# Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings

> **NCT06368479** · NA · COMPLETED · sponsor: **bioLytical Laboratories** · enrollment: 1400 (actual)

## Conditions studied

- Hepatitis B
- Hepatitis B Infection

## Interventions

- **DEVICE:** iStatis HBsAg Test

## Key facts

- **NCT ID:** NCT06368479
- **Lead sponsor:** bioLytical Laboratories
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2024-03-19
- **Primary completion:** 2024-07-19
- **Final completion:** 2024-07-19
- **Target enrollment:** 1400 (ACTUAL)
- **Last updated:** 2025-02-21


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06368479

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06368479, "Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT06368479. Licensed CC0.

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