Abstract：
OBJECTIVE: 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.
CONCLUSIONS: 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.
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.
CONCLUSIONS: 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：梅毒的单次访视检测和治疗可以减少随访。这项研究的目的是评估两种梅毒/HIV双重护理点测试（POCT）的性能和治疗结果。
方法：使用两个极快（<5分钟）设备[MedMiraMultiploRapidTP/HIV测试和INSTIMultiplexHIV1/2梅毒Ab测试]，向16岁及以上的参与者提供来自手指刺血的并发梅毒/HIVPOCT。POCT结果阳性的人在同一天接受梅毒治疗，并与艾滋病毒护理挂钩。护士在两个急诊科进行了检测，第一民族社区，惩教设施和性传播感染诊所。将POCT结果与标准血清学测试进行比较。计算敏感性和特异性。
结果：在2020年8月至2022年2月之间，完成了1526次访问。两个POCT都准确地识别了HIV参与者(敏感度=100·0%[24/24]，95%CI=86·2-100·0%，特异性=99·6%[1319/1324]，95%CI=99·1-99·8%)，将24例艾滋病毒病例与护理联系起来。两种测试在RPR>8稀释度时最敏感(倍数:灵敏度=98·3%[231/235]，95%CI=95·7-99·3%，特异性=99·5%[871/875]，95%CI=98·8-99·8%，INSTI多路复用：灵敏度=97·9%[230/235]，95%CI=95·1-99·1%，特异性=99·8%[873/875]，95％CI=99·2-99·9％），对非反应性RPR的敏感性最低（乘数：敏感性=54·1％[59/109]，95%CI=44·8-63·2%，特异性=99·5%[871/875]，95%CI=98·8-99·8%，INSTI多路复用：灵敏度=28·4%[31/109]，95%CI=20·8-37·5%，特异性=99·8%[873/875]，95%CI=99·2-99·9%)。POCT阳性的87·0%在同一天治疗。
结论：两种极其快速（<5分钟）的双重梅毒/HIVPOCT对活动性梅毒（RPR>1：8稀释）和HIV的诊断显示出极好的敏感性和特异性，并证实了在不同临床环境中提供梅毒的单次访问测试和治疗以及与HIV护理的联系的能力。
方法：使用两个极快（<5分钟）设备[MedMiraMultiploRapidTP/HIV测试和INSTIMultiplexHIV1/2梅毒Ab测试]，向16岁及以上的参与者提供来自手指刺血的并发梅毒/HIVPOCT。POCT结果阳性的人在同一天接受梅毒治疗，并与艾滋病毒护理挂钩。护士在两个急诊科进行了检测，第一民族社区，惩教设施和性传播感染诊所。将POCT结果与标准血清学测试进行比较。计算敏感性和特异性。
结果：在2020年8月至2022年2月之间，完成了1526次访问。两个POCT都准确地识别了HIV参与者(敏感度=100·0%[24/24]，95%CI=86·2-100·0%，特异性=99·6%[1319/1324]，95%CI=99·1-99·8%)，将24例艾滋病毒病例与护理联系起来。两种测试在RPR>8稀释度时最敏感(倍数:灵敏度=98·3%[231/235]，95%CI=95·7-99·3%，特异性=99·5%[871/875]，95%CI=98·8-99·8%，INSTI多路复用：灵敏度=97·9%[230/235]，95%CI=95·1-99·1%，特异性=99·8%[873/875]，95％CI=99·2-99·9％），对非反应性RPR的敏感性最低（乘数：敏感性=54·1％[59/109]，95%CI=44·8-63·2%，特异性=99·5%[871/875]，95%CI=98·8-99·8%，INSTI多路复用：灵敏度=28·4%[31/109]，95%CI=20·8-37·5%，特异性=99·8%[873/875]，95%CI=99·2-99·9%)。POCT阳性的87·0%在同一天治疗。
结论：两种极其快速（<5分钟）的双重梅毒/HIVPOCT对活动性梅毒（RPR>1：8稀释）和HIV的诊断显示出极好的敏感性和特异性，并证实了在不同临床环境中提供梅毒的单次访问测试和治疗以及与HIV护理的联系的能力。
