Infectious Diseases and Immunity in Global Health, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada; McGill Interdisciplinary Initiative in Infection and Immunity, Montreal, Quebec, Canada.
Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Clin Microbiol Infect. 2023 Oct;29(10):1335.e1-1335.e7. doi: 10.1016/j.cmi.2023.06.013. Epub 2023 Jun 15.
We evaluated the field diagnostic accuracy of a syphilis rapid test (RDT), using serum and whole blood by non-laboratorians in two Canadian Arctic communities.
We implemented a multisite prospective field evaluation wherein patients were screened by an RDT containing treponemal and non-treponemal components (Chembio DPP® Syphilis Screen & Confirm) between January 2020 and December 2021. Venous whole blood and serum were collected for rapid testing and compared with laboratory-based serology reference testing using a reverse sequence algorithm of treponemal and rapid plasma reagin (RPR) testing.
Overall, 135 whole blood and 139 serum specimens were collected from 161 participants during clinical encounters. Treponemal-RDT sensitivity against a treponemal-reference standard (38/161 confirmed cases) was similar for serum (78% [95% CI: 61-90%]) and whole blood (81% [95% CI: 63-93%]). In those with RPR titres ≥1:8 (i.e. suggestive of recent/active infection), sensitivity increased to 93% (95% CI: 77-99%) for serum and 92% (95% CI: 73-99%) for whole blood. Treponemal-RDT specificity was excellent (99% [95% CI: 95-100%]) for both specimen types. Non-treponemal-RDT sensitivity against RPR was 94% (95% CI: 80-99%) for serum and 79% (95% CI: 60-92%) for whole blood. Sensitivity increased to 100% (95% CI: 88-100%) for serum and 92% (95% CI: 73-99%) for whole blood when RPR titres ≥1:8. RDT performance with whole blood was similar to that with serum.
Non-laboratorians using the RDT accurately identified individuals with infectious syphilis under real-world conditions in an intended-use setting at the point of care. Implementing the RDT can eliminate treatment delays and may enhance disease control.
我们评估了一种梅毒快速检测（RDT）在加拿大北极两个社区由非实验室人员使用血清和全血的现场诊断准确性。
我们实施了一项多站点前瞻性现场评估，在 2020 年 1 月至 2021 年 12 月期间，使用含有梅毒螺旋体和非梅毒螺旋体成分的 RDT（Chembio DPP®梅毒筛查和确认）对患者进行筛查。采集静脉全血和血清进行快速检测，并使用梅毒螺旋体和快速血浆反应素（RPR）检测的反向序列算法与实验室基于血清学的参考检测进行比较。
总体而言，在临床就诊期间，从 161 名参与者中采集了 135 份全血和 139 份血清标本。针对 161 例确诊病例（38 例）的梅毒螺旋体-RDT 对梅毒螺旋体参考标准的敏感性，血清（78% [95%置信区间：61-90%]）和全血（81% [95%置信区间：63-93%]）之间相似。在 RPR 滴度≥1:8 的患者中（即提示近期/活动性感染），血清的敏感性增加至 93%（95%置信区间：77-99%），全血的敏感性增加至 92%（95%置信区间：73-99%）。对于两种标本类型，梅毒螺旋体-RDT 的特异性均非常高（99% [95%置信区间：95-100%]）。非梅毒螺旋体-RDT 对 RPR 的敏感性，血清为 94%（95%置信区间：80-99%），全血为 79%（95%置信区间：60-92%）。当 RPR 滴度≥1:8 时，血清的敏感性增加至 100%（95%置信区间：88-100%），全血的敏感性增加至 92%（95%置信区间：73-99%）。全血的 RDT 性能与血清相似。
在实际使用环境中，非实验室人员在护理点使用 RDT 准确识别了具有传染性梅毒的个体。实施 RDT 可以消除治疗延误，并可能增强疾病控制。
