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| Name | Class |
|---|---|
| MagIA Diagnostics | INDUSTRY |
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The principal objective of the study is to perform a first step of technical adjustment and preliminary validation of a diagnostic test for hepatitis B (HBsAntigen, anti-HBs Antibody and anti-HBc Antibody) on capillary blood with the device under study in non-immunized subjects against hepatitis B, in subjects with hepatitis B, in subjects with old or cured hepatitis B and in hepatitis B vaccine recipients, compared with the values obtained with the reference technique of medical biology laboratory on serum. The analysis will be performed on the entire cohort.
The diagnosis of hepatitis B in precarious populations is often difficult. The use of a in vitro diagnosis-medical device in point of care could alleviate this difficulty. It would identify whether or not the subjects are infected with the virus, whether they are immunized or not. Then, depending on the results, the subjects could be directly vaccinated or referred to a laboratory of medical biology for confirmation / invalidation of the diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-immunized Hepatitis B | Experimental | subjects non-immunized against hepatitis B (naive) |
|
| Vaccine Hepatitis B | Experimental | subjects vaccinated against hepatitis B |
|
| Ongoing, Old or cured Hepatitis B | Experimental | subjects with hepatitis B (old or cured) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Demonstrator MAGIA | Diagnostic Test | test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject. |
|
| Measure | Description | Time Frame |
|---|---|---|
| feasibility of correlation | To evaluate the feasibility estimated by correlation of the measurements (HBsAg, anti-HBs Ab, HBc-Ab) between the IVD-MD in point of care on capillary blood study and the laboratory results obtained on serum | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| repeatability of the measurement HBsAg, anti-HBs Ab, HBc-Ab | Comparison of the repeatability of the measurement of HBsAg, anti-HBs Ab, HBc-Ab on 2 different fingers with the same device and the same batch of consumables with 2 different times | day 0 |
| reproductibility of the measurement HBsAg, anti-HBs Ab, HBc-Ab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc CRACOWSKI, MD, PhD | Grenoble Alps University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical research center CIC1406 | Grenoble | 38000 | France |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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3 parallel groups of 10 volunteers
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Comparison of the reproducibility of HBsAg, anti-HBs Ab, HBc-Ab via a test from 2 drops of blood on 2 different fingers with 2 different cartridges and two different readers |
| day 0 |
| correlation according to status | Comparison of the correlation coefficients of the measurements between the IVD-MD in point of care and the biology automaton according to the different statuses | day 0 |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |