Guillon Geraldine, Yearwood Graham, Snipes Casey, Boschi Daniel, Reed Michael R
OraSure Technologies Inc., Bethlehem, PA, USA.
PeerJ. 2018 Feb 28;6:e4430. doi: 10.7717/peerj.4430. eCollection 2018.
The Centers for Disease Control and Prevention (CDC) and many public health jurisdictions continue to advocate for the most sensitive rapid HIV test that is available. Currently, the recommendation is to utilize tests that can detect HIV infection biomarkers within 30 days of infection, when initial immune responses are mounted. The infected patient's IgM response is often used to detect acute infection within a 20-25 days window after infection. This requirement applies to lab-based testing with automated analyzers and rapid, point of care (POC) testing used for screening in a non-clinical setting. A recent study has demonstrated that POC tests using a Protein A-based detection system can detect samples with predominantly HIV-1 IgM reactivity (Moshgabadi et al., 2015). The OraQuick ® Rapid HIV-1/2 Antibody Test (OraQuick ®) also uses Protein A as the detection protein in the antibody-binding colloidal gold conjugate, so it is expected that the OraQuick ® Test will also detect samples with predominantly IgM reactivity. This report definitively demonstrates that the OraQuick ® Test can detect IgM antibodies during an acute infection window period of approximately 20-25 days after infection, and is therefore suitable for use in testing environments requiring adherence to current CDC recommendations.
美国疾病控制与预防中心（CDC）以及许多公共卫生辖区继续倡导使用现有的最灵敏的HIV快速检测方法。目前的建议是采用能够在感染后30天内检测到HIV感染生物标志物的检测方法，此时机体开始产生初始免疫反应。感染患者的IgM反应常被用于在感染后20 - 25天的窗口期内检测急性感染。这一要求适用于使用自动分析仪的实验室检测以及用于非临床环境筛查的快速即时检测（POC）。最近一项研究表明，使用基于蛋白A的检测系统的POC检测能够检测出主要具有HIV-1 IgM反应性的样本（Moshgabadi等人，2015年）。OraQuick® HIV-1/2快速抗体检测（OraQuick®）在抗体结合胶体金偶联物中也使用蛋白A作为检测蛋白，因此预计OraQuick®检测也能检测出主要具有IgM反应性的样本。本报告明确表明，OraQuick®检测能够在感染后约20 - 25天的急性感染窗口期内检测到IgM抗体，因此适用于要求遵循当前CDC建议的检测环境。
