Evaluation Study of HCV RDTs in Fresh Samples
Evaluation Study of HCV RDTs in Fresh Samples
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.
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.
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)