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Abstract：
BACKGROUND: Southern African countries have the largest global burden of HIV and syphilis, with a high prevalence among women of reproductive age. Although antenatal screening is standard of care, syphilis screening has generally lagged behind HIV screening. We aimed to evaluate the performance and operational characteristics of two commercial dual HIV/syphilis point-of-care tests (POCTs) for simultaneous maternal HIV/syphilis screening.
METHODS: A clinic-based evaluation of dual HIV/syphilis POCTs (SD Bioline and Chembio) was conducted at five primary healthcare centres (PHCs) in South Africa and Zambia. POCT results using capillary fingerprick blood were compared to reference laboratory syphilis and HIV serological assays.
RESULTS: Three thousand four hundred twelve consenting pregnant women aged ≥ 18 years were enrolled. The prevalence of treponemal antibody seropositivity and HIV infection ranged from 3.7 to 9.9% (n = 253) and 17.8 to 21.3% (n = 643), respectively. Pooled sensitivity for syphilis compared to the reference assay was 66.0% (95%CI 57.7-73.4) with SD Bioline and 67.9% (95%CI 58.2-76.3) with Chembio. Pooled specificity for syphilis was above 98% with both POCTs. The sensitivities of SD Bioline and Chembio assays were 78.0% (95%CI 68.6-85.7) and 81.0% (95%CI 71.9-88.2), respectively compared to an active syphilis case definition of treponemal test positive with a rapid plasma reagin titre of ≥ 8. The negative predictive values (NPVs) based on various prevalence estimates for syphilis with both assays ranged from 97 to 99%. The pooled sensitivity for HIV was 92.1% (95%CI 89.4-94.2) with SD Bioline; and 91.5% (95%CI 88.2-93.9) with Chembio. The pooled specificities for HIV were 97.2% (95%CI 94.8-98.5) with SD Bioline and 96.7% (95%CI 95.1-97.8) with Chembio. The NPV based on various prevalence estimates for HIV with both assays was approximately 98%. Most participating women (91%) preferred dual POCTs over two single POCTs for HIV and syphilis, and healthcare providers gave favourable feedback on the utility of both assays at PHC level.
CONCLUSIONS: Based on the need to improve antenatal screening coverage for syphilis, dual HIV/syphilis POCTs could be effectively incorporated into antenatal testing algorithms to enhance efforts towards elimination of mother-to-child transmission of these infections.
METHODS: A clinic-based evaluation of dual HIV/syphilis POCTs (SD Bioline and Chembio) was conducted at five primary healthcare centres (PHCs) in South Africa and Zambia. POCT results using capillary fingerprick blood were compared to reference laboratory syphilis and HIV serological assays.
RESULTS: Three thousand four hundred twelve consenting pregnant women aged ≥ 18 years were enrolled. The prevalence of treponemal antibody seropositivity and HIV infection ranged from 3.7 to 9.9% (n = 253) and 17.8 to 21.3% (n = 643), respectively. Pooled sensitivity for syphilis compared to the reference assay was 66.0% (95%CI 57.7-73.4) with SD Bioline and 67.9% (95%CI 58.2-76.3) with Chembio. Pooled specificity for syphilis was above 98% with both POCTs. The sensitivities of SD Bioline and Chembio assays were 78.0% (95%CI 68.6-85.7) and 81.0% (95%CI 71.9-88.2), respectively compared to an active syphilis case definition of treponemal test positive with a rapid plasma reagin titre of ≥ 8. The negative predictive values (NPVs) based on various prevalence estimates for syphilis with both assays ranged from 97 to 99%. The pooled sensitivity for HIV was 92.1% (95%CI 89.4-94.2) with SD Bioline; and 91.5% (95%CI 88.2-93.9) with Chembio. The pooled specificities for HIV were 97.2% (95%CI 94.8-98.5) with SD Bioline and 96.7% (95%CI 95.1-97.8) with Chembio. The NPV based on various prevalence estimates for HIV with both assays was approximately 98%. Most participating women (91%) preferred dual POCTs over two single POCTs for HIV and syphilis, and healthcare providers gave favourable feedback on the utility of both assays at PHC level.
