摘要目的探讨口腔黏膜渗出液(OMT)快速诊断试剂与酶联免疫吸附试验(ELISA)试剂检测不同人群HIV-1抗体的一致性.方法对已经过生物梅里埃ELISA试剂检测血清HIV-1抗体阳性并经蛋白印迹(WB)试验确诊的HIV感染者200例(HIV阳性组),和经过生物梅里埃ELISA试剂检测血清HIV-1抗体阴性的健康人群600例(HIV阴性组)采集OMT标本,使用OMT快速诊断试剂进行HIV-1抗体检测.同时评价口腔黏膜渗出液快速诊断试剂在实际应用中的影响因素.结果 HIV阳性组200例中198例OMT标本检测为阳性,其中192例(96%)检测线清楚,易做阳性结果判断.4例(2%)"模糊",2例(1%)"很模糊",需经专业人员判断;2例(1%)检测线"看不见",为阴性.HIV阴性组600例OMT标本检测HIV抗体全为阴性.结论口腔黏膜渗出液快速诊断试剂与生物梅里埃血清ELISA诊断试剂检测HIV-1抗体相比,在HIV阳性标本中检测一致性为99.0%,在HIV阴性标本中检测一致性为100%,总体一致性为99.75%.

abstractsObjective To evaluate the consistence in the detection of antibodies against HIV-1 between a new rapid test using oral mucosal transudate (OMT) samples and ELISA using serum samples. Methods Two-hundred patients who were positive for anti-HIV-1 antibodies by serum ELISA and confirmed by Western blot to be infected with HIV, and 600 healthy human controls negative for anti-HIV-1 antibodies by serum ELISA, were eligible for this study. OMT samples were collected from these subjects and subjected to a rapid test for anti-HIV-1 antibodies. The factors influencing the performance of the rapid test were analyzed. Results Of the 200 OMT specimens from HIV-infected patients, 198 showed positive reaction, 2 showed negative reaction. Among the 198 positive reactions, 192 (96%) were "clear" and easy to make decisions, 4 (2%) were "faint", 2(1%) were "very faint" and required professionals to make decisions. The rapid test was negative in all the 600 OMT specimens from the control group. Conclusions The consistence in the detection of anti-HIV-1 antibodies between the OMT rapid test and serum ELISA was 99% in HIV-positive specimens, 100% in HIV-negative specimens, and 99.75% in all the specimens.