Mahomed Sharana, Madurai Savathree, Nair Someshni, Cawood Cherie, Eades Joshua, Wang Dan, Subramanian Annalakshmi
Centre for the AIDS Programme of Research in South Africa, CAPRISA, Durban, South Africa.
Department of Medical Microbiology, University of Kwazulu-Natal, Durban, South Africa.
AIDS Res Ther. 2025 Aug 21;22(1):79. doi: 10.1186/s12981-025-00773-1.
Syphilis poses a significant threat to global health, particularly in high-risk populations and resource-limited settings. Despite progress in HIV screening, syphilis testing often lags, exacerbating disparities in healthcare delivery. This study evaluated the clinical performance of the iStatis Syphilis Antibody (Ab) Test in South African point-of-care environments.
A prospective cross-sectional study was conducted with 1,500 enrolled participants across three urban South African sites. The clinical performance of the iStatis Syphilis Antibody (Ab) Test was evaluated using three sample types: capillary blood, EDTA venous whole blood, and plasma. Diagnostic sensitivity and specificity were assessed.
The iStatis test demonstrated excellent diagnostic performance, with sensitivities of 96.40% (capillary blood), 98.80% (venous whole blood), and 99.00% (plasma), and a specificity of 100% across all sample types. A high prevalence of syphilis (33%) was identified. Notably, 90.51% of positive cases were female, and 75.7% of these women were pregnant, highlighting a vulnerable population. The study also revealed a high reinfection rate, suggesting that syphilis can recur relatively quickly post-treatment, underscoring the ongoing transmission challenge.
The iStatis Syphilis Antibody Test is a highly accurate and versatile tool that detects syphilis at different stages using various sample types, making it ideal for use in settings without full laboratory access. The study highlights its potential to improve early diagnosis and control of syphilis, especially in light of high reinfection rates in South Africa. Further research is needed to assess its use in rural areas, long-term performance, and cost-effectiveness to support wider adoption.
梅毒对全球健康构成重大威胁，尤其是在高危人群和资源有限的环境中。尽管在艾滋病毒筛查方面取得了进展，但梅毒检测往往滞后，加剧了医疗服务的不平等。本研究评估了iStatis梅毒抗体检测在南非即时检测环境中的临床性能。
在南非三个城市地点对1500名入组参与者进行了一项前瞻性横断面研究。使用三种样本类型评估iStatis梅毒抗体检测的临床性能：毛细血管血、乙二胺四乙酸（EDTA）静脉全血和血浆。评估诊断敏感性和特异性。
iStatis检测显示出优异的诊断性能，毛细血管血的敏感性为96.40%，静脉全血为98.80%，血浆为99.00%，所有样本类型的特异性均为100%。确定梅毒的患病率很高（33%）。值得注意的是，90.51%的阳性病例为女性，其中75.7%的女性怀孕，这凸显了一个脆弱群体。该研究还揭示了高再感染率，表明梅毒在治疗后可能相对较快复发，突出了持续传播的挑战。
iStatis梅毒抗体检测是一种高度准确且通用的工具，可使用各种样本类型在不同阶段检测梅毒，使其非常适合在没有完整实验室设施的环境中使用。该研究强调了其在改善梅毒早期诊断和控制方面的潜力，特别是鉴于南非的高再感染率。需要进一步研究以评估其在农村地区的使用、长期性能和成本效益，以支持更广泛的采用。
