Limitations of rapid HIV-1 tests during screening for trials in Uganda: diagnostic test accuracy study
Limitations of rapid HIV-1 tests during screening for trials in Uganda: diagnostic test accuracy study
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DOI：
10.1136/bmj.39210.582801.be
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发表时间：
2007-07-28
影响因子：
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通讯作者：
Wawer, Maria J.
中科院分区：
文献类型：
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作者：
Gray, Ronald H.;Makumbi, Fredrick;Wawer, Maria J.
目的评价HIV-1快速检测方法的局限性。设计诊断检测准确度研究。以乌干达农村拉凯为背景，对1517名15-49岁的受试者进行包皮环切术预防HIV试验。主要观察指标三种快速检测方法对HIV快速检测的敏感性、特异性、阴性预测值和阳性预测值，并与酶免疫法和Western blotting的结果进行比较。敏感性为97.7%。在639个样本中，如果样本显示HIV阳性，则编码阳性条带的强度，该算法的特异性(94.1%)和阳性预测值(74.0%)都很低。排除弱阳性带37例(5.8%)，提高了诊断的特异度(99.6%)和阳性预测值(97.7%)。常规使用快速检测的程序应使用标准的血清学检测来进行质量控制。
Objective To evaluate the limitations of rapid tests for HIV-1.Design Diagnostic test accuracy study.Setting Rural Rakai, Uganda.Participants 1517 mates aged 15-49 screened for trials of circumcision for HIV prevention.Main outcome measures Sensitivity, specificity, negative predictive values, and positive predictive values of an algorithm using three rapid tests for HIV, compared with the results of enzyme immunoassay and western blotting as the optimal methods.Results Rapid test results were evaluated by enzyme immunoassay and western blotting. Sensitivity was 97.7%. Among 639 samples where the strength of positive bands was coded if the sample showed positivity for HIV, the algorithm had low specificity (94.1%) and a low positive predictive value (74.0%). Exclusion of 37 samples (5.8%) with a weak positive band improved the specificity (99.6%) and positive predictive value (97.7%.).Conclusion Weak positive bands on rapid tests for HIV should be confirmed by enzyme immunoassay and western blotting before disclosing the diagnosis. Programmes using rapid tests routinely should use standard serological assays for quality control.