TITLE:
Diagnostic Performance of SD Bioline, Accurate, Fortress and Encode Compared to the Mindray CLIA 1200i Test in Volunteer Blood Donors at Kinshasa University Hospital
AUTHORS:
Alain Vandersal Salaboni Mungezi, Benjamin Longo-Mbenza, Jacques Bikaula Ngwidiwo, Héritier Mawalala Malengele, Charles Mbendi Nlombi, Antoine Tshimpi Wola Yaba, Bienvenu Kuyangisa Boloko, Aliocha Nkodila Natuhoyila, Mireille Solange Nganga Nkanga
KEYWORDS:
HCV, TROD, Diagnostic Performance, Screening, Seroprevalence
JOURNAL NAME:
Open Journal of Medical Microbiology,
Vol.11 No.4,
December
1,
2021
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.