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加拿大用于诊断和治疗传染性梅毒的两种即时检测点（PoSH 研究）梅毒和 HIV 的敏感性和特异性：一项横断面研究。

Sensitivity and specificity of two investigational Point of care tests for Syphilis and HIV (PoSH Study) for the diagnosis and treatment of infectious syphilis in Canada: a cross-sectional study.

机构信息

Department of Medicine, University of Alberta, Edmonton, Alberta, Canada; Edmonton STI Clinic, Edmonton, Alberta, Canada.

Edmonton STI Clinic, Edmonton, Alberta, Canada.

出版信息

Clin Microbiol Infect. 2023 Jul;29(7):940.e1-940.e7. doi: 10.1016/j.cmi.2023.02.015. Epub 2023 Mar 2.

DOI:10.1016/j.cmi.2023.02.015

PMID:36868357

Abstract

OBJECTIVES

Single-visit testing and treatment for syphilis can reduce follow-up visits. The objectives of this study were to evaluate the performance and treatment outcomes of two dual syphilis/HIV point-of-care tests (POCTs).

METHODS

Participants aged 16 years and older were offered concurrent syphilis/HIV POCTs with fingerstick blood sampling using two extremely rapid (<5 minutes) devices (MedMira Multiplo Rapid TP/HIV test and INSTI Multiplex HIV-1/HIV-2/Syphilis Antibody Test). Those with positive POCT results were offered same-day syphilis treatment and linkage to HIV care. Nurses performed testing at two emergency departments, a First Nations community, a correctional facility, and a sexually transmitted infection clinic. POCT results were compared with those of standard serological testing. Sensitivity and specificity were calculated.

RESULTS

Between August 2020 and February 2022, 1526 visits were completed. Both POCTs accurately identified participants with HIV (sensitivity, 100% [24 of 24]; 95% CI, 86.2-100%; specificity, 99.6% [1319 of 1324]; 95% CI, 99.1-99.8%), linking 24 HIV cases to care. Both tests were most sensitive with a rapid plasma reagin (RPR) of ≥1:8 dilutions (Multiplo: sensitivity, 98.3% [231 of 235]; 95% CI, 95.7-99.3%; specificity, 99.5% [871 of 875]; 95% CI, 98.8-99.8%; INSTI Multiplex: sensitivity, 97.9% [230 of 235]; 95% CI, 95.1-99.1%; specificity, 99.8% [873 of 875]; 95% CI, 99.2-99.9%) and least sensitive with non-reactive RPR (Multiplo: sensitivity, 54.1% [59 of 109]; 95% CI, 44.8-63.2%; specificity, 99.5% [871 of 875]; 95% CI, 98.8-99.8%; INSTI Multiplex: sensitivity, 28.4% [31 of 109]; 95% CI, 20.8-37.5%; specificity, 99.8% [873 of 875]; 95% CI, 99.2-99.9%). Eighty-five percent of participants with infectious syphilis were treated on the same day as the positive POCT result.

DISCUSSION

Two extremely rapid (<5 minutes) dual syphilis/HIV POCTs showed excellent sensitivity and specificity for the diagnosis of active syphilis (RPR, ≥1:8 dilutions) and HIV and confirmed the ability to offer single-visit testing and treatment for syphilis and linkage to HIV care in diverse clinical settings.

摘要

目的

梅毒的单次就诊检测和治疗可减少随访次数。本研究旨在评估两种梅毒/艾滋病毒即时检测（POCT）的性能和治疗结果。

方法

年龄在 16 岁及以上的参与者接受了使用两种极快速（<5 分钟）设备（MedMira Multiplo Rapid TP/HIV 检测和 INSTI Multiplex HIV-1/HIV-2/梅毒抗体检测）进行的同时梅毒/艾滋病毒 POCT 检测，采用指端血样。POCT 结果阳性的患者接受了当天的梅毒治疗和艾滋病毒护理。护士在两家急诊科、一个第一民族社区、一个惩教设施和一个性传播感染诊所进行了检测。将 POCT 结果与标准血清学检测结果进行比较。计算了敏感性和特异性。

结果

2020 年 8 月至 2022 年 2 月期间，完成了 1526 次就诊。两种 POCT 均能准确识别艾滋病毒感染者（敏感性，100%[24/24]；95%置信区间，86.2-100%；特异性，99.6%[1319/1324]；95%置信区间，99.1-99.8%），并将 24 例艾滋病毒病例转介至护理。两种检测在快速血浆反应素（RPR）≥1:8 稀释度时最敏感（Multiplo：敏感性，98.3%[231/235]；95%置信区间，95.7-99.3%；特异性，99.5%[871/875]；95%置信区间，98.8-99.8%；INSTI Multiplex：敏感性，97.9%[230/235]；95%置信区间，95.1-99.1%；特异性，99.8%[873/875]；95%置信区间，99.2-99.9%），而非反应性 RPR 时最不敏感（Multiplo：敏感性，54.1%[59/109]；95%置信区间，44.8-63.2%；特异性，99.5%[871/875]；95%置信区间，98.8-99.8%；INSTI Multiplex：敏感性，28.4%[31/109]；95%置信区间，20.8-37.5%；特异性，99.8%[873/875]；95%置信区间，99.2-99.9%）。阳性 POCT 结果当天，85%的感染性梅毒患者接受了治疗。