Roche Molecular Systems, Pleasanton, California, USA.
Roche Molecular Systems, Basel, Switzerland.
J Clin Microbiol. 2021 Jun 18;59(7):e0303020. doi: 10.1128/JCM.03030-20.
Human immunodeficiency virus types 1 and 2 (HIV-1 and HIV-2) diagnostic testing algorithms recommended by the Centers for Disease Control involve up to three tests and rely mostly on detection of viral antigen and host antibody responses. HIV-1 p24 antigen/HIV-1/HIV-2 antibody-reactive specimens are confirmed with an immunochromatographic HIV-1/HIV-2 antibody differentiation assay, and negative or indeterminate results from the differentiation assay are resolved by an HIV-1-specific nucleic acid amplification test (NAT). The performance of a proposed alternative algorithm using the cobas HIV-1/HIV-2 qualitative NAT as the differentiation assay was evaluated in subjects known to be infected with HIV-1 ( = 876) or HIV-2 ( = 139), at low ( = 6,017) or high ( = 1,020) risk of HIV-1 infection, or at high-risk for HIV-2 infection ( = 498) (study A). The performance of the cobas HIV-1/HIV-2 qualitative test was also evaluated by comparison to an HIV-1 or HIV-2 alternative NAT (study B). The HIV-1 and HIV-2 overall percent agreements (OPA) in study A ranged from 95% to 100% in all groups. The positive percent agreements (PPA) for HIV-1 and HIV-2 were 100% (876/876) and 99.4% (167/168), respectively, for known positive groups. The negative percent agreement in the HIV low-risk group was 100% for both HIV-1 and HIV-2. In study B, the HIV-1 and HIV-2 OPA ranged from 99% to 100% in all groups evaluated ( = 183 to 1,030), and the PPA for HIV-1 and HIV-2 were 100% and 99.5%, respectively, for known positive groups. The cobas HIV-1/HIV-2 qualitative assay can discriminate between HIV-1 and HIV-2 based on HIV RNA and can be included in an alternative diagnostic algorithm for HIV.
人类免疫缺陷病毒 1 型和 2 型（HIV-1 和 HIV-2）诊断检测算法由疾病控制中心推荐，包括多达三种检测方法，主要依赖于病毒抗原和宿主抗体反应的检测。HIV-1 p24 抗原/HIV-1/HIV-2 抗体反应性标本通过免疫层析 HIV-1/HIV-2 抗体鉴别检测进行确认，而鉴别检测的阴性或不确定结果则通过 HIV-1 特异性核酸扩增检测（NAT）来解决。在已知感染 HIV-1（ = 876）或 HIV-2（ = 139）、HIV-1 感染低（ = 6,017）或高（ = 1,020）风险或 HIV-2 感染高风险（ = 498）的受试者中，评估了使用 cobas HIV-1/HIV-2 定性 NAT 作为鉴别检测的拟议替代算法的性能（研究 A）。通过与 HIV-1 或 HIV-2 替代 NAT 的比较，还评估了 cobas HIV-1/HIV-2 定性检测的性能（研究 B）。在研究 A 中，各组 HIV-1 和 HIV-2 的总体符合率（OPA）均为 95%至 100%。已知阳性组的 HIV-1 和 HIV-2 的阳性符合率（PPA）均为 100%（876/876）和 99.4%（167/168）。HIV 低风险组的阴性符合率对于 HIV-1 和 HIV-2 均为 100%。在研究 B 中，所有评估组（ = 183 至 1,030）的 HIV-1 和 HIV-2 的 OPA 均为 99%至 100%，已知阳性组的 HIV-1 和 HIV-2 的 PPA 分别为 100%和 99.5%。cobas HIV-1/HIV-2 定性检测可以根据 HIV RNA 区分 HIV-1 和 HIV-2，可以纳入 HIV 的替代诊断算法。
