent assay was generally consistent with the positive results confirmed by fluorescence quantitative PCR(Kappa=0.257,P=0.025).Conclusion Enzyme-linked immunosorbent assay has certain value in screening HTLV in voluntary blood donors,but the sensitivity is relatively low,and there are some missed diagnosis and misdiagnosis.Therefore,the clinical should be combined with nucleic acid test method for further detection of blood samples,in order to improve the accuracy of the test,so as to ensure the safety of blood transfusion.