Project title: “Architect HCVcore Ag Test Validation”.  Abbott Diagnostic, 01.05.2016 – 30.06.2017.

Project Summary

a). Project Objectives:

Evaluate new algorithm for screening and confirmation that will include Abbott Architect HCV core Ag test and use the Abbott Architect HCVcore Ag Test in the process of monitoring antiviral therapy in HCV positive patients.

b). Project implementation:  

NCDC team will perform testing of quality panel provided to evaluate performance characteristics such as diagnostic sensitivity and specificity, accuracy and limit of detection of tests.

The study will be conducted at Serology and Moleclar Epidemiology laboratories of NCDC – Lugar Center. NCDC will collect relevant samples for this study.

In the study will be collected 5000 samples from the HCV screening and the ‘’Blood Safety’’ programs and 1000 patients samples on Baseline, on-treatment week 4, end of treatment, and post treatment week 12 or 24 (On treatment week 12, 20 or 24 and depends on treatment mode ) selected randomly from STOP-C database.

All samples will be tested with  Abbott Architect anti-HCV, HIV Combo, HBV core (qualitative) and   anti-HBc positive will be tested by HBsAg; Rapid and standard ELISA test results will be compared.

Anti-HCV positive results by standard of care Rapid test, ELISA test  and Abbott Architect will be tested by Architect HCV core antigen. Architect Ab positive / Architect Ag negative results will be tested for confirmation by NAT testing Abbott RealTime HCV VL test.

Important final stage of the study: major endpoint for both studies: We will measure concordance of HCVcoreAg and HCV NAT results, and costs of different work flows, to determine feasibility and cost effectiveness of using HCVAg assay to confirm Current HCV Infection after screening, and to monitor treatment outcome, in comparison to the current standard of care testing.

c). Expected results:

All results will be compared to results from test of record and evaluated to determine whether or not Architect HCV core antigen assay can accurately discriminate patients who achieve a sustained virologic response from those who failed therapy.  This study will help to validate effectiveness of HCV core Ag test and to show costs of work flows  in low income country with high prevalence of hepatitis C.