Evaluation of a hepatitis B diagnostic kit
Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation™FA 96/384
This study is testing a new hepatitis B diagnostic kit to see if it accurately identifies infections in patients with the virus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CerbaXpert Academic / other |
| Locations | 2 sites (Frépillon, Ile de Franace and 1 other locations) |
| Trial ID | NCT06623071 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the performance of a hepatitis B diagnostic kit developed by Bioneer as part of its CE marking process. The study involves the prospective collection of blood samples from patients with a positive HBV viral load across three laboratories within the Cerba Healthcare group in France. By analyzing these samples, the study seeks to ensure the diagnostic kit meets regulatory standards and effectively identifies hepatitis B infections.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have a confirmed HBV infection or a prescription for HBV viral load determination.
Not a fit: Patients who are under legal protection or participating in another clinical study may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and reliability of hepatitis B diagnostics, leading to better patient management and outcomes.
How similar studies have performed: Other studies evaluating diagnostic kits for hepatitis B have shown success, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The patient to be included in this study must be able to understand the purpose research, in order to give free and informed consent. * Subject aged over 18 * Subject presenting himself at the investigation center and responding to one of these two criteria: * Subject presenting with a prescription for determination HBV viral load * Subject with previously confirmed HBV infection by CE marked tests. * Subject capable of understanding the aim of the research having given express free and informed consent * Subject affiliated to or beneficiary of a social security system Exclusion Criteria: Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative • Subject participating in another clinical study
Where this trial is running
Frépillon, Ile de Franace and 1 other locations
- Cerba Xpert — Frépillon, Ile de Franace, France (Not_yet_recruiting)
- Cerballiance Chemin vert — France, Paris, France (Recruiting)
Study contacts
- Study coordinator: Sabrina KALI, Dr.
- Email: kali.rinasab@gmail.com
- Phone: 33762376831
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.