Diagnostic Performance of SD Bioline, Accurate, Fortress and Encode Compared to the Mindray CLIA 1200i Test in Volunteer Blood Donors at Kinshasa University Hospital

Abstract

Background and Purpose: The hepatitis C prevalence rate is among the highest the world. Thus, in the context of transfusion safety, WHO has made it compulsory to screen blood bags by rapid diagnostic orientation tests (TROD) validated in regions that do not have the capacity to use more sophisticated technologies. The purpose of this study is to assess the performance of the TRODs commonly used in Kinshasa. Methods: This was a cross-sectional and analytical study carried out from August 26, 2019 to January 20, 2020 in 200 voluntary blood donors at the University Clinics of Kinshasa (CUK). The detection of anti-HCV antibodies was carried out by Mindray (gold standard) and the SD Bioline, Encode, Fortress and Accurate tests. The diagnostic performance of TRODs was evaluated compared to the Mindray test. Results: Of a total of 200 donors, 112 (56.0%) were male versus 88 (44.0%) female with a sex ratio of 1M: 1F. HCV seroprevalences by Mindray, and other tests were 29.5%, 28.0%, 27.0%, 27.0% and 31.5%, respectively; the Se, Sp, VPP, VPN, SD Bioline, Accurate, Fortress and Encode were 74.6%, 92.9%, 81.5%, 89.7%, respectively; 74.6%, 92.9%, 81.5%, 89.7%; 74.6%, 91.4%, 78.6%, 89.6%; 69.5%, 70.0%, 65.1%, 84.4%. Conclusion: The diagnostic performance of TRODs evaluated in this study does not meet European Union standards (Se = 100%; Sp > 99.5%). The Ministry of Health should promote large-scale validation of TRODs based on World Health Organization guidelines.