某口腔黏膜渗出液HIV-1/2型抗体检测试剂现场使用效果

Field evaluation on oral mucosal transudate rapid test kit of testing HIV-1/2 antibody

目的对某国产口腔黏膜渗出液艾滋病病毒Ⅰ/Ⅱ型(HIV-1/2)抗体检测试剂进行评价,考核其灵敏度与特异度。方法平行采集353例女性性工作者血液及口腔黏膜渗出液标本,分别使用血液HIV抗体检测试剂和某口腔黏膜渗出液(OMT)HIV-1/2型抗体检测试剂进行现场检测,对比两种检测试剂的检测结果。结果经蛋白免疫印迹试验(WB)检测,62例血液HIV抗体阳性者中,61例OMT检测结果为阳性,该试剂灵敏度为98.39%;291例血液HIV抗体阴性者中,12例OMT检测结果为阳性,263例结果阴性,16例结果为不确定。排除16例OMT结果为不确定的样本后,275例HIV阴性者中,263例OMT结果为阴性,该试剂特异度为95.64%。结论口腔黏膜渗出液HIV-1/2检测试剂灵敏度与特异度均较高,可以应用于现场检测中。

Objective To evaluate the sensitivity and specificity of a HIV-1/2 antibody rapid test which use the oral mucosal transudate specimens. Methods Oral mueosal transudate specimen and serum were collected from 353 female sex workers, the serum were test by ELISA and WB, the OMT were tested by the rapid test kit. Result 62 cases were HIV-positive tested by WB, among these cases 61 were positive by the rapid test kit, the sensitivity of the rapid test kit is 98.39% ; among 291 serum-HIV negative cases, 12 cases were HIV positive by rapid test kit, 263 cases were negative, 16 cases OMT test results were unsure. After exclude the unsure OMT test results, there were 263 HIV negative by rapid test kit of 275 HIV negative cases by ELISA, the specificity of the rapid test kit is 95.64%. Conclusion The oral mucosal transudate rapid test kit had high sensitivity and specificity, it could be used in the field of epidemiology survey.