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

作　　者：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 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(Department of Clinical Biology, University of Kinshasa, Kinshasa, Democratic Republic of the Congo;Department of Internal Medicine, University of Kinshasa, Kinshasa, Democratic Republic of the Congo;Department of Public Health, Lomo University Research, Kinshasa, Democratic Republic of the Congo;Department of Family Medicine and Primary Care, Protestant University of Congo, Congo, Democratic Republic of the Congo)

机构地区：[1]Department of Clinical Biology, University of Kinshasa, Kinshasa, Democratic Republic of the Congo [2]Department of Internal Medicine, University of Kinshasa, Kinshasa, Democratic Republic of the Congo [3]Department of Public Health, Lomo University Research, Kinshasa, Democratic Republic of the Congo [4]Department of Family Medicine and Primary Care, Protestant University of Congo, Congo, Democratic Republic of the Congo

出　　处：《Open Journal of Medical Microbiology》2021年第4期308-322,共15页医学微生物学（英文）

摘　　要：<b><span style="font-family:Verdana;">Background and Purpose:</span></b><span style="font-family:""><span style="font-family:Verdana;"> 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. </span><b><span style="font-family:Verdana;">Methods:</span></b><span style="font-family:Verdana;"> 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. </span><b><span style="font-family:Verdana;">Results:</span></b><span style="font-family:Verdana;"> 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%. </span><b><span style="font-family:Verdana;">Conclusion:</span></b><span style="font-family:Verdana;"> The diagnostic performance of TRODs evaluated in this study does not meet European Union standards (Se = 100%;Sp</span></span><span style="font-family:""> </span><span style="font-family:Verdana;">> 99.5%). The Ministry of Health should promote large-scale validation of TRODs based on World Health Organization guidelines.<b><span style="font-family:Verdana;">Background and Purpose:</span></b><span style="font-family:""><span style="font-family:Verdana;"> 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. </span><b><span style="font-family:Verdana;">Methods:</span></b><span style="font-family:Verdana;"> 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. </span><b><span style="font-family:Verdana;">Results:</span></b><span style="font-family:Verdana;"> 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%. </span><b><span style="font-family:Verdana;">Conclusion:</span></b><span style="font-family:Verdana;"> The diagnostic performance of TRODs evaluated in this study does not meet European Union standards (Se = 100%;Sp</span></span><span style="font-family:""> </span><span style="font-family:Verdana;">> 99.5%). The Ministry of Health should promote large-scale validation of TRODs based on World Health Organization guidelines.

关 键 词：HCV TROD Diagnostic Performance Screening SEROPREVALENCE 

分 类 号：TP3[自动化与计算机技术—计算机科学与技术]