CompletedNot Applicable

Retrospective Study of iStatis Syphilis Ab Test (POC)

South Africa1,500 participantsStarted 2023-11-15

Plain-language 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.

Who can participate

Age range15 Years

SexALL

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Inclusion criteria

✓. Anti-Tp negative samples:
✓Stored at ≤ -80°C.
✓. Anti-Tp negative samples - pregnant women:
✓. Anti-Tp positive samples:
✓. Anti-Tp positive samples - pregnant women:

What they're measuring

Sensitivity and specificity of the iStatis Syphilis Ab Test

Timeframe: 8 weeks

Trial details

NCT IDNCT06367621

SponsorbioLytical Laboratories

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-04-15

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