Clinical trial NCT04139941: Evaluation Study of HCV RDTs in Fresh Samples
Official title: Prospective Diagnostic Accuracy Study of Rapid Diagnostic Tests (RDTs) Detecting Antibodies Against Hepatitis C Virus (HCV) in Freshly Collected Whole Blood, Plasma and Serum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus Infection
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: Institute of Tropical Medicine, Belgium
First posted: 2019-10-25
Enrollment: 1540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * General population
* HCV high-risk individuals

Brief summary: This study evaluates the sensitivity and specificity performance of three Hepatitis C Virus (HCV) rapid diagnostic tests (RDTs) in freshly collected fingerstick whole blood, as well as serum and plasma (Premier Medical Corporation First Response HCV RDT; Beijing Wantai HCV RDT; AccessBio Care Start HCV under development). Performance is compared to the SD Bioline HCV RDT, as well as a composite reference standard, consisting of two enzyme Immunoassay and a line immunoassay.

Detailed description: Hepatitis C virus (HCV) infection is a major public health burden, with an estimated 71 million patients being infected globally. If undiagnosed, HCV infection can lead to severe liver damage, including hepatocellular carcinoma (HCC). The World Health Organization (WHO) recently set a target to eliminate HCV by 2030. The first critical step in reaching this target is to accurately identify people infected with HCV. Globally, significant gaps remain in diagnosis of HCV, with four out of five people infected still unaware of their status, largely due to lack of access to testing services.

In resource-limited settings (RLS), laboratory-based testing remains a mainstay for HCV screening and confirmatory testing. Such laboratory-based assays rely on transportation of temperature-sensitive samples from clinic sites to centralized laboratories, high-tech equipment and highly skilled laboratory technicians, limiting the scope of access to testing and resulting in long turn-around times for results. In recent years, new technologies have been developed to decentralize HCV screening and confirmatory testing using point-of-care (POC) assays to overcome these barriers and improve patient outcomes.

Rapid diagnostic tests (RDT) for screening for HCV are affordable, accurate, easy to use by healthcare workers, and robust in field settings. Although a number of HCV RDTs are on the market, currently only two have received WHO pre-qualification (PQ) status, demonstrating their accuracy and reliability for use in the field in RLS. Data on a number of other RDTs indicate their suitability for use. More data is needed, however, in field settings for these HCV RDTs, to demonstrate their accuracy and quality in end-user studies and to provide evidence for WHO PQ approval.

Based on the results of a recent FIND laboratory evaluation assessing the performance of 13 HCV RDTs using archived plasma samples, we have selected three candidate HCV RDTs ("study RDTs") for further evaluation in field settings (e.g. primary healthcare facilities). The performance of these RDTs measured in frozen plasma specimens indicated that they have a high potential to meet WHO PQ performance criteria in freshly collected samples. In addition, the manufacturers each demonstrate evidence of engagement to pursue both CE-mark status and the WHO PQ process, showing commitment to delivering quality-assured tests to the market.

The data generated during this study will be used to inform national and international stakeholders on HCV RDT performance in field settings and shared with manufacturers to support the evidence package for WHO PQ and/or CE-marking.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Known or unknown HCV serology
* No history of past or present HCV treatment
* Willing to undergo the information and consenting procedure and subsequently have enough time to participate in the study
* Willing to provide 13 ml venepuncture blood sample and a minimum of four whole blood fingerstick samples
* Willing to perform an HIV test
* Individuals can already be registered at the local site or register for the first time when enrolling in the study

Exclusion Criteria:

* Participants not able to consent themselves (incapable)

Primary outcomes:
measure: Sensitivity and specificity of HCV RDTs compared to a composite reference standard
timeFrame: through study completion, on average 1 year
Secondary outcomes:
measure: Sensitivity and specificity of HCV RDTs compared to an HCV RDT pre-qualified by WHO as reference standard
timeFrame: through study completion, on average 1 year
measure: Operational characteristics
timeFrame: through study completion, on average 1 year
measure: Operational characteristics
timeFrame: through study completion, on average 1 year
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: Sihanouk Hospital Centre of Hope
city: Tbilisi
country: Georgia
facility: National Center for Disease Control & Public Health/Lugar Center
Study officials:
References: