Division of Infectious Diseases, University of Toronto, Toronto, Canada.
Sex Transm Infect. 2010 Jun;86(3):193-8. doi: 10.1136/sti.2009.038778. Epub 2009 Dec 3.
We undertook a prospective evaluation of the Qualpro Syphicheck-WB rapid syphilis test to measure its diagnostic performance and utility as a point-of-care (POC) screening test among female sex workers (FSWs) in Bangalore, India.
From August 2008 to May 2009, FSWs without a laboratory-confirmed history of syphilis attending STI clinics in Bangalore underwent POC syphilis screening using finger-prick whole blood, with onsite treatment if indicated. Serum samples were collected for local laboratory offsite rapid plasma reagin (RPR) testing and reference laboratory RPR, Treponema pallidum haemagglutination assay (TPHA), and rapid syphilis testing. FSWs who participated in standard offsite RPR screening from August 2007 to May 2008 in the same clinics formed the comparison group for treatment coverage.
Of the 1617 women who underwent POC syphilis testing, 7.4% had laboratory evidence of active syphilis with reactive RPR and TPHA, and 3.7% had an RPR titre > or = 1:8. Compared with the reference RPR and TPHA, the sensitivity and specificity of the POC syphilis test were 70.8% (95% CI 62.7 to 79.0) and 97.8% (95% CI 97.1 to 98.5). Because of the low rate of women returning for their test results after offsite RPR screening, the proportion of women with active syphilis who were appropriately treated rose from 44.8% to 68.3% with the use of POC syphilis screening (p=0.003).
The Syphicheck-WB test utilising finger-prick whole blood has a relatively low sensitivity in detecting active syphilis. However, among hard-to-reach populations who may not return for follow-up treatment, POC screening with this assay could still confer an advantage over offsite RPR testing with respect to treatment coverage.
我们前瞻性评估了 Qualpro Syphicheck-WB 快速梅毒检测,以衡量其在印度班加罗尔的女性性工作者(FSW)中作为即时护理(POC)筛查试验的诊断性能和实用性。
2008 年 8 月至 2009 年 5 月,无实验室确诊梅毒史的 FSW 在班加罗尔的性传播感染诊所接受了基于手指刺破全血的 POC 梅毒筛查,如果需要则进行现场治疗。采集血清样本进行本地实验室场外快速血浆反应素(RPR)检测和参考实验室 RPR、梅毒螺旋体血凝试验(TPHA)和快速梅毒检测。2007 年 8 月至 2009 年 5 月期间在同一诊所参加标准场外 RPR 筛查的 FSW 形成了治疗覆盖率的对照组。
在接受 POC 梅毒检测的 1617 名女性中,7.4%的实验室证据显示活动性梅毒,RPR 和 TPHA 呈阳性,3.7%的 RPR 滴度>或=1:8。与参考 RPR 和 TPHA 相比,POC 梅毒检测的敏感性和特异性分别为 70.8%(95%CI 62.7%至 79.0%)和 97.8%(95%CI 97.1%至 98.5%)。由于场外 RPR 筛查后返回检测结果的女性比例较低,因此使用 POC 梅毒筛查可将患有活动性梅毒的女性的适当治疗比例从 44.8%提高到 68.3%(p=0.003)。
利用手指刺破全血的 Syphicheck-WB 试验在检测活动性梅毒方面的敏感性相对较低。然而,在可能不会返回接受后续治疗的难以接触的人群中,与场外 RPR 检测相比,使用该检测进行 POC 筛查仍可能在治疗覆盖方面具有优势。