Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04971330
Study type Observational
Source Beckman Coulter, Inc.
Contact
Status Completed
Phase
Start date November 4, 2019
Completion date March 30, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05942937 - National Prisons Hepatitis Education Project: Research Evaluation N/A
Completed NCT02604017 - A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection Phase 3
Completed NCT01221298 - A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV) Phase 2
Recruiting NCT05794646 - Community Intervention to Eliminate HCV Among People Who Use Drugs. N/A
Completed NCT02247401 - Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt Phase 3
Completed NCT02833298 - Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening N/A
Active, not recruiting NCT03981445 - Integrated HIV Prevention and HCV Care for PWID N/A
Completed NCT02452814 - Long Term Extension Study is Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Subjects With Chronic Hepatitis C Virus Genotype 1 Infection N/A
Recruiting NCT05904470 - A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV Phase 2
Not yet recruiting NCT06316739 - The Ganchero Intervention for Migrant People Who Inject Drugs From Puerto Rico in New York City N/A
Completed NCT02116543 - TD-6450 MAD Study in HCV Infected Subjects Phase 1
Recruiting NCT05454579 - The South-East Asian Transgender Health Cohort
Active, not recruiting NCT03221309 - Hepatitis C Treatment to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior
Completed NCT03801707 - Utilization of Hepatitis C Positive Kidneys in Negative Recipients Phase 2/Phase 3
Not yet recruiting NCT03820102 - Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With HCV Infection Treated by DAAs
Completed NCT01074008 - A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072 Phase 2
Completed NCT05616598 - Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters Phase 2/Phase 3
Recruiting NCT05854511 - Pharmacokinetics, Safety, Efficacy and Acceptability of Daclatasvir Plus Sofosbuvir in HCV-infected Children Phase 3
Completed NCT03069001 - Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV Phase 4
Completed NCT01842451 - A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C Phase 2