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.
Highlights
IntroductionThe hepatitis C virus (HCV) is one of the major causes of morbidity (prevalence and incidence) and mortality in the world
The hepatitis C virus (HCV) is one of the major causes of morbidity and mortality in the world
This study examined the level of diagnostic performance of SD Bioline, Encode, Fortress and Accurate compared to the chemiluminescence immunoassay
Summary
The hepatitis C virus (HCV) is one of the major causes of morbidity (prevalence and incidence) and mortality in the world. WHO recognizes HCV infection as a public health problem in the general population [2], and among voluntary blood donors (DBS) [3]. In the Democratic Republic of Congo (DRC), the prevalence of HCV in blood donors ranged from 2.3% to 13.24% in the HD population [3] [4]. Faced with this situation, screening for chronic HCV infection is becoming a public health challenge, especially with the therapeutic revolution in hepatitis C and with the arrival in 2010 of new direct-acting antivirals (DAAs) [5]. The Ministry of Health should promote large-scale validation of TRODs based on World Health Organization guidelines
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