Access HBV Assays - European Union (EU) Clinical Trial Protocol -
- Conditions
- HBV
- Interventions
- Diagnostic Test: Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
- Registration Number
- NCT04904835
- Lead Sponsor
- Beckman Coulter, Inc.
- Brief Summary
The objective of this protocol is the collection and testing of clinical samples to determine the clinical performance of the Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer.
The study will involve a multicenter, prospective and retrospective collection of samples, and testing of samples with the investigational Hepatitis B Virus assays as required per the European Union Common Technical Specification. All samples collected will be anonymized or pseudo-anonymised, leftover, remnant samples. Pseudo-anonymised collection of samples will require documented patient consent (oral or written).
- Detailed Description
Sensitivity to final status on presumed HBV serological marker positive subjects will be calculated. Specificity will be calculated from hospitalized patients and blood donors specimens. False Initial Reactive Rate will be calculated on fresh hospitalized patient samples for Access HBsAg assay only (Qualitative).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 21210
-
Subject aged ≥ 18 years,
-
Subject who has provided consent (oral or written) or sample collected under waiver
-
With sufficient volume to perform clinical trial testing
-
And belonging to one of the following enrollment groups:
- Unselected blood donors
- Hospitalized patients
- Presumed HBsAg positive patients by Confirmatory testing of a CE-marked assay
- Patients having recovered from natural HBV infection, presumed Anti-HBs positive (i.e. Anti-HBs and Anti-HBc Total positive by CE-marked assays)
- Patients having received HBV vaccination, presumed Anti-HBs positive (confirmed by testing at the time of enrollment, i.e. positive for Anti-HBs and negative for Anti-HBc by CE-marked assays).
- Presumed Anti-HBc Total positive patients by a CE-marked assay
- Presumed Anti-HBc IgM positive patients by a CE-marked assay with acute/recent HBV infection 8
- Presumed HBeAg positive patients by a CE-marked assay
- Presumed Anti-HBe positive patients by a CE-marked assay
- Patients with chronic HBV infection
- Samples from subjects already included in the study* (* Patient can be included only once per HBV marker study, but can potentially be enrolled for several separate HBV marker studies.)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Presumed HBsAg positive patients Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays Leftover samples from patients at different stages of HBV infection (acute and chronic, minimum 10 per stage of infection), HBsAg positive by a Confirmatory testing of a CE-marked assay, including ≥ 25 "same day" fresh samples (tested ≤1 day after sampling), and minimum 20 high positive samples (\>26 IU/mL) and minimum 20 samples in the cut-off range. If not enough samples in the cut-off range are obtained during the clinical trial, additional HBsAg specimens in the cut-off range will be tested by Research \&Development to fit with Common Technical Specification requirements. Leftover samples to be tested by Access HBsAg assays and CE-marked predicate assays Patients having recovered from natural HBV infection, presumed Anti-HBs positive Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays Leftover samples from Patients positive for Anti-HBs and Anti-HBc Total by CE-marked assays. Target is to have at least ¾ of them recovered without HBV antiviral treatment. Leftover samples to be tested by Access anti-HBs assay and CE-marked predicate assays Presumed Anti-HBe positive patients7 Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays Leftover samples from Patients at different stages of infection (chronic and recovered, minimum 5 per stage of infection), positive for Anti-HBe by a CE-marked assay. Leftover samples to be tested by Access anti-HBe assay and CE-marked predicate assays Presumed Anti-HBc Total positive patients Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays Leftover samples from Patients at different stage of infection (acute, chronic or recovered, minimum 10 per stage of infection) positive for Anti-HBc Total by a CE-marked assay, including ≥ 25 "same day" fresh samples (tested ≤1 day after sampling). Leftover samples to be tested by Access anti-HBc Total and CE-marked predicate assays Presumed Anti-HBc IgM positive patients Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays left over samples from Patients with acute/recent HBV infection, positive for Anti-HBc IgM by a CE-marked assay. Leftover samples to be tested by Access anti-HBc IgM assay and CE-marked predicate assays Patients with chronic HBV infection Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays Leftover samples to be tested by Access anti-HBc IgM assay and CE-marked predicate assay Unselected blood donors Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays leftover samples from unselected blood donors from at least 2 donation centers. Leftover samples to be tested by Access HBV serological marker assays and CE-marked (european compliance marked) predicate assays Hospitalized patients Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays Leftover samples to be tested by Access HBV serological marker assays and CE-marked predicate assays Presumed HBeAg positive patients Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays Leftover samples from Patients at different stages of infection (acute and chronic, minimum 5 per stage of infection), positive for HBeAg by a CE-marked assay. Leftover samples to be tested by Access HBeAg assay and CE-marked predicate assays Patients having received HBV vaccination, presumed Anti-HBs positive Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays Leftover samples Confirmed as vaccinated by testing at the time of enrollment (i.e. positive for Anti-HBs and negative for Anti-HBc by CE-marked assays).Leftover samples to be tested by Access anti-HBs assay and CE-marked predicate assays
- Primary Outcome Measures
Name Time Method Diagnostic accuracy measured as sensitivity and specificity Baseline The endpoint will be diagnostic accuracy measured as sensitivity and specificity of Access HBV serological assays compared to sample status determined by specific testing algorithm for each HBV marker
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Etablissement Français du Sang (EFS) Hauts-de-France - Normandie
🇫🇷Bois Guillaume, France
Eurofins Biomnis
🇫🇷Ivry-sur-Seine, France
Laboratoire de Virologie, Laboratoire associé au CNR du VIH Institut de Biologie Clinique ; hôpital C : Nicolle, CHU Rouen
🇫🇷Rouen, France
Cerba Xpert
🇫🇷St Ouen l'Aumone, France
Centre de Ressources Biologiques Biobanque de Picardie CHU Amiens-Picardie
🇫🇷Amiens, France