Clinical trial NCT06623058: Accupower ® HCV Performance Evaluation Quant Kit Bioneer Existation™FA 96/384
Official title: Accupower ® HCV Performance Evaluation Quant Kit Bioneer Existation™FA 96/384
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HEPATITIS C (HCV)
Lead sponsor: CerbaXpert
Sponsor class: OTHER
Collaborators: name: Bioneer Corporation
First posted: 2024-10-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infected patients with hepatitis C virus

Brief summary: As part of the CE marking of a hepatitis C 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 suffering from the virus hepatitis C and whose viral load is positive. This prospective collection will be carried out in 4 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 and/or 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) The hepatitis C virus (HCV) was discovered in 1989.(3) It is an RNA virus that belongs to the family Flaviviridae.(4) Infection with the hepatitis C virus is characterized by clinical signs such as such as jaundice, asthenia, anorexia. In approximately 30% (15% to 45%) of infected people, the virus is spontaneously eliminated within six months following infection, without any treatment. (5) For the remaining 70% (55% to 85%), the infection will progress to a chronic form. In patients chronic, the risk of cirrhosis is 15% to 30% in the 20 years following infection. (5) A assessment of liver damage and virus replication in the blood is made before starting treatment.(6) Detection/quantification of HCV RNA in serum or plasma must therefore be available before to initiate antiviral treatment. HCV RNA must be tested for by a sensitive test giving a result viral load expressed in IU/ml and Log IU/ml. (6) Monitoring of response to treatments is done also by the detection of viral RNA, particularly at 12 weeks post-treatment where a viral load undetectable is a sign of effective treatment and healing. (6) On the European market, quantitative determination of hepatitis C viral load as part of Diagnosis and monitoring of the disease is done by real-time PCR which is the reference technique.(7) 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 RNA at the both serum and plasma. Our study will make it possible to evaluate the performance of the Bionner kit PCR kit ACCUPOWER Quant Kit Bioneer Existation™FA 96/384 on serum and plasma of affected patients hepatitis C.

Eligibility criteria: Inclusion Criteria:

The patient to be included in this study must be able to understand the purpose of the research, in order to to give free and informed consent.

* Subject aged over 18
* Subject presenting at the investigation center and meeting one of these two criteria:

  * Subject presenting with a prescription for HCV viral load determination
  * Subject whose HCV infection is previously confirmed by CE marked tests.
* Subject capable of understanding the purpose of the research having given express free and informed consent
* Subject affiliated to or beneficiary of a social security system

Exclusion Criteria:

Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative Subject participating in a clinical study/receiving investigational treatment

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Primary outcomes:
measure: Commutability between serum and plasma hepatitis C viral load results with the ACCUPOWER HCV Quant Kit Bioneer Existation™FA 96/384.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Frepillon
country: France
facility: Cerba Xpert
state: Ile de France
Study officials:
References: