An observational study in HBV, sponsored by Beckman Coulter, Inc.. Completed at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Beckman Coulter, Inc. (part of Danaher Corporation) · Observational
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).
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).
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's enrollment of 21,210 is above the median of 365 across 251 observational studies indexed under Hepatitis B.
Browse Hepatitis B studies →Beckman Coulter, Inc. is the lead sponsor of 31 studies on the registry; 1 is open to participants now.
First submitted after Beckman Coulter, Inc. became part of Danaher Corporation.
Counted across the registry records on this site, refreshed daily.
The test population includes :
9- 220 Presumed Anti-HBe positive patients 10- 100 Patients with chronic HBV infection TOTAL n=21,210
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
And belonging to one of the following enrollment groups:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Diagnostic Test: 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
Diagnostic Test: 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
Diagnostic Test: 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
Diagnostic Test: 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
Diagnostic Test: 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
Diagnostic Test: 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
Diagnostic Test: 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
Diagnostic Test: 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
Diagnostic Test: 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
Diagnostic Test: 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.
Diagnostic accuracy measured as sensitivity and specificity
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
Time frame: Baseline
Plan to share: No
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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