Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.

IF 5.4 2区 医学 Q1 MICROBIOLOGY
Journal of Clinical Microbiology Pub Date : 2025-09-10 Epub Date: 2025-08-05 DOI:10.1128/jcm.00244-25
Kevin Clark, Antony George Joyee, Diane Biddison, Sharon Rabine, Jianghong Qian, Sydney Spradlin, Vicki Thompson, Qinwei Shi, Jing Xu, Lu Zhang, Alicia Brown, Lisa Nibauer, Raji Pillai, Jody D Berry
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引用次数: 0

Abstract

The resurgence of syphilis in the USA and globally has hastened the need for widely available syphilis testing. Early detection of syphilis is crucial for avoiding serious clinical complications and preventing the spread of infection. Self-tests enhance access to testing and promote timely treatment for positive cases. Herein, we describe the performance of First to Know Syphilis Test (FTK), the first over-the-counter (OTC) treponemal test. A prospective multi-site clinical study with 1,270 subjects was conducted, where subjects self-collected fingerstick capillary blood and self-tested without assistance. FTK test results were compared with a composite reference standard to evaluate the diagnostic performance. The FTK test exhibited an overall sensitivity of 93.4% (95% CI, 87.0% to 96.8%) and specificity of 99.5% (95% CI, 98.9% to 99.8%) and accuracy of 99%. The overall agreement was 98.9%, with Cohen's Kappa (ⱪ) value 0.93 (95% CI, 0.90 to 0.97) showing excellent agreement between the reference standard and FTK results. In addition, the test was validated in a panel of 125 clinically staged syphilis patient samples, and the results showed 100% agreement in detecting anti-treponemal antibodies in all the samples. These data show excellent performance of the FTK Test, demonstrating its utility in the screening and diagnosis of syphilis. The availability of this OTC test and its excellent performance will have a profound impact on syphilis detection and prevention strategies and could reduce comorbidities such as HIV and transmission of other STIs.

Importance: The resurgence of syphilis in the USA and globally underscores the urgent need for rapid, accessible testing. The First To Know Syphilis Test, as the first at-home, over-the-counter (OTC) test for syphilis, represents a significant breakthrough in rapid diagnostics for increased access to testing and support early diagnosis and treatment. The FTK test demonstrated excellent overall clinical performance, with 93.4% sensitivity and 99.5% specificity, confirming its reliability for syphilis detection. This novel, easy-to-use OTC syphilis test allows individuals to privately test at home and can promote testing among those hesitant or unable to seek traditional healthcare, reducing barriers like stigma and limited access. The availability of this OTC test will have a significant impact on syphilis detection and prevention strategies and reduction of comorbidities such as HIV.

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Abstract Image

首先知道梅毒自检的临床发展和性能,用于非处方使用:从头开始快速检测梅毒螺旋体抗体。
梅毒在美国和全球的死灰复燃加速了广泛提供梅毒检测的需要。早期发现梅毒对于避免严重的临床并发症和防止感染的传播至关重要。自我检测可提高获得检测的机会,并促进对阳性病例的及时治疗。在这里,我们描述的性能首先知道梅毒测试(FTK),第一个非处方(OTC)梅毒螺旋体测试。本研究对1270名受试者进行了一项前瞻性的多地点临床研究,受试者在没有帮助的情况下自行采集指尖毛细血管血并进行自我检测。将FTK检测结果与综合参考标准进行比较,评价诊断性能。FTK试验的总灵敏度为93.4% (95% CI, 87.0% ~ 96.8%),特异性为99.5% (95% CI, 98.9% ~ 99.8%),准确性为99%。总体一致性为98.9%,Cohen’s Kappa(ⱪ)值0.93 (95% CI, 0.90 ~ 0.97)表明参考标准与FTK结果非常吻合。此外,该测试在125个临床分期梅毒患者样本中进行了验证,结果显示在所有样本中检测抗梅毒螺旋体抗体的一致性为100%。这些数据显示了FTK测试的优异性能,证明了其在梅毒筛查和诊断中的实用性。这种OTC检测方法的可用性及其优异的性能将对梅毒检测和预防策略产生深远的影响,并可减少艾滋病毒等合并症和其他性传播感染的传播。重要性:梅毒在美国和全球的死灰复燃凸显了对快速、可获得的检测的迫切需要。首先了解梅毒检测作为首个家庭非处方梅毒检测,代表了快速诊断方面的重大突破,增加了检测的可及性,并支持早期诊断和治疗。FTK试验临床综合表现优异,灵敏度为93.4%,特异度为99.5%,证实了其检测梅毒的可靠性。这种新颖、易于使用的非处方梅毒检测方法允许个人在家中私下进行检测,并可以促进那些犹豫不决或无法寻求传统医疗保健的人进行检测,从而减少污名化和获取途径有限等障碍。这种非处方药检测的可用性将对梅毒检测和预防策略以及减少艾滋病毒等合并症产生重大影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Clinical Microbiology
Journal of Clinical Microbiology 医学-微生物学
CiteScore
17.10
自引率
4.30%
发文量
347
审稿时长
3 months
期刊介绍: The Journal of Clinical Microbiology® disseminates the latest research concerning the laboratory diagnosis of human and animal infections, along with the laboratory's role in epidemiology and the management of infectious diseases.
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