Access HBV Assays - European Union (EU) Clinical Trial Protocol -
NCT ID: NCT04904835
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
21210 participants
OBSERVATIONAL
2019-10-15
2026-05-31
Brief Summary
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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
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Unselected blood donors
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
Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
All samples will be tested with both CE-marked HBV serological predicate assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) and Access HBV serological assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) according to respective Instructions For Use to determine non-reactive (NR), initially reactive (IR), repeatedly reactive (RR), or confirmed or not confirmed Positive.
Hospitalized patients
Leftover samples to be tested by Access HBV serological marker assays and CE-marked predicate assays
Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
All samples will be tested with both CE-marked HBV serological predicate assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) and Access HBV serological assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) according to respective Instructions For Use to determine non-reactive (NR), initially reactive (IR), repeatedly reactive (RR), or confirmed or not confirmed Positive.
Presumed HBsAg positive patients
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
Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
All samples will be tested with both CE-marked HBV serological predicate assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) and Access HBV serological assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) according to respective Instructions For Use to determine non-reactive (NR), initially reactive (IR), repeatedly reactive (RR), or confirmed or not confirmed Positive.
Patients having recovered from natural HBV infection, presumed Anti-HBs positive
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
Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
All samples will be tested with both CE-marked HBV serological predicate assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) and Access HBV serological assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) according to respective Instructions For Use to determine non-reactive (NR), initially reactive (IR), repeatedly reactive (RR), or confirmed or not confirmed Positive.
Patients having received HBV vaccination, presumed Anti-HBs positive
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
Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
All samples will be tested with both CE-marked HBV serological predicate assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) and Access HBV serological assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) according to respective Instructions For Use to determine non-reactive (NR), initially reactive (IR), repeatedly reactive (RR), or confirmed or not confirmed Positive.
Presumed Anti-HBc Total positive patients
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
Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
All samples will be tested with both CE-marked HBV serological predicate assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) and Access HBV serological assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) according to respective Instructions For Use to determine non-reactive (NR), initially reactive (IR), repeatedly reactive (RR), or confirmed or not confirmed Positive.
Presumed Anti-HBc IgM positive patients
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
Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
All samples will be tested with both CE-marked HBV serological predicate assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) and Access HBV serological assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) according to respective Instructions For Use to determine non-reactive (NR), initially reactive (IR), repeatedly reactive (RR), or confirmed or not confirmed Positive.
Presumed HBeAg positive patients
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
Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
All samples will be tested with both CE-marked HBV serological predicate assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) and Access HBV serological assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) according to respective Instructions For Use to determine non-reactive (NR), initially reactive (IR), repeatedly reactive (RR), or confirmed or not confirmed Positive.
Presumed Anti-HBe positive patients7
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
Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
All samples will be tested with both CE-marked HBV serological predicate assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) and Access HBV serological assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) according to respective Instructions For Use to determine non-reactive (NR), initially reactive (IR), repeatedly reactive (RR), or confirmed or not confirmed Positive.
Patients with chronic HBV infection
Leftover samples to be tested by Access anti-HBc IgM assay and CE-marked predicate assay
Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
All samples will be tested with both CE-marked HBV serological predicate assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) and Access HBV serological assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) according to respective Instructions For Use to determine non-reactive (NR), initially reactive (IR), repeatedly reactive (RR), or confirmed or not confirmed Positive.
Interventions
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Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
All samples will be tested with both CE-marked HBV serological predicate assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) and Access HBV serological assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) according to respective Instructions For Use to determine non-reactive (NR), initially reactive (IR), repeatedly reactive (RR), or confirmed or not confirmed Positive.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Beckman Coulter, Inc.
INDUSTRY
Responsible Party
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Locations
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Centre de Ressources Biologiques Biobanque de Picardie CHU Amiens-Picardie
Amiens, , France
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
Saint-Ouen-l'Aumône, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Dzamitika S, Boulaire FL, Coignard C, Vincent C, Plantier JC, Lemee V, Greaume S, Voisin I, Brochot E, Herpe YE, Demirdjian G, Karagueuzian M, Afful D, Bayoud R, Hey J. Performance evaluation of the Access anti-HBc Total assay on the DxI 9000 Access Immunoassay Analyzer. Diagn Microbiol Infect Dis. 2024 Sep;110(1):116303. doi: 10.1016/j.diagmicrobio.2024.116303. Epub 2024 Apr 20.
Other Identifiers
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HBV-EU-08-19
Identifier Type: OTHER
Identifier Source: secondary_id
DC-TR18-0408
Identifier Type: -
Identifier Source: org_study_id