Stafylis Chrysovalantis, Klausner Jeffrey D
Division of Infectious Diseases, Department of Medicine, UCLA David Geffen School of Medicine, Los Angeles, California, United States of America.
PLoS One. 2017 Aug 28;12(8):e0183944. doi: 10.1371/journal.pone.0183944. eCollection 2017.
Fourth generation assays detect simultaneously antibodies for HIV and the p24 antigen, identifying HIV infection earlier than previous generation tests. Previous studies have shown that the Alere Determine HIV-1/2 Combo has lower than anticipated performance in detecting antibodies for HIV and the p24 antigen. Furthermore, there are currently very few studies evaluating the performance of Standard Diagnostics BIOLINE HIV Ag/Ab Combo.
To evaluate the performance of the Alere Determine HIV-1/2 Combo and the Standard Diagnostics BIOLINE HIV Ag/Ab Combo in a panel of frozen serum samples.
The testing panel included 133 previously frozen serum specimens from the UCLA Clinical Microbiology & Immunoserology laboratory. Reference testing included testing for HIV antibodies by a 3rd generation enzyme immunoassay followed by HIV RNA detection. Antibody negative and RNA positive sera were also tested by a laboratory 4th generation HIV Ab/Ag enzyme immunoassay.
Reference testing yielded 97 positives for HIV infection and 36 negative samples. Sensitivity of the Alere test was 95% (88-98%), while the SD Bioline sensitivity was 91% (83-96%). Both assays showed 100% (90-100%) specificity. No indeterminate or invalid results were recorded. Among 13 samples with acute infection (HIV RNA positive, HIV antibody negative), 12 were found positive by the first assay and 8 by the second. The antigen component of the Alere assay detected 10 acute samples, while the SD Bioline assay detected only one.
Both rapid assays showed very good overall performance in detecting HIV infection in frozen serum samples, but further improvements are required to improve the performance in acute infection.
第四代检测方法可同时检测HIV抗体和p24抗原，比上一代检测方法能更早地识别HIV感染。先前的研究表明，Alere Determine HIV-1/2组合检测在检测HIV抗体和p24抗原方面的表现低于预期。此外，目前评估标准诊断BIOLINE HIV Ag/Ab组合检测性能的研究非常少。
评估Alere Determine HIV-1/2组合检测和标准诊断BIOLINE HIV Ag/Ab组合检测在一组冷冻血清样本中的性能。
检测组包括来自加州大学洛杉矶分校临床微生物学与免疫血清学实验室的133份先前冷冻的血清标本。参考检测包括通过第三代酶免疫法检测HIV抗体，随后进行HIV RNA检测。抗体阴性且RNA阳性的血清也通过实验室第四代HIV Ab/Ag酶免疫法进行检测。
参考检测得出97份HIV感染阳性样本和36份阴性样本。Alere检测的灵敏度为95%（88%-98%），而SD Bioline检测的灵敏度为91%（83%-96%）。两种检测方法的特异性均为100%（90%-100%）。未记录到不确定或无效结果。在13份急性感染样本（HIV RNA阳性，HIV抗体阴性）中，第一种检测方法检测出12份阳性，第二种检测方法检测出8份阳性。Alere检测的抗原成分检测出10份急性样本，而SD Bioline检测仅检测出1份。
两种快速检测方法在检测冷冻血清样本中的HIV感染方面总体表现良好，但在急性感染检测性能方面仍需进一步改进。
