Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Access Anti-HCV Assay European Union (EU) Clinical Trial Protocol (HCV-EU-10-18)

12 juillet 2021 mis à jour par: Beckman Coulter, Inc.

Evaluation of the Beckman Coulter Access Anti-HCV Assay as an Aid in the Diagnosis of HCV Infection: EU Clinical Trial Protocol

The objective of this study was the collection and testing of clinical samples to determine the clinical performance in terms of diagnostic accuracy measured by specificity and sensitivity of the Access anti-Hepatitis C Virus (anti-HCV) assay on the DxI 9000 Access Immunoassay Analyzer. The Design Input Document (DID) indicates performance requirements and minimum target enrollment numbers (based on those in the CTS) of blood donor, hospitalized patient and known HCV antibody (Ab) positive samples for novel anti-HCV assays. A secondary objective was to determine the false initial reactive rate (IRR) of the Access anti-HCV assay.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

The study involved a multicenter, prospective and retrospective collection of samples, and testing of samples with the investigational Access anti-HCV assay. Subject sample enrollment was targeted to be approximately 8,000 specimens including approximately 6,000 blood donors and 1,500 hospitalized individuals for the specificity populations and 500 confirmed HCV Ab positive patients for the sensitivity population, required by European Union's Common Technical Specification for clinical validation of in vitro diagnostic medical devices and marketing needs to align with competitor submissions. Retrospective collection included HCV Ab positive genotyped samples from existing vendor collections meeting all inclusion/exclusion criteria.

All samples collected were anonymized, leftover, remnant samples and therefore member state or Institutional Review Board/Independent Ethics Committee approval was not required. Diagnostic sensitivity and specificity were evaluated for sample antibody status determined by a CE-marked anti-HCV assay (Abbott ARCHITECT anti-HCV assay for hospitalized patient and positive samples or Abbott PRISM HCV assay for blood donor samples) and Immunoblot testing with FUJIREBIO INNO-LIA HCV Score, if necessary. HCV RNA Polymerase Chain Reaction (PCR) or genotyping was requested or was available on all Immunoblot positive samples for further characterization, but these results were not used to determine final antibody status.

A portion of hospitalized patient samples (target 700/1500) and the majority of positive HCV Ab samples were collected and stored frozen prior to testing. A targeted portion of 800 hospitalized patient samples, 30 known positive samples and all blood donor samples were collected and tested fresh. Fresh blood donor and fresh hospitalized patient samples were used to determine false Initial Reactive Rate (IRR).

Type d'étude

Observationnel

Inscription (Réel)

7901

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • France
      • Bois-Guillaume, France, 76232
        • Etablissement Français du Sang (EFS) Hauts-de-France - Normandie
      • Ivry-sur-Seine, France, 94208
        • Eurofins Biomnis
      • Saint-Ouen-l'Aumône, France, 95310
        • Cerba Xpert

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

N/A

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The test population includes :

  • 513 Known HCV Ab Positive Patients
  • 1533 Hospitalized patients
  • 5855 Unselected Blood donors

La description

Inclusion Criteria:

Anonymized or pseudo-anonymised leftover ethylenediaminetetraacetic acid (EDTA) plasma/serum samples from

  • Males or females
  • Aged ≥18 years of age

  • Belonging to one of the following enrollment groups

    • Unselected blood donor
    • Hospitalized patient from GI, hepatology, Internal Medicine or Infectious Disease services
    • Known HCV Ab positive (by Immunoblot) at different stages of disease
  • with at least 1.5 mL leftover sample (without genotype or PCR on same draw) OR
  • at least 0.8 mL leftover sample (with genotype or HCV PCR on same draw)

Exclusion Criteria:

  • Samples from subjects already included in the study

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Known HCV Ab Positive Patients
leftover samples be tested with both reference anti-HCV assay and Access anti-HCV assay according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. Reference assay will be Abbott Architect anti-HCV assay for positive samples.
Test diagnostique: Access HCV

All samples were tested with both reference anti-HCV assay and Access anti-HCV assay according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. Reference assay was Abbott Architect anti-HCV assay. For blood donors, Abbott PRISM HCV was used as reference.

For the specificity cohorts (blood donor and hospitalized patient samples), all HCV Ab positive results will have supplemental confirmation testing with HCV Immunoblot for final HCV Ab status
Hospitalized Patients

leftover samples be tested with both reference anti-HCV assay and Access anti-HCV assay according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. Reference assay will be Abbott Architect anti-HCV assay for hospitalized patient.

For the specificity cohorts (blood donor and hospitalized patient samples), all HCV Ab positive results will have supplemental confirmation testing with HCV Immunoblot for final HCV Ab status
Test diagnostique: Access HCV

All samples were tested with both reference anti-HCV assay and Access anti-HCV assay according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. Reference assay was Abbott Architect anti-HCV assay. For blood donors, Abbott PRISM HCV was used as reference.

For the specificity cohorts (blood donor and hospitalized patient samples), all HCV Ab positive results will have supplemental confirmation testing with HCV Immunoblot for final HCV Ab status
Unselected Blood Donors

Leftover samples be tested with both reference anti-HCV assay and Access anti-HCV assay according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. les. For blood donors, Abbott PRISM HCV will be used as reference.

For the specificity cohorts (blood donor and hospitalized patient samples), all HCV Ab positive results will have supplemental confirmation testing with HCV Immunoblot for final HCV Ab status.
Test diagnostique: Access HCV

All samples were tested with both reference anti-HCV assay and Access anti-HCV assay according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. Reference assay was Abbott Architect anti-HCV assay. For blood donors, Abbott PRISM HCV was used as reference.

For the specificity cohorts (blood donor and hospitalized patient samples), all HCV Ab positive results will have supplemental confirmation testing with HCV Immunoblot for final HCV Ab status

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
sensitivity and specificity
Délai: Baseline
sensitivity and specificity relative to the final patient HCV Ab status determined from reference HCV Ab assay and/or supplemental confirmation testing (HCV Ab result by immunoblot).
Baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Beckman Coulter, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 novembre 2019

Achèvement primaire (Réel)

30 mars 2021

Achèvement de l'étude (Réel)

30 mars 2021

Dates d'inscription aux études

Première soumission

12 juillet 2021

Première soumission répondant aux critères de contrôle qualité

12 juillet 2021

Première publication (Réel)

21 juillet 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 juillet 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 juillet 2021

Dernière vérification

1 juillet 2021

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • DC-TR18-0406

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Access HCV

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Ethiopia

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

3
S'abonner