Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623071
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Accupower HBV Performance Evaluation Quant Kit Bioneer Existation FA 96384
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Accupower HBV Performance Evaluation Quant Kit Bioneer ExistationFA 96384
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOPERF-HBV
Brief Summary:
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 2017746
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
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
Detailed Description:
Viral hepatitis are primarily human systemic infections caused by viruses hepatic diseases which cause damage to the liver by hepatocyte infection of the virus andor a host immune response to the virus 1 Hepatitis is grouped into five types A B C D E and is mainly transmitted by parenteral sexual and fetomaternal 2 Hepatitis B virus HBV was discovered in 1965 in the United States3It is a DNA virus that belongs to the family Hepadnaviridae 4 Hepatitis B infection is characterized by signs clinical conditions such as jaundice asthenia anorexia but in the vast majority of cases 98 of infections The course of hepatitis B is not serious Nine out of ten people will clear the virus thanks to their immune defenses they heal spontaneously and are immune because they made antibodies against HBV5 In 10 of infected people 15 in men 5 in women the hepatitis virus B will remain in the liver where it will be more or less active This activity leads to chronic hepatitis
Approximately 316 million people are chronic carriers of HBV worldwide 1-3 and approximately 887000 deaths are linked to the hepatitis B virus each year Appropriate support for carrying Chronic HBV reduces the risk of transmission The WHO has set the goal of elimination of viral hepatitis B and C in 20305 The biomarkers specifically associated with this infection are Hbs antigen HbsAg antibodies anti-Hbs anti-HBc antibodies Hbe antigen anti-HBe antibodies virus DNA in plasma
Chronic hepatitis B is defined by the maintenance of HBs antigen in the blood beyond 6 months6 The diagnosis of acute hepatitis B is based on the combination of a clinical picture such as acute febrile state
accompanied or followed by jaundice or an increase in hepatic transaminases AST ALT gammaGT and the presence of HBs antigen and anti-HBc IgM and viral DNA in the blood6 Treatment monitoring of chronic hepatitis B is carried out by monitoring the viral load of hepatitis B in the blood Furthermore quantification of viral load during hepatitis monitoring Chronic B is essential in order to be able to assess and anticipate the risk of progression towards fibrosis6 On the European market quantitative determination of hepatitis B viral load as part of Diagnosis and monitoring of the disease is done by real-time PCR which is the reference technique7 As part of routine care there are several diagnostic PCR kits that can be used on plasma or serum Today there are no CE approved PCR kits that allow the quantification of viral DNA at the both serum and plasma Our study will make it possible to evaluate the performance of the Bioneer kit PCR kit AccuPower Quant Kit Bioneer ExiStationFA 96384 on serum and plasma from patients with hepatitis B
Approximately 316 million people are chronic carriers of HBV worldwide 1-3 and approximately 887000 deaths are linked to the hepatitis B virus each year Appropriate support for carrying Chronic HBV reduces the risk of transmission The WHO has set the goal of elimination of viral hepatitis B and C in 20305 The biomarkers specifically associated with this infection are Hbs antigen HbsAg antibodies anti-Hbs anti-HBc antibodies Hbe antigen anti-HBe antibodies virus DNA in plasma
Chronic hepatitis B is defined by the maintenance of HBs antigen in the blood beyond 6 months6 The diagnosis of acute hepatitis B is based on the combination of a clinical picture such as acute febrile state
accompanied or followed by jaundice or an increase in hepatic transaminases AST ALT gammaGT and the presence of HBs antigen and anti-HBc IgM and viral DNA in the blood6 Treatment monitoring of chronic hepatitis B is carried out by monitoring the viral load of hepatitis B in the blood Furthermore quantification of viral load during hepatitis monitoring Chronic B is essential in order to be able to assess and anticipate the risk of progression towards fibrosis6 On the European market quantitative determination of hepatitis B viral load as part of Diagnosis and monitoring of the disease is done by real-time PCR which is the reference technique7 As part of routine care there are several diagnostic PCR kits that can be used on plasma or serum Today there are no CE approved PCR kits that allow the quantification of viral DNA at the both serum and plasma Our study will make it possible to evaluate the performance of the Bioneer kit PCR kit AccuPower Quant Kit Bioneer ExiStationFA 96384 on serum and plasma from patients with hepatitis B
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None