Ciglenecki Iza, Ntshalintshali Nombuso, Mukooza Esther, Lekelem Skinner, Mavimbela Mpumelelo, Dlamini Sindisiwe, Dube Lenhle, Mabuza Nomvuyo, Haile Melat, Ellman Tom, Flores Antonio, Keiser Olivia, Matse Sindy, de la Tour Roberto, Calmy Alexandra, Kerschberger Bernhard
Médecins Sans Frontières (MSF), Geneva, Switzerland.
Institute of Global Health, University of Geneva, Geneva, Switzerland.
J Int AIDS Soc. 2025 Jul;28(7):e26517. doi: 10.1002/jia2.26517.
The diagnosis of acute HIV infection (AHI) is challenging in routine settings because it cannot be detected by routine third-generation antibody rapid diagnostic tests (RDTs). The current fourth-generation antibody/antigen RDT, Determine™ HIV Early Detect, has demonstrated high sensitivity in laboratory studies, but field evaluations at the point of care are lacking. We nested a diagnostic accuracy study within a larger study of the burden of sexually transmitted infections in rural Eswatini.
Adults were enrolled at six routine HIV testing sites (HTS) in the Shiselweni region between June 2022 and April 2023. Determine™ HIV Early Detect was performed by HTS counsellors in parallel with routine HIV testing using a finger-prick blood sample. The reference test was HIV viral load (VL) in the plasma sample, performed on the Xpert platform in the central laboratory. AHI was defined as a negative or discordant HIV test result according to the national serial RDT algorithm and an HIV VL >10,000 copies/ml, or two consecutive HIV VL measurements between the lower limit of detection (40 copies/ml) and 10,000 copies/ml. Established HIV infection was defined as a positive serial RDT test, and overall HIV infection as either established HIV infection or AHI.
One thousand one hundred and sixty-three participants had all test results available; 49 (4.2%) were diagnosed with HIV (39 with established HIV according to the serial RDT algorithm and 10 with AHI). AHI prevalence among participants with HIV negative or discordant routine RDT results was 0.9% (10/1124). The sensitivity of Determine™ HIV Early Detect to detect overall HIV infection was 83.7% (95% CI 70.3-92.7) and to detect AHI was 20% (95% CI 2.5-55.6%); the specificity was equally high for both 99.8% (95% CI 99.4-100).
The low sensitivity of Determine™ HIV Early Detect to detect AHI when performed at the point of care using finger-prick blood samples in our study contrasts with other published evaluations from laboratory settings and highlights the importance of field evaluations of the commonly used diagnostic tests.
急性HIV感染（AHI）的诊断在常规环境中具有挑战性，因为常规第三代抗体快速诊断检测（RDT）无法检测到它。目前的第四代抗体/抗原RDT——Determine™ HIV Early Detect，在实验室研究中已显示出高灵敏度，但缺乏在护理点的现场评估。我们在一项关于斯威士兰农村地区性传播感染负担的更大规模研究中纳入了一项诊断准确性研究。
2022年6月至2023年4月期间，在希塞尔韦尼地区的六个常规HIV检测点（HTS）招募成年人。HTS的咨询人员使用手指采血样本，将Determine™ HIV Early Detect与常规HIV检测同时进行。参考检测是在中央实验室的Xpert平台上对血浆样本进行HIV病毒载量（VL）检测。根据国家连续RDT算法，AHI被定义为HIV检测结果为阴性或不一致，且HIV VL>10,000拷贝/ml，或两次连续HIV VL测量值在检测下限（40拷贝/ml）和10,000拷贝/ml之间。确诊的HIV感染被定义为连续RDT检测呈阳性，总体HIV感染定义为确诊的HIV感染或AHI。
1163名参与者的所有检测结果均可用；49人（4.2%）被诊断为HIV（根据连续RDT算法，39人确诊为HIV，10人诊断为AHI）。常规RDT结果为阴性或不一致的参与者中AHI患病率为0.9%（10/1124）。Determine™ HIV Early Detect检测总体HIV感染的灵敏度为83.7%（95%CI 70.3 - 92.7），检测AHI的灵敏度为20%（95%CI 2.5 - 55.6%）；两者的特异性均同样高，为99.8%（95%CI 99.4 - 100）。
在我们的研究中，使用手指采血样本在护理点进行检测时，Determine™ HIV Early Detect检测AHI的灵敏度较低，这与其他已发表的实验室环境评估结果形成对比，并突出了对常用诊断检测进行现场评估的重要性。
