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

> **NCT06365606** · NA · COMPLETED · sponsor: **bioLytical Laboratories** · enrollment: 1500 (actual)

## Conditions studied

- Syphilis Infection
- Syphilis

## Interventions

- **DEVICE:** iStatis Syphilis Ab Test

## Key facts

- **NCT ID:** NCT06365606
- **Lead sponsor:** bioLytical Laboratories
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2024-03-14
- **Primary completion:** 2024-05-13
- **Final completion:** 2024-07-11
- **Target enrollment:** 1500 (ACTUAL)
- **Last updated:** 2024-08-12


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06365606

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06365606, "Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT06365606. Licensed CC0.

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