Centro Internacional de Entrenamiento e Investigaciones Médicas - CIDEIM, Cali, Colombia.
Universidad Icesi, Cali, Colombia.
PLoS One. 2023 Mar 9;18(3):e0282492. doi: 10.1371/journal.pone.0282492. eCollection 2023.
There is insufficient evidence supporting the use of rapid diagnostic tests (RDTs) for syphilis in people living with HIV (PLWH). We evaluated the diagnostic performance of two commercially available RDTs (Bioline and Determine) in PLWH in Cali, Colombia.
A cross-sectional field validation study on consecutive adults with confirmed HIV diagnosis attending three outpatient clinics. Both RDTs were performed on capillary blood (CB), obtained by finger prick, and sera, by venipuncture. A combination of treponemal enzyme linked immunosorbent assay (ELISA) and Treponema pallidum haemagglutination assay (TPHA) on serum samples was the reference standard. Rapid plasma reagin (RPR) and clinical criteria were added to define active syphilis. Sensitivity and specificity, predictive values and likelihood ratios (LR) of RDTs were estimated with their corresponding 95% confidence interval (95% CI). Stratified analyses by sample type, patient characteristics, non-treponemal titers, operator and re-training were performed.
244 PLWH were enrolled, of whom 112 (46%) had positive treponemal reference tests and 26/234 (11.1%) had active syphilis. The sensitivities of Bioline on CB and sera were similar (96.4% vs 94.6%, p = 0.6). In contrast, Determine had a lower sensitivity on CB than sera (87.5% vs 99.1%, p<0.001). Sensitivities were lower in PLWH not receiving ART (Bioline 87.1% and Determine 64.5%, p<0.001) and for one of the operators (Bioline 85% and Determine 60%, p<0.001). Specificities of the RDTs were > 95% in most analyses. Predictive values were 90% or higher. For active syphilis, the RDTs showed a similar performance pattern but with decreased specificities.
The studied RDTs have an excellent performance in PLWH to screen for syphilis and potentially for active syphilis, yet Determine performs better on sera than CB. Patient characteristics and potential difficulties operators may face in acquiring enough blood volume from finger pricks should be considered for the implementation and the interpretation of RDTs.
目前尚缺乏支持在 HIV 感染者（PLWH）中使用快速诊断检测（RDT）检测梅毒的证据。我们在哥伦比亚卡利评估了两种市售 RDT（Bioline 和 Determine）在 PLWH 中的诊断性能。
这是一项在连续确诊 HIV 的成年门诊患者中进行的横断面现场验证研究。两种 RDT 均在毛细血管血（CB）上进行，通过指尖采血获得，在血清中通过静脉穿刺采血获得。血清样本联合梅毒螺旋体酶联免疫吸附试验（ELISA）和梅毒螺旋体血凝试验（TPHA）作为参考标准。快速血浆反应素（RPR）和临床标准被添加到定义活动性梅毒。用相应的 95%置信区间（95%CI）估计 RDT 的敏感性和特异性、预测值和似然比（LR）。按样本类型、患者特征、非梅毒螺旋体滴度、操作者和再培训进行分层分析。
共纳入 244 名 PLWH，其中 112 名（46%）梅毒螺旋体参考检测阳性，26/234 名（11.1%）患有活动性梅毒。Bioline 在 CB 和血清上的敏感性相似（96.4% vs 94.6%，p=0.6）。相比之下，Determine 在 CB 上的敏感性低于血清（87.5% vs 99.1%，p<0.001）。未接受抗逆转录病毒治疗（ART）的 PLWH（Bioline 87.1%和 Determine 64.5%，p<0.001）和一位操作者（Bioline 85%和 Determine 60%，p<0.001）的敏感性较低。在大多数分析中，RDT 的特异性>95%。预测值在 90%或更高。对于活动性梅毒，RDT 显示出相似的性能模式，但特异性降低。
在 PLWH 中，研究的 RDT 对筛查梅毒具有出色的性能，并且可能对筛查活动性梅毒也具有出色的性能，但在 CB 上，Determine 的性能优于血清。应考虑患者特征和操作者在从指尖获得足够血量方面可能面临的潜在困难，以实施和解释 RDT。
