Luo Wei, Davis Geoff, Li LiXia, Shriver M Kathleen, Mei Joanne, Styer Linda M, Parker Monica M, Smith Amanda, Paz-Bailey Gabriela, Ethridge Steve, Wesolowski Laura, Owen S Michele, Masciotra Silvina
Centers for Disease Control and Prevention, Atlanta, GA, USA.
Bio-Rad Laboratories, Redmond, WA, USA.
J Clin Virol. 2017 Jun;91:84-89. doi: 10.1016/j.jcv.2017.03.011. Epub 2017 Mar 20.
FDA-approved antigen/antibody combo and HIV-1/2 differentiation supplemental tests do not have claims for dried blood spot (DBS) use. We compared two DBS-modified protocols, the Bio-Rad GS HIV Combo Ag/Ab (BRC) EIA and Geenius™ HIV-1/2 (Geenius) Supplemental Assay, to plasma protocols and evaluated them in the CDC/APHL HIV diagnostic algorithm.
BRC-DBS p24 analytical sensitivity was calculated from serial dilutions of p24. DBS specimens included 11 HIV-1 seroconverters, 151 HIV-1-positive individuals, including 20 on antiretroviral therapy, 31 HIV-2-positive and one HIV-1/HIV-2-positive individuals. BRC-reactive specimens were tested with Geenius using the same DBS eluate. Matched plasma specimens were tested with BRC, an IgG/IgM immunoassay and Geenius. DBS and plasma results were compared using the McNemar's test. A DBS-algorithm applied to 348 DBS from high-risk individuals who participated in surveillance was compared to HIV status based on local testing algorithms.
BRC-DBS detects p24 at a concentration 18 times higher than in plasma. In seroconverters, BRC-DBS detected more infections than the IgG/IgM immunoassay in plasma (p=0.0133), but fewer infections than BRC-plasma (p=0.0133). In addition, the BRC/Geenius-plasma algorithm identified more HIV-1 infections than the BRC/Geenius-DBS algorithm (p=0.0455). The DBS protocols correctly identified HIV status for established HIV-1 infections, including those on therapy, HIV-2 infections, and surveillance specimens.
The DBS protocols exhibited promising performance and allowed rapid supplemental testing. Although the DBS algorithm missed some early infections, it showed similar results when applied to specimens from a high-risk population. Implementation of a DBS algorithm would benefit testing programs without capacity for venipuncture.
美国食品药品监督管理局（FDA）批准的抗原/抗体联合检测以及HIV-1/2鉴别补充检测均未声明可用于干血斑（DBS）检测。我们比较了两种经DBS改良的检测方案，即伯乐GS HIV联合抗原/抗体（BRC）酶免疫分析和Geenius™ HIV-1/2（Geenius）补充检测，并与血浆检测方案进行比较，同时在疾病控制与预防中心（CDC）/美国公共卫生实验室协会（APHL）的HIV诊断算法中对它们进行评估。
通过对p24进行系列稀释来计算BRC-DBS p24的分析灵敏度。DBS样本包括11例HIV-1血清转化者、151例HIV-1阳性个体（其中20例接受抗逆转录病毒治疗）、31例HIV-2阳性个体以及1例HIV-1/HIV-2双阳性个体。对BRC反应性样本使用相同的DBS洗脱液进行Geenius检测。对匹配的血浆样本进行BRC、IgG/IgM免疫分析以及Geenius检测。使用McNemar检验比较DBS和血浆检测结果。将应用于348份来自参与监测的高危个体的DBS样本的DBS算法与基于当地检测算法得出的HIV状态进行比较。
BRC-DBS检测p24的浓度比血浆中的高18倍。在血清转化者中，BRC-DBS检测到的感染病例比血浆中的IgG/IgM免疫分析更多（p = 0.0133），但比BRC-血浆检测到的感染病例更少（p = 0.0133）。此外，BRC/Geenius-血浆算法识别出的HIV-1感染病例比BRC/Geenius-DBS算法更多（p = 0.0455）。DBS检测方案能够正确识别已确诊的HIV-1感染（包括接受治疗者）、HIV-2感染以及监测样本的HIV状态。
DBS检测方案表现出良好的性能，可实现快速补充检测。尽管DBS算法遗漏了一些早期感染病例，但应用于高危人群样本时显示出相似的结果。实施DBS算法将使无静脉穿刺能力的检测项目受益。
