Department of Pathology & Immunology, Washington University School of Medicine in St. Louis, Saint Louis, Missouri, USA.
Department of Pathology, University Hospitals Health System, Cleveland, Ohio, USA.
J Clin Microbiol. 2024 Sep 11;62(9):e0062024. doi: 10.1128/jcm.00620-24. Epub 2024 Aug 16.
Many emergency departments (ED) use rapid human immunodeficiency virus (HIV) antibody tests as screening tools, despite limited sensitivity for detecting acute HIV infections. In a 4-year retrospective analysis of 1,192 patients, we evaluated the performance of a third-generation rapid HIV antibody assay tested at point-of-care (POC, Chembio Sure Check HIV 1/2) against in-lab fourth-generation screening (Abbott Architect Ag/Ab Combo). Compared to complete algorithmic testing, the POC test demonstrated a 92.5% sensitivity (95% CI = 84.6-96.5), 98.1% specificity (95% CI = 97.1-98.8), 99.5% negative predictive value (NPV; 95% CI = 98.8-99.8), and a 77.9% positive predictive value (PPV; 95% CI = 68.6-85.1). Notably, the POC test failed to detect 100% (3/3) of acute HIV infections (defined as Fiebig stage 2) and 3.8% (2/52) established HIV infections, where viral loads were 5.9, 6.7, and >7 log copies/mL. Symptoms such as fever, nausea/vomiting, malaise, headache, and photophobia were significantly associated with acute HIV infections diagnosed in the ED. The rapid HIV antibody test demonstrated high sensitivity, specificity, and NPV in our study population, reaffirming its effectiveness as a valuable screening tool. However, the low PPV and 100% failure to detect acute HIV infections underscore the importance of prioritizing in-lab fourth-generation HIV antigen/antibody combination immunoassays in cases of suspected acute HIV infection to ensure a timely and accurate diagnosis.
许多急诊科(ED)使用快速人类免疫缺陷病毒(HIV)抗体检测作为筛查工具,尽管其检测急性 HIV 感染的敏感性有限。在一项对 1192 例患者的 4 年回顾性分析中,我们评估了床边即时检测(POC,Chembio Sure Check HIV 1/2)的第三代快速 HIV 抗体检测与实验室第四代筛查(雅培 Architect Ag/Ab Combo)的性能。与完整的算法检测相比,POC 检测的敏感性为 92.5%(95%CI=84.6-96.5),特异性为 98.1%(95%CI=97.1-98.8),阴性预测值(NPV)为 99.5%(95%CI=98.8-99.8),阳性预测值(PPV)为 77.9%(95%CI=68.6-85.1)。值得注意的是,POC 检测未能检测到 100%(3/3)的急性 HIV 感染(定义为 Fiebig 阶段 2)和 3.8%(2/52)的已确立 HIV 感染,这些感染的病毒载量分别为 5.9、6.7 和>7log 拷贝/ml。发热、恶心/呕吐、不适、头痛和畏光等症状与 ED 中诊断的急性 HIV 感染显著相关。在我们的研究人群中,快速 HIV 抗体检测显示出高敏感性、特异性和 NPV,再次证实其作为有价值的筛查工具的有效性。然而,低 PPV 和 100%未能检测到急性 HIV 感染突显了在疑似急性 HIV 感染的情况下优先进行实验室第四代 HIV 抗原/抗体组合免疫分析的重要性,以确保及时准确的诊断。