PDF(Pubmed)
Abstract：
BACKGROUND: There have been few empirical studies for diagnostic test accuracy of syphilis using a sequence of rapid tests in populations with low prevalence of syphilis such as pregnant women. This analysis describes syphilis test positivity frequency among pregnant women at an antenatal clinic in Zambia using a reverse-sequence testing algorithm for antenatal syphilis screening.
METHODS: Between August 2019 and May 2023, we recruited 1510 pregnant women from a peri-urban hospital in Lusaka, Zambia. HIV positive and HIV negative women were enrolled in a 1:1 ratio. Blood collected at recruitment from the pregnant mothers was tested on-site for syphilis using a rapid treponemal test. Samples that tested positive were further tested at a different laboratory, with rapid plasma reagin using archived plasma.
RESULTS: Of the total 1,421 sera samples which were screened with a rapid treponemal test, 127 (8.9%) were positive and 1,294 (91.1%) were negative. Sufficient additional samples were available to perform RPR testing on 114 of the 127 (89.8%) RDT positive specimens. Thirty-one (27.2%) of these 114 were reactive by RPR and 83 (72.8%) were negative, resulting in a syphilis overtreatment rate of 3 fold (i.e, 84/114). Insufficient sample or test kit availability prevented any testing for the remaining 89 (5.9%) participants.
CONCLUSIONS: Use of only treponemal tests in low prevalence populations, like pregnant women, subjects individuals with non-active syphilis to the costs and possible risks of overtreatment. The use of the dual treponemal and non-treponemal tests would minimize this risk at some additional cost.
METHODS: Between August 2019 and May 2023, we recruited 1510 pregnant women from a peri-urban hospital in Lusaka, Zambia. HIV positive and HIV negative women were enrolled in a 1:1 ratio. Blood collected at recruitment from the pregnant mothers was tested on-site for syphilis using a rapid treponemal test. Samples that tested positive were further tested at a different laboratory, with rapid plasma reagin using archived plasma.
RESULTS: Of the total 1,421 sera samples which were screened with a rapid treponemal test, 127 (8.9%) were positive and 1,294 (91.1%) were negative. Sufficient additional samples were available to perform RPR testing on 114 of the 127 (89.8%) RDT positive specimens. Thirty-one (27.2%) of these 114 were reactive by RPR and 83 (72.8%) were negative, resulting in a syphilis overtreatment rate of 3 fold (i.e, 84/114). Insufficient sample or test kit availability prevented any testing for the remaining 89 (5.9%) participants.
CONCLUSIONS: Use of only treponemal tests in low prevalence populations, like pregnant women, subjects individuals with non-active syphilis to the costs and possible risks of overtreatment. The use of the dual treponemal and non-treponemal tests would minimize this risk at some additional cost.
摘要：
背景：在梅毒患病率较低的人群（如孕妇）中，使用一系列快速测试来进行梅毒诊断测试准确性的实证研究很少。该分析使用反向序列测试算法进行产前梅毒筛查，描述了赞比亚产前诊所孕妇的梅毒测试阳性频率。
方法：在2019年8月至2023年5月之间，我们从卢萨卡的郊区医院招募了1510名孕妇，赞比亚。HIV阳性和HIV阴性妇女以1：1的比例登记。从孕妇招募时收集的血液使用快速密螺旋体测试进行了梅毒现场测试。测试阳性的样品在不同的实验室进一步测试，使用存档的血浆进行快速血浆反应。
结果：在用快速螺旋体试验筛选的1,421份血清样本中，127（8.9％）为阳性，1,294（91.1％）为阴性。足够的额外样品可用于对127个(89.8%)RDT阳性样品中的114个进行RPR测试。这114人中有31人（27.2％）被RPR反应，83人（72.8％）为阴性，导致梅毒过度治疗率为3倍（i。e,84/114)。样本或检测试剂盒的可用性不足阻止了其余89名（5.9％）参与者的任何测试。
结论：在低患病率人群中仅使用密螺旋体检测，像孕妇一样，对患有非活动性梅毒的个体进行过度治疗的成本和可能的风险。双重螺旋体和非螺旋体测试的使用将以一些额外的成本最小化这种风险。
方法：在2019年8月至2023年5月之间，我们从卢萨卡的郊区医院招募了1510名孕妇，赞比亚。HIV阳性和HIV阴性妇女以1：1的比例登记。从孕妇招募时收集的血液使用快速密螺旋体测试进行了梅毒现场测试。测试阳性的样品在不同的实验室进一步测试，使用存档的血浆进行快速血浆反应。
结果：在用快速螺旋体试验筛选的1,421份血清样本中，127（8.9％）为阳性，1,294（91.1％）为阴性。足够的额外样品可用于对127个(89.8%)RDT阳性样品中的114个进行RPR测试。这114人中有31人（27.2％）被RPR反应，83人（72.8％）为阴性，导致梅毒过度治疗率为3倍（i。e,84/114)。样本或检测试剂盒的可用性不足阻止了其余89名（5.9％）参与者的任何测试。
结论：在低患病率人群中仅使用密螺旋体检测，像孕妇一样，对患有非活动性梅毒的个体进行过度治疗的成本和可能的风险。双重螺旋体和非螺旋体测试的使用将以一些额外的成本最小化这种风险。