CONCLUSIONS: Based on the need to improve antenatal screening coverage for syphilis, dual HIV/syphilis POCTs could be effectively incorporated into antenatal testing algorithms to enhance efforts towards elimination of mother-to-child transmission of these infections.
摘要：
背景：南部非洲国家是全球艾滋病毒和梅毒负担最大的国家，在育龄妇女中患病率很高。虽然产前筛查是护理标准，梅毒筛查通常落后于HIV筛查。我们旨在评估两种商业化的双重HIV/梅毒护理点测试（POCT）的性能和操作特征，以同时进行母体HIV/梅毒筛查。
方法：在南非和赞比亚的五个初级保健中心（PHCs）对HIV/梅毒双重POCT（SDBioline和Chembio）进行了基于临床的评估。将使用毛细血管指刺血的POCT结果与参考实验室梅毒和HIV血清学测定进行比较。
结果：招募了三千四百十二名年龄≥18岁的孕妇。螺旋体抗体阳性和HIV感染的患病率为3.7％至9.9％（n=253）和17.8％至21.3％（n=643），分别。与参考测定相比，SDBioline对梅毒的合并敏感性为66.0％（95CI57.7-73.4），Chembio为67.9％（95CI58.2-76.3）。两种POCT对梅毒的集合特异性均高于98％。SDBioline和Chembio测定的灵敏度分别为78.0％（95CI68.6-85.7）和81.0％（95CI71.9-88.2），分别与活性梅毒病例定义的螺旋体试验阳性，血浆反应素快速滴度≥8进行比较。基于两种测定的梅毒的各种患病率估计的阴性预测值（NPV）范围为97％至99％。SDBioline对HIV的合并敏感性为92.1％（95CI89.4-94.2）；Chembio为91.5％（95CI88.2-93.9）。SDBioline的HIV合并特异性为97.2％（95CI94.8-98.5），Chembio的合并特异性为96.7％（95CI95.1-97.8）。基于两种测定的HIV的各种患病率估计的NPV约为98%。大多数参与的女性（91％）更喜欢双重POCT，而不是两个单独的POCT，以治疗艾滋病毒和梅毒。医疗保健提供者对两种检测方法在PHC水平的实用性给予了有利的反馈.
结论：基于提高梅毒产前筛查覆盖率的需要，可将双重HIV/梅毒POCT有效纳入产前检测算法,以加强努力消除这些感染的母婴传播.
方法：在南非和赞比亚的五个初级保健中心（PHCs）对HIV/梅毒双重POCT（SDBioline和Chembio）进行了基于临床的评估。将使用毛细血管指刺血的POCT结果与参考实验室梅毒和HIV血清学测定进行比较。
结果：招募了三千四百十二名年龄≥18岁的孕妇。螺旋体抗体阳性和HIV感染的患病率为3.7％至9.9％（n=253）和17.8％至21.3％（n=643），分别。与参考测定相比，SDBioline对梅毒的合并敏感性为66.0％（95CI57.7-73.4），Chembio为67.9％（95CI58.2-76.3）。两种POCT对梅毒的集合特异性均高于98％。SDBioline和Chembio测定的灵敏度分别为78.0％（95CI68.6-85.7）和81.0％（95CI71.9-88.2），分别与活性梅毒病例定义的螺旋体试验阳性，血浆反应素快速滴度≥8进行比较。基于两种测定的梅毒的各种患病率估计的阴性预测值（NPV）范围为97％至99％。SDBioline对HIV的合并敏感性为92.1％（95CI89.4-94.2）；Chembio为91.5％（95CI88.2-93.9）。SDBioline的HIV合并特异性为97.2％（95CI94.8-98.5），Chembio的合并特异性为96.7％（95CI95.1-97.8）。基于两种测定的HIV的各种患病率估计的NPV约为98%。大多数参与的女性（91％）更喜欢双重POCT，而不是两个单独的POCT，以治疗艾滋病毒和梅毒。医疗保健提供者对两种检测方法在PHC水平的实用性给予了有利的反馈.
结论：基于提高梅毒产前筛查覆盖率的需要，可将双重HIV/梅毒POCT有效纳入产前检测算法,以加强努力消除这些感染的母婴传播.
