Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384
ConditionHepatitis B
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCerbaXpert
About this trial
As part of the CE marking of a hepatitis B diagnostic kit, the South Korean manufacturer Bioneer wishes to set up a performance study in France in accordance with the IVDR (RE 2017/746).
Cerba Xpert CRO of the Cerba Healthcare group promoted this performance study by setting up a prospective collection of blood samples from patients with hepatitis B virus and whose viral load is positive. This prospective collection will be carried out in 3 laboratories of the Cerba Healthcare group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject aged over 18
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
Disqualifiers
None
Trial population
Infected patients with hepatitis B virus
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
45 Participants
are grouped into 1 trial groupGroup A: Infected patients
Trial outcomes
Primary outcomes
1
Commutability between serum and plasma hepatitis B viral load results with the ACCUPOWER HBV Quant Kit Bioneer Existation™FA 96/384
The submitted protocol is carried out as part of a 'commutability' study, that is to say for Compare two matrix types on the Accupower ® HBV Quant Kit Bioneer Existence™FA 96/384. Indeed, for these two matrices to be claimed in the IFU of the kit it is necessary to prove that the two matrices give the same result. The planned size of the evaluable cohort is 45 patients included over a period of 4 month. This size is justified by the recommendations of the applicable CLSI EP09 guide. This guide details the use of several mathematical models that guarantee robust analysis even on a small cohort size. The operating methodology of the results is detailed below, taken from the recommendations of the CLSI EP09 guide
Time frame
4 monthsSponsors and contacts
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CerbaXpert
Lead sponsor
Bioneer Corporation
Collaborator
Source ClinicalTrials.gov