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首页> 美国卫生研究院文献>Journal of Clinical Microbiology >Multicenter Evaluation of a New Automated Fourth-Generation Human Immunodeficiency Virus Screening Assay with a Sensitive Antigen Detection Module and High Specificity
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Multicenter Evaluation of a New Automated Fourth-Generation Human Immunodeficiency Virus Screening Assay with a Sensitive Antigen Detection Module and High Specificity

机译：具有灵敏抗原检测模块和高特异性的新型自动第四代人类免疫缺陷病毒筛选试验的多中心评估

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Fourth-generation assays for the simultaneous detection of human immunodeficiency virus (HIV) antigen and antibody that were available on the international market until now have antigen detection modules with relatively poor sensitivity and produce a higher rate of false-positive results than third-generation enzyme immunoassays (EIAs). The new Cobas Core HIV Combi EIA with an improved sensitivity for HIV p24 antigen was compared to alternative fourth- and third-generation assays, the p24 antigen test, and HIV type 1 (HIV-1) RNA reverse transcriptase PCR (RT-PCR). A total of 94 seroconversion panels (n = 709 sera), samples from the acute phase of infection after seroconversion (n = 32), anti-HIV-1-positive specimens (n = 730) from patients in different stages of the disease, 462 subtyped samples from different geographical locations, anti-HIV-2-positive sera (n = 302), dilutions of cell culture supernatants (n = 62) from cells infected with different HIV-1 subtypes, selected performance panels from Boston Biomedica Inc., 7,579 unselected samples from blood donors, 303 unselected daily routine samples, 997 specimens from hospitalized patients, and potentially interfering samples (n = 1,222) were tested with Cobas Core HIV Combi EIA. The new assay showed a sensitivity comparable to that of the Abbott HIV-1 AG Monoclonal A for early detection of HIV infection in seroconversion panels. The mean time delay of Cobas Core HIV Combi EIA (last negative sample plus 1 day) in comparison to that for HIV-1 RT-PCR for 87 panels tested with both methods was 2.75 days. The diagnostic window was reduced with Cobas Core HIV Combi EIA by between 3.6 and 5.7 days from that for third-generation assays. The specificities of Cobas Core HIV Combi EIA in blood donors were 99.84 and 99.85% (after repeated testing). Overall, 30 repeatedly reactive false-positive results out of 10,031 HIV-negative samples were obtained with Cobas Core HIV Combi EIA. Our results show that a fourth-generation assay with improved specificity such as Cobas Core HIV Combi EIA is suitable for blood donor screening because of its low number of false positives and because it detects HIV p24 antigen with a sensitivity comparable to that of single-antigen assays.
机译：到现在为止，国际市场上可以同时检测人免疫缺陷病毒（HIV）抗原和抗体的第四代检测方法所具有的抗原检测模块的灵敏度相对较差，且假阳性结果的发生率比第三代酶高免疫测定（EIA）。新的Cobas Core HIV Combi EIA对HIV p24抗原具有更高的敏感性，与其他第四代和第三代检测，p24抗原检测以及HIV 1型（HIV-1）RNA逆转录酶PCR（RT-PCR）进行了比较。共有94例血清学转换组（n = 709血清），来自疾病不同阶段患者的血清学转换后急性期感染样本（n = 32），抗HIV-1阳性标本（n = 730），来自不同地理位置的462个亚型样品，抗HIV-2阳性血清（n = 302），来自感染了不同HIV-1亚型的细胞的细胞培养上清液的稀释液（n = 62），来自Boston Biomedica Inc.使用Cobas Core HIV Combi EIA对来自献血者的7,579份未选择样本，每日303份未选择的日常样本，住院患者的997份样本以及潜在干扰样本（n = 1,222）进行了测试。这项新的检测方法可早期检测血清转化样本中的HIV感染，其灵敏度可与Abbott HIV-1 AG单克隆A媲美。与两种方法测试的87个样本相比，Cobas Core HIV Combi EIA（最后阴性样品加1天）与HIV-1 RT-PCR的平均时间延迟为2.75天。与第三代检测相比，Cobas Core HIV Combi EIA的诊断窗口缩短了3.6至5.7天。献血者中Cobas Core HIV Combi EIA的特异性分别为99.84和99.85％（经过反复测试）。总体而言，使用Cobas Core HIV Combi EIA获得了10031例HIV阴性样本中的30次反复反应的假阳性结果。我们的结果表明，诸如Cobas Core HIV Combi EIA之类具有更高特异性的第四代检测方法适用于献血者筛查，因为它的假阳性率低，并且可以检测HIV p24抗原，其灵敏度可与单一抗原媲美。分析。

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