CompletedNot Applicable

Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites

South Africa1,500 participantsStarted 2024-03-14

Plain-language summary

This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and plasma (i.e., obtained through venous EDTA whole blood collection and processing) are collected by a healthcare professional. The collected samples are tested in a routine testing environment, i.e., healthcare providers at

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants/subjects (males, females, and pregnant women) getting tested for syphilis for one or more of the following reasons: o at risk for syphilis ohaving signs and symptoms indicative for syphilis oRoutine testing * Participants/subjects of 18 years or older and, who are able to give/sign the informed consent. Exclusion Criteria: * Participant younger than 18 years old * Participants unable to provide written informed consent * Participants currently undergoing treatment

What they're measuring

Sensitivity and specificity of the iStatis Syphilis Ab Test

Timeframe: 15 weeks

Trial details

NCT IDNCT06365606

SponsorbioLytical Laboratories

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-13

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