Evaluation Study of RDTs Detecting Antibodies Against HCV

NCT04033887 | Completed

• 1 other identifier: 8162-2/1
• Study Type: observational
• Target: 1,710
• Locations: 3 countries
• Sites: 3

Brief Summary

The study aims to evaluate 13 different HCV RDTs (10 on-market, 3 under development) for their diagnostic performance and operational characteristics in archived EDTA plasma samples, originating from patients from different geographical regions (Nigeria, Georgia, Cambodia, Belgium) and with or without HIV co-infection.

Conditions

Hepatitis C

Keywords

Diagnosis; HIV coinfection; Rapid diagnostic test

Outcome Measures

Primary Outcomes (2)

• Point estimates of sensitivity and specificity, with 95% confidence intervals, of RDTs for the detection of anti-HCV antibodies in individuals not co-infected with HIV.

  Point estimates of sensitivity and specificity, with 95% confidence Intervals based on Wilson's score method, will be computed for all samples HCV+ve/HIV-ve and HCV-ve/HIV-ve; the calculation was performed for all RDT manufacturers and individually for each lot. The estimates were calculated on the overall sample population.

  6 months

• Point estimates of sensitivity and specificity, with 95% confidence intervals, of RDTs for the detection of anti-HCV antibodies in HIV co-infected individuals.

  Point estimates of sensitivity and specificity, with 95% confidence Intervals based on Wilson's score method, were computed for all samples HCV+ve/HIV+ve and HCV-ve/HIV+ve; the calculation was performed for all RDT manufacturers and individually for each lot. The estimates were calculated on the overall sample population.

  6 months

Secondary Outcomes (3)

• Point estimates of sensitivity and specificity, with 95% confidence intervals, of RDTs for the detection of anti-HCV antibodies in the overall sample population.

  6 months

• Operational characteristics

  6 months

• Technical appraisal rating on kit instructions, packaging, labelling and test conduct, on a Likert scale

  6 months

Study Arms (2)

HCV-only infected

Archived frozen plasma samples from individuals that were characterised to be HCV-antibody positive or HCV-antibody negative ("HCV-only infected"). These samples are characterised for their HIV status (negative).

Diagnostic Test: 13 Rapid Diagnostic Tests and reference tests

HCV/HIV co-infected

Archived frozen plasma samples from HCV-positive or HCV-negative individuals who are HIV infected ("HCV/HIV co-infected").

Diagnostic Test: 13 Rapid Diagnostic Tests and reference tests

Interventions

13 Rapid Diagnostic Tests and reference tests DIAGNOSTIC_TEST

Rapid diagnostic tests: 1. HCV antibody test (under development); bioLytical Laboratories 2. DPP® HCV (under development); Chembio Diagnostic Systems 3. HCV-Ab Rapid Test; Beijing Wantai Biological Pharmacy Enterprise 4. Rapid Anti-HCV Test; InTec 5. First Response HCV Card Test; Premire Medical Corporation 6. Signal HCV Ver 3.0; Arkray healthcare 7. TRI DOT HCV; J. Mitra \& Co 8. Triplex HIV, HCV, HBsAg; Biosynex SA 9. Standard Q HCV Ab; SD Biosensor 10. HCV Hepatitis Virus Antibody Test; Artron Laboratories 11. SD Bioline HCV; Abbott Diagnostics 12. OraQuick HCV; OraSure 13. Care Start HCV Rapid Test (under development); Access Bio Reference tests: Enzyme Immunoassays (EIAs): Murex Anti-HCV EIA version 4.0; Fujirebio Innotest HCV Ab IV Line Immunoassay (LIA): MP Diagnostics HCV blot 3.0

HCV-only infected; HCV/HIV co-infected

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Samples tested in Belgium originate from Cambodia (80%) and Belgium (20%). Cambodian samples are leftovers from samples collected during a cross-sectional study of hepatitis C among people living with HIV (De Weggheleire, A. 2017); samples in Belgium were collected and archived during routine patient care visits to the HIV clinic. Samples in Nigeria originate from routine diagnostic activities at NIMR as well as the AIDS Prevention Initiative Nigeria (APIN) PEPFAR Program Sample/Data Bank setup at NIMR and the Lagos University Teaching Hospital. Samples tested in Georgia are leftover samples from a previous FIND HCV study (Reipold, E.I., 2019), as well as archived routine diagnostic samples from the site. Percent sample distribution per site: Belgium: 38% Nigeria: 41% Georgia: 21%

You may qualify if:

• Non-hemolytic plasma samples with EDTA used as anticoagulant
• Sample were frozen at -20°C or lower on the day of processing and stored at -20°C or lower until they are used in this study
• Samples pre-characterized for, HCV, HIV serology status using assays routinely used at the sites and approved for diagnostic use by a local health authority. If available, samples should also be characterized for HBV status.
• Samples taken from subjects aged ≥18 years
• Availability of informed consent to use the sample in future research

You may not qualify if:

• \- Samples not stored correctly

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• Institute of Tropical Medicine, Belgium: collaborator
• Nigerian Institute of Medical Research: collaborator
• Richard Lugar Centre for Public Health Research, Georgia: collaborator

Study Sites (3)

Institute of Tropical Medicine

Antwerp, 2000, Belgium

Location

National Center for Disease Control & Public Health/Lugar Center

Tbilisi, 0198, Georgia

Location

Nigerian Institute of Medical Research

Lagos, Nigeria

Location

Related Publications (3)

• De Weggheleire A, An S, De Baetselier I, Soeung P, Keath H, So V, Ros S, Teav S, Smekens B, Buyze J, Florence E, van Griensven J, Thai S, Francque S, Lynen L. A cross-sectional study of hepatitis C among people living with HIV in Cambodia: Prevalence, risk factors, and potential for targeted screening. PLoS One. 2017 Aug 23;12(8):e0183530. doi: 10.1371/journal.pone.0183530. eCollection 2017.

  PMID: 28832660 BACKGROUND

• Reipold, E.I., Evaluation of the diagnostic performance of the Xpert® Fingerstick HCV Viral Load (VL) Assay. Manuscript in preparation 2019

  BACKGROUND

• Vetter BN, Reipold EI, Ongarello S, Audu R, Ige FA, Alkhazashvili M, Chitadze N, Vanroye F, De Weggheleire A, An S, Fransen K. Sensitivity and Specificity of Rapid Diagnostic Tests for Hepatitis C Virus With or Without HIV Coinfection: A Multicentre Laboratory Evaluation Study. J Infect Dis. 2022 Aug 26;226(3):420-430. doi: 10.1093/infdis/jiaa389.

  PMID: 32614451 DERIVED

MeSH Terms

Conditions

Hepatitis C; Disease; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Ranga Sampath, PhD

  Foundation for Innovative New Diagnostics, Geneva, Switzerland

  STUDY DIRECTOR

• Rosemary Audu, PhD

  Nigerian Institute of Medical Research, Lagos, Nigeria

  PRINCIPAL INVESTIGATOR

• Katrien Fransen, PhD

  Institute of Tropical Medicine, Antwerp, Belgium

  PRINCIPAL INVESTIGATOR

• Maia Alkhazashvili, Masters

  NCDC Lugar Centre, Tbilisi, Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: July 26, 2019
• Study Start: September 21, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); GE (1); NG (1)