HIV-1 RNA 检测可否作为 HIV 诊断算法中的第二步选择？
Could HIV-1 RNA Testing be an Option as the Second Step in the HIV Diagnostic Algorithm?
机构信息
From the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention.
ORISE, Oak Ridge, Tennessee, USA/ICF, Atlanta, GA.
出版信息
Sex Transm Dis. 2020 May;47(5S Suppl 1):S26-S31. doi: 10.1097/OLQ.0000000000001137.
BACKGROUND
There is benefit to early HIV-1 diagnosis and treatment, but there is no Food and Drug Administration-approved quantitative assay with a diagnostic claim. We compared the performance of the Hologic Aptima HIV-1 Quant (APT-Quant) and Aptima HIV-1 Qual (APT-Qual) assays for diagnostic use and the performance of a diagnostic algorithm consisting of Bio-Rad BioPlex 2200 HIV Ag-Ab assay (BPC) followed by APT-Quant (2-test) compared with BPC followed by Geenius HIV-1/2 supplemental assay (Geenius) with reflex to APT-Qual (3-test).
METHODS
Five hundred twenty-four plasma, which included 419 longitudinal specimens from HIV-1 seroconverters (78 were after initiating antiretroviral therapy [ART]) and 105 from ART-naive persons with established HIV-1 infections, were used to evaluate APT-Quant performance for diagnostic use. Specimens from 200 HIV-negative persons were used to measure specificity. For the algorithm comparison, BPC-reactive specimens were evaluated with the 2-test or 3-test algorithm. McNemar's test was used to compare performance.
RESULTS
The APT-Quant detected more samples early in infection compared with APT-Qual. The APT-Quant specificity was 99.8%. Before ART initiation, the algorithms performed similarly among samples from different stages of infection. After ART initiation, the 3-test algorithm performed significantly better (P = 0.0233).
CONCLUSIONS
The APT-Quant has excellent performance for diagnostic use. The 2-test algorithm works well in ART-naive samples, but its performance decreases after the IgG response is elicited and with ART-induced suppressed viremia. Providing confirmation and viral load assay with 1 test result could be advantageous for patient care. However, additional factors and challenges associated with the implementation of this 2-test algorithm, such as cost, specimen type, and collection need further evaluation.
背景
早期进行 HIV-1 诊断和治疗有益，但目前尚无获得食品和药物管理局（FDA）批准的具有诊断性声明的定量检测方法。我们比较了用于诊断用途的霍洛威克 Aptima HIV-1 Quant（APT-Quant）和 Aptima HIV-1 Qual（APT-Qual）检测以及由 Bio-Rad BioPlex 2200 HIV Ag-Ab 检测（BPC）后进行 APT-Quant（2 测试）与 BPC 后进行 Geenius HIV-1/2 补充检测（Geenius）加 reflex 到 APT-Qual（3 测试）组成的诊断算法的性能。
方法
使用 524 份血浆标本进行研究，包括 419 份来自 HIV-1 血清转化者（78 份在开始抗逆转录病毒治疗[ART]后）和 105 份来自已确诊 HIV-1 感染的未经 ART 治疗者的纵向标本，以评估 APT-Quant 用于诊断的性能。200 份 HIV 阴性者的标本用于测量特异性。对于算法比较，BPC 阳性标本用 2 测试或 3 测试算法进行评估。采用 McNemar 检验比较性能。
结果
与 APT-Qual 相比，APT-Quant 在感染早期检测到更多的样本。APT-Quant 的特异性为 99.8%。在开始 ART 之前，不同感染阶段的样本中算法的性能相似。在开始 ART 后，3 测试算法的性能显著提高（P=0.0233）。
结论
APT-Quant 具有出色的诊断性能。2 测试算法在未经 ART 治疗的样本中效果良好，但在 IgG 反应引发后以及 ART 诱导的病毒血症抑制时，其性能下降。用 1 个检测结果提供确认和病毒载量检测可能对患者护理有利。但是，该 2 测试算法的实施与成本、标本类型和采集相关的其他因素和挑战需要进一步评估。
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