NCT06368466Completed
A Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites
A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites
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 the study. Capillary (fingerstick) whole blood and EDTA venipuncture whole blood are collected by a healthcare professional. The collected samples of capillary and EDTA whole blood are tested on iStatis and EDTA whole blood sample will be processed to obtain serum and plasma samples to be tested on the iStatis. An aliquot of the collected serum sample will be shipped to the central laboratory for confirmatory testing. The results from iStatis HBsAg Test results will not be used for patient management decisions.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 175 (actual)
- First submitted
- 10 Apr 2024
- Start date
- 30 Apr 2024
- Primary completion date
- 5 Jul 2024
- Lead sponsor
- bioLytical Laboratories
- Diseases
- Hepatitis B
- NCT number
- NCT06368466
What you commit to
- Study type: Interventional
- Participants enrolled: 175
- From 30 Apr 2024 to the primary completion date, 5 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
- Patient younger than 18 years old
Other
- Patients unable to provide written informed consent.
- Patients currently undergoing treatment
Who the study is looking for
- Patients/subjects (males, females, and pregnant women) getting tested for HBV for one or more of the following reasons:
- at risk for HBV
- having signs and symptoms indicative of HBV
- pregnant and have HBV.
- Re-infected with HBV (previously positive)
- Patients/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 |
|---|---|---|---|
| St Vincent's Hospital Melbourne Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.