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Retrospective Study of iStatis Syphilis Ab Test (POC)

NCT06367621 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2024-08-12

No results posted yet for this study

Summary

The purpose of this retrospective clinical trial is to establish the clinical performance of the iStatis Syphilis AbTest. The data will be used to demonstrate the product is safe and effective for its intended use. The data obtained will be used in the application for CE certification under In Vitro Diagnostic Medical Device Regulation (IVDR) and World Health Organization (WHO) prequalification.

Conditions

  • Syphilis
  • Syphilis Infection

Interventions

DEVICE

iStatis Syphilis Antibody Test

1500 stored samples (plasma/serum) will be tested in a routine testing environment using the iStatis Syphilis Antibody Test diagnostic device. Results of tests will not be used for patient management decisions (observaltional).

Sponsors & Collaborators

  • bioLytical Laboratories

    lead INDUSTRY

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2024-04-15
Completion
2024-07-11

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06367621 on ClinicalTrials.gov