烟台市86429例献血者人类嗜T淋巴细胞病毒感染情况分析及其检测方法对比

Analysis on human T-lymphotropic lymphotropic virus infection in 86429 blood donors and comparison of detection methods in Yantai City

目的调查山东省烟台市无偿献血人群中人类嗜T淋巴细胞病毒(HTLV)的感染情况,评估ELISA检测与蛋白印迹法确证试验对确证HTLV阳性结果的差异。方法收集2016-2021年烟台市中心血站无偿献血者的血液样本86429份。采用国产双抗原夹心法ELISA试剂进行抗-HTLV-1、抗-HTLV-2筛查,对ELISA检测的HTLV初筛阳性样本进行双孔复试,将复试阳性标本送国家卫生健康委员会临床检验中心实验室使用蛋白印迹法进行确证试验。对比ELISA检测与蛋白印迹法确证试验的HTLV阳性结果。结果86429份献血者血液标本经ELISA检测出27份ELISA反应性标本,初筛阳性率为0.03%(27/86429);S/CO值≥5为7份,S/CO值3~5为7份,S/CO值1~3为13份。蛋白印迹法确证试验确证阳性1份,不确定4份,阴性22份。经确证阴性的22份样本S/CO值与确证阳性样本S/CO值差异有统计学意义(Z=1.58,P=0.049),而4份确证不确定与1份确证阳性样本S/CO值差异无统计学意义(W=10,P=0.40)。ELISA初筛阳性检出率与经蛋白印迹试验确证阳性检出率差异有统计学意义(Fisher′s确切检验,P=0.008)。结论烟台市无偿献血群体HTLV感染率处于低水平。ELISA检测抗-HTLV存在较高的假阳性,有必要进行确证试验。

Objective To investigate the prevalence of human T-cell lymphotropic virus(HTLV)infection among voluntary nonremunerated blood doners(VNRBD)in Yantai city,Shandong province,and to evaluate the difference between ELISA test and Western blotting confirmatory test for HTLV positive results certification.Methods A total of 86429 blood samples were collected from VNRBD in Yantai Central Blood Station from 2016 to 2021.Domestic double antigen sandwich ELISA reagent was used for the Anti-HTLV-1 and anti-HTLV-2 screening,and the positive samples of HTLV were retested by double wells.The positive samples of retest were sent to the National Center for Clinical Laboratories(NCCL)for confirmatory test with Western blotting method.The results of ELISA and Western blotting were compared.Results The 86429 blood specimens from donors were tested by ELISA and 27 ELISA-reactive specimens were detected,resulting in an initial positive rate of 0.03%(27/86429);there were 7 samples with S/CO≥5,7 samples with S/CO 3-5,and 13 samples with S/CO 1-3.The Western blotting confirmatory test confirmed 1 positive case,4 uncertain cases and 22 negative cases.The difference between the S/CO values of the 22 samples that were confirmed negative and the S/CO values of the samples that were confirmed positive was statistically significant(Z=1.58,P=0.049),while there was no statistically significant between the S/CO values of 4 uncertain samples and 1 confirmed positive sample(W=10,P=0.40).The difference between the positive rate of ELISA screening and the positive rate of Western blotting screening has a statistically significant(Fisher′s exact test,P=0.008).Conclusion The HTLV infection rate of VNRBD in Yantai cit is at a low level.There is a relatively high false-positive rate in Anti-HTLV test by ELISA and it is necessary to complete confirmatory test.