Performance – afrjcem.org

*^[1]Zouré, A. A., ¹Compaoré, T. R., ²Beré, J. A., ¹Sagna, T., ¹Soubeiga, S. T., ¹Dabiré, C., ¹Nikiema, A. R., ³Barro, N., and ¹Ouedraogo, H. G.

¹Department of Biomedical and Public Health, Institute of Health Sciences Research (IRSS/CNRST), 03 BP 7047 Ouagadougou 03, Burkina Faso

²Unité de Formation et de Recherche en Science et Technique (UFR/ST), Université Catholique de l’Afrique de l’Ouest Unité Universitaire à Bobo Dioulasso (UCAO/UUB)

³Laboratoire de Biologie Moléculaire, d’Epidémiologie et de Surveillance des Agents, Transmissibles par les

Aliments (LaBESTA), Centre de Recherche en Sciences Biologiques Alimentaires et Nutritionnelles (CRSBAN),

Université Joseph KI-ZERBO, Ouagadougou, Burkina Faso

*Correspondence to: abdouazaque@gmail.com; +22625363215; ORCiD: //orcid.org/0000 –0002 –9423 –024X

Abstract:

Background: The extraction step of the viral material of the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) influences the quality of reverse transcriptase-polymerase chain reaction (RT-PCR) results in diagnosis of coronavirus disease 2019 (COVID-19). The purpose of this cross-sectional study was to evaluate the diagnostic performance of the automated extraction system “KingFisher Flex Purification System 96 (ThermoFisher)” compared to the manual method with the “QIAamp Viral RNA Mini Kit (Qiagen)”.

Methodology: From October to December 2020, comparative diagnostic evaluation of two methods of SARSCoV-2 RNA extraction methods was conducted on 159 fresh and 120 frozen nasopharyngeal and oropharyngeal specimens collected from travellers and suspected cases or contacts of COVID-19 patients in Burkina Faso. The FastPlexTM Triplex 1-Step COVID 19 Detection Kit (RT-PCR, RNA extraction free) (Precigenome LLC) was used to amplify on the same PCR plate, RNA extracts from manual QIAamp Viral RNA Mini Kit and automated KingFisher Flex Purification System 96 (ThermoFisher) using the QuantStudio5 thermal cycler (Applied Biosystems). Analysis of the diagnostic performance of the SARS-CoV-2 RT-PCR assay following RNA extraction by the two methods was done using an online OpenEpi software. Continue reading “Comparative evaluation of automated KingFisher Flex Purification System 96 (ThermoFisher Scientific) and manual QIAamp Viral RNA Mini Kit (Qiagen) extraction methods for SARS-CoV-2”

*1,2Salou, M., 1Ehlan, A., 2Dossim, S., 1Ali-Edje, K., 1Ouro-Medeli, A., 1Douffan, M., and 1,3Dagnra, A.

1National Reference Center for HIV and STIs (CNR HIV/STI)

2Department of Pharmaceutical Sciences, Faculty of Health Sciences, University of Lomé, Togo

3Department of Basic Sciences, Faculty of Health Sciences, University of Lomé, Togo *Correspondence to: mounerous@gmail.com, msalou@univ-lome.tg

Abstract:
Background: Several in vitro diagnostic (IVD) test kits for hepatitis B surface antigen (HBsAg) are commercially available. The question is whether they are performing well for both screening and diagnosis or not? Thus, this study aimed to evaluate the performance of six commercially available HBsAg detection kits in Togo.

Methods: This study was conducted at the National Reference Center for HIV/STI testing in Lomé (CNR-VIH/IST), Togo. Reference sera used for the assessment were collected from blood donors and patients with history of hepatitis B viral (HBV) infection between 2008 and 2014, and includes 200 non-reactive HBsAg and 150 reactive HBsAg sera that were confirmed with a reference method which consisted of the combination of an ELISA, a RDT, and a molecular test. Four ELISA kits (EKOlab ELISA-HBsAg; HEPALISA ULTRA; HEPALISA; Murex AgHBs Version 3) and two RDTs kits (ACON AgHBs and OnSite HBsAg Rapid Test-Cassette) were then evaluated using these serum samples. The EPI-INFO software version 7.2 was used to determine the 95% confidence interval and performed statistical analysis.

Results: Reference serum samples were collected from the population with 65.0% under 40 years of age and 61.2% males. The sensitivity of the 4 ELISA tests compared to the reference method was 100%. Apart from the HEPALISA test with a specificity of 100.0%, the specificity of the other three ELISA tests (Murex HBsAg version 3, HEPALISA ULTRA and EKOlab ELISA-HBsAg) were 98.4%, 97.3% and 91.8% respectively. For the RDTs, the sensitivity of ACON HBsAg and OnSite HBsAg Rapid Test-Cassette was 70.0% and 95.6% respectively while the specificity was 100.0% for both.

Conclusion: The ELISA tests evaluated were more sensitive than the RDTs, and HEPALISA test was the most efficient. Of the two RDTs, the OnSite HBsAg Rapid Test-Cassette was more sensitive. Our findings highlight the need for onsite verification of in vitro diagnostic kits for qualitative detection of hepatitis B surface antigen before their routine use in Togo.

Keywords: HBV, HBsAg, Performance, IVD test

Received Aug 16, 2019; Revised March 27, 2020; Accepted March 28, 2020

Copyright 2020 AJCEM Open Access. This article is licensed and distributed under the terms of the Creative Commons Attrition 4.0 International License <a rel=”license” href=”//creativecommons.org/licenses/by/4.0/”, which permits unrestricted use, distribution and reproduction in any medium, provided credit is given to the original author(s) and the source.

Évaluation des performances de six kits de diagnostic in vitro pour la détection qualitative de l’antigène de surface du virus de l’hépatite B (HBsAg) dans le sérum ou le plasma humain à Lomé, Togo

*1,2Salou, M., 1Ehlan, A., 2Dossim, S., 1Ali-Edje, K., 1Ouro-Medeli, A., 1Douffan, M., et 1,3Dagnra, A. Continue reading “Assessment of the performance of six in vitro diagnostic kits for qualitative detection of hepatitis B virus surface antigen (HBsAg) in human serum or plasma in Lomé, Togo”