Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau.
Department of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark.
HIV Med. 2018 Jul;19(6):403-410. doi: 10.1111/hiv.12606. Epub 2018 Mar 24.
Discrimination between HIV-1 and HIV-2 is important to ensure appropriate antiretroviral treatment (ART) and epidemiological surveillance. However, serological tests have shown frequent mistyping when applied in the field. We evaluated two confirmatory tests, INNO-LIA HIV I/II Score and ImmunoComb HIV 1/2 BiSpot, for HIV type discriminatory capacity.
Samples from 239 ART-naïve HIV-infected patients from the Bissau HIV Cohort in Guinea-Bissau were selected retrospectively based on the initial HIV typing performed in Bissau, ensuring a broad representation of HIV types. INNO-LIA results were interpreted by the newest software algorithm, and three independent observers read the ImmunoComb results. HIV-1/HIV-2 RNA and DNA were measured for confirmation.
INNO-LIA results showed 123 HIV-1 positive samples, 69 HIV-2 positive and 47 HIV-1/2 dually reactive. There was agreement between INNO-LIA and HIV-1/HIV-2 RNA and DNA detection, although not all HIV-1/2 dually reactive samples could be confirmed by the nucleic acid results. Overall, the observers found that the ImmunoComb results differed from the INNO-LIA results, with agreements of 90.4, 91.2 and 92.5%, respectively, for HIV-1, HIV-2 and HIV-1/2. The combined kappa-score for agreement between the three observers was 0.955 (z-score 35.1; P < 0.01). Of the HIV-2 mono-reactive samples (INNO-LIA), the three observers interpreted 24.6-31.9% as HIV-1/2 dually infected by ImmunoComb. None of these samples had detectable HIV-1 RNA or DNA.
There was accordance between INNO-LIA calls and nucleic acid results, whereas ImmunoComb overestimated the number of HIV-1/2 dually infected patients. Confirmatory typing is needed for patients diagnosed with HIV-1/2 dual infection by ImmunoComb.
区分 HIV-1 和 HIV-2 对于确保适当的抗逆转录病毒治疗(ART)和流行病学监测非常重要。然而,在现场应用时,血清学检测显示经常出现错误分类。我们评估了两种确认性检测,INNO-LIA HIV I/II Score 和 ImmunoComb HIV 1/2 BiSpot,用于 HIV 型别鉴别能力。
根据在比绍进行的初始 HIV 分型,回顾性选择了来自几内亚比绍比绍 HIV 队列的 239 名未接受 ART 的 HIV 感染患者的样本,确保了 HIV 型别的广泛代表性。INNO-LIA 结果由最新软件算法进行解释,三位独立观察者读取 ImmunoComb 结果。测量 HIV-1/HIV-2 RNA 和 DNA 以进行确认。
INNO-LIA 结果显示 123 份 HIV-1 阳性样本、69 份 HIV-2 阳性样本和 47 份 HIV-1/2 双重反应样本。INNO-LIA 结果与 HIV-1/HIV-2 RNA 和 DNA 检测结果一致,尽管并非所有 HIV-1/2 双重反应样本都能通过核酸结果得到确认。总体而言,观察者发现 ImmunoComb 结果与 INNO-LIA 结果不同,HIV-1、HIV-2 和 HIV-1/2 的一致性分别为 90.4%、91.2%和 92.5%。三位观察者之间的一致性的联合 Kappa 评分 0.955(z 分数 35.1;P <0.01)。在 INNO-LIA 检测的 HIV-2 单阳性样本中,三位观察者中有 24.6-31.9%的样本被 ImmunoComb 解释为 HIV-1/2 双重感染。这些样本均无可检测到的 HIV-1 RNA 或 DNA。
INNO-LIA 结果与核酸结果一致,而 ImmunoComb 高估了 HIV-1/2 双重感染患者的数量。对于被 ImmunoComb 诊断为 HIV-1/2 双重感染的患者,需要进行确认性分型。