蛋白质印迹法确证为"阴性"的窗口期人类免疫缺陷病毒感染者的筛查试验结果及流行病学特征

Screening test results and epidemiological characteristics of people infected with human immunodeficiency virus in the window period confirmed by Western blotting as"negative"

目的分析蛋白质印迹法确证为"阴性"的窗口期人类免疫缺陷病毒(HIV)感染者的筛查试验结果,以期找到尽快识别窗口期HIV感染者的方法。方法2014年至2021年在上海市浦东新区各级医疗机构经第4代化学发光免疫测定筛查为HIV阳性者的血清(血浆)样本中,纳入蛋白质印迹法确证为"阴性"且第4代酶联免疫吸附测定筛查为阳性者共100名(200份样本)。根据随访结果,将纳入对象分成早期感染组(24例)和未感染组(76名),进行第4代快速诊断试验(RDT)筛查,比较其筛查结果与随访结果的阳性符合情况,并分析早期HIV感染者的流行病学资料。统计学分析采用χ^(2)检验。结果200份样本中,早期感染48份(24.00%)。第4代RDT筛查抗原和(或)抗体阳性共106份,与随访结果为早期感染的符合率为45.28%(48/106),其中第4代RDT筛查抗原阳性与随访结果为早期感染的符合率为100.00%(36/36),高于抗体阳性的24.68%(19/77),差异有统计学意义(χ^(2)=57.49,P<0.001)。24例早期HIV感染者中,19例(79.2%)有急性期症状;6例年龄≥50岁者中仅1例在发生高危性行为前询问过对方HIV感染情况,18例年龄<50岁者中有13例在发生高危性行为前询问过对方HIV感染情况或要求对方检测HIV,差异有统计学意义(χ^(2)=5.71,P=0.017);6例年龄≥50岁者中仅1例主动检测HIV,18例年龄<50岁者中有12例主动检测HIV,差异有统计学意义(χ^(2)=4.53,P=0.033)。结论蛋白质印迹法确证为"阴性"的样本有可能为假阴性,联合第4代筛查试验综合评估能筛查出窗口期感染者。另外,需进一步加强高危人群的宣传教育和监测工作。

Objective To analyze the screening test results of people infected with human immunodeficiency virus(HIV)in the window period confirmed to be"negative"by Western blotting,with a view to finding a way to identify people infected with HIV during the window period as soon as possible.Methods In the serum(plasma)samples of HIV-positive people screened by the fourth-generation chemiluminescent immunoassay in medical institutions at all levels in Pudong New District,Shanghai from 2014 to 2021,a total of 100 people(200 samples)were confirmed as"negative"and the fourth-generation enzyme-linked immunosorbent assay was screened positive.According to the follow-up results,it was divided into the early infection group(24 cases)and the uninfected group(76 people),and the fourth-generation rapid diagnostic test(RDT)was performed.The compliance rates of positive results of screening and follow-up were compared,and the epidemiological data of early HIV infections were analyzed.The chi-square test was used for statistical analysis.Results Of the 200 samples,48(24.00%)were early infected.A total of 106 samples antigens and(or)antibodies were positive by the fourth-generation RDT screening,and the compliance rate with the follow-up results was 45.28%(48/106),of which those of the fourth-generation RDT screening antigen positive and follow-up results were 100.00%(36/36),which was higher than the antibody positive results(24.68%(19/77)).The difference was statistically significant(χ^(2)=57.49,P<0.001).Of the 24 cases of early HIV infections,19(79.2%)had acute symptoms.Only one out of six people≥50 years old had asked about the partner about his HIV status before engaging high-risk sex,and 13 out of 18 people<50 years old had asked the partners about their HIV status or to detect HIV before engaging high-risk sex.The difference was statistically significant(χ^(2)=5.71,P=0.017).Out of the six people≥50 years old,only one actively tested HIV,and 12 out of 18 people<50 years old actively tested HIV,and the difference was statistically significant(χ^(2)=4.53,P=0.033).Conclusions The Western blotting confirmed"negative"samples may be false negative.The comprehensive evaluation which combined with the fourth-generation screening test could help to screen out HIV window infection.In addition,the publicity,education and monitoring of high-risk population need to be further strengthened.