Hepatitis C Clinical Trial
Official title:
Evaluation Study of Rapid Diagnostic Tests (RDTs) Detecting Antibodies Against Hepatitis C Virus
NCT number | NCT04033887 |
Other study ID # | 8162-2/1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 21, 2018 |
Est. completion date | March 15, 2019 |
Verified date | July 2019 |
Source | Foundation for Innovative New Diagnostics, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1710 |
Est. completion date | March 15, 2019 |
Est. primary completion date | March 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria of archived samples: - 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 Exclusion Criteria: - Samples not stored correctly |
Country | Name | City | State |
---|---|---|---|
Belgium | Institute of Tropical Medicine | Antwerp | |
Georgia | National Center for Disease Control & Public Health/Lugar Center | Tbilisi | |
Nigeria | Nigerian Institute of Medical Research | Lagos |
Lead Sponsor | Collaborator |
---|---|
Foundation for Innovative New Diagnostics, Switzerland | Institute of Tropical Medicine, Belgium, Nigerian Institute of Medical Research, Richard Lugar Centre for Public Health Research, Georgia |
Belgium, Georgia, Nigeria,
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. — View Citation
Reipold, E.I., Evaluation of the diagnostic performance of the Xpert® Fingerstick HCV Viral Load (VL) Assay. Manuscript in preparation 2019
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Point estimates of sensitivity and specificity, with 95% confidence intervals, of RDTs for the detection of anti-HCV antibodies in the overall sample population. | 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, HCV-ve/HIV-ve, HCV+ve/ HIV+ve and HCV-ve/HIV+ve; the was performed for all RDT manufacturers and individually for each lot. The estimates were calculated on the overall sample population. | 6 months | |
Secondary | Operational characteristics | Inter-reader variability: Fleiss Kappa Coefficient (?) of inter-reader variability per RDT; manufacturer lot Lot-to-lot variability: coefficient of lot-to-lot variability (percentage agreement) per RDT manufacturer Rate of invalid runs: Percent of invalid runs per manufacturer lot | 6 months | |
Secondary | Technical appraisal rating on kit instructions, packaging, labelling and test conduct, on a Likert scale | Averages of likert-scale scores will be calculated and serve to understand the user-friendliness of the RDT; there is no expected outcome, the scale rating is used to collect consistent feedback from users; scale scores are as follows: 1=poor, 2=needs improvement, 3=satisfactory, 4=good, 5=excellent | 6 months |
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