献血者人类免疫缺陷病毒(HIV)实验室检测策略

Laboratory testing strategies for human immunodeficiency virus(HIV)in blood donors

目的探讨献血者血液人类免疫缺陷病毒(HIV)实验室检测策略,为献血者HIV的检测、早期诊断与传播阻断提供参考依据。方法对117987份献血者血液样本使用三代及四代ELISA夹心法HIV检测试剂联合筛查,对单纯三代试剂检测阳性或者三代与四代试剂同时阳性者用Western blot法进行确证检测,对三代、四代试剂检测结果同时阴性者进行HIV核酸检测,仅四代试剂阳性者进行核酸检测,并追踪随访,核酸检测阳性者进行Western blot法确证试验。结果117987份献血者血液样本经不同试剂检测,其中三、四代HIV检测试剂同时检出双阳标本55例,占0.047%,Western blot法确证54例HIV抗体阳性,1例不确定,随访追踪后转为阳性。单纯三代试剂检测阳性者26例,经Western blot法检测HIV抗体阴性24例,抗体不确定样本2例,Western blot法检测带型分别为p24和糖蛋白160(gp160),经追踪随访检测确证为HIV阴性。31例单纯四代HIV检测试剂检测阳性者,经核酸检测发现29例阴性,其中2例核酸阳性,Western blot法确证实验均阴性,2~4周后追踪随访重新抽血复检,转为阳性。三代、四代试剂检测结果同时阴性者进行HIV核酸检测未能检出不合格标本。结论对献血者血液用三、四代ELISA HIV检测试剂联合筛查检测可以起到互补作用,并结合核酸检测及Western blot法检测等补充试验提升了血液供应的安全性,同时,也有助于HIV潜在感染献血者艾滋病的早期诊断预防传播及治疗。

Objective To propose the blood detection strategies for human immunodeficiency virus(HIV)among blood donors,and provide reference for the detection,early diagnosis and transmission blocking of HIV.Methods A total of 117987 blood samples from blood donors were screened using the third-and fourth-generation ELISA HIV detection reagents.Western blot analysis was used to verify the reactive results of the third-generation reagent alone,or both the third-generation and fourth-generation reagents.HIV nucleic acid test was carried out for those with negative test results of the third-and fourth-generation reagents.For those with positive results of the fourth-generation reagent only,nucleic acid test followed by a confirmatory test by Western blot analysis was carried out.Results 117987 blood samples from blood donors were tested by different reagents.Among them,55 were tested positive by both the third-and fourth-generation HIV detection reagents at the same time,accounting for 0.047%and 54 cases were confirmed HIV-positive by Western blot analysis,and 1 case was indeterminate,then turned positive during follow-up testing.26 cases were positive by the third-generation reagent test alone,among which 24 cases were negative and 2 were indeterminate by Western blot analysis.The band types were p24 and gp160 respectively detected by Western blot analysis,and were confirmed to be HiV negative in follow-up testing.31 cases were positive by the fourth-generation HIV reagent alone,among which 29 were negative by nucleic acid test,and 2 were positive according to the nucleic acid test.Western blot analysis was used to verify that the two cases were negative.However,after 2~4 weeks,the results turned positive when the blood sample was retested by Western blot analysis during the follow-up of these two cases.All the specimens that were tested negative by both the third-and fourth-generation HIV reagents were validated negative by HIV nucleic acid test.Conclusion A combined strategy with both third-and fourth-generation HIV detection reagents can play a complementary role in blood screening among blood donors.The application of complementary tests,such as nucleic acid test and Western blot analysis,can further improve the safety of blood supply,thus contributing to the early diagnosis,prevention,transmission and treatment of blood donors potentially infected by HIV.