NCT06368479Completed
Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings
A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings
Source: ClinicalTrials.gov · Last updated 21 Feb 2025
Brief summary (registry, in English)
A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of testing the samples on iStatis HBsAg Test at the point of care.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1400 (actual)
- First submitted
- 10 Apr 2024
- Start date
- 19 Mar 2024
- Primary completion date
- 19 Jul 2024
- Lead sponsor
- bioLytical Laboratories
- Diseases
- Hepatitis B
- NCT number
- NCT06368479
What you commit to
- Study type: Interventional
- Participants enrolled: 1400
- From 19 Mar 2024 to the primary completion date, 19 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Participant younger than 18 years old
Other
- Participants unable to provide written informed consent
Who the study is looking for
- Participants/subjects (males, females, and pregnant women) getting tested for Hepatitis B virus for one or more of the following reasons:
- at risk for Hepatitis B virus
- having signs and symptoms indicative for Hepatitis B virus
- Routine testing Unknown or other reasons will be captured
- Participants/subjects of 18 years or older and, who are able to give/sign the informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Epicentre Health Research Coordinator of this site? Confirm its status | Hillcrest | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.