Year: 2024 | Month: July | Volume: 14 | Issue: 7 | Pages: 241-244
DOI: https://doi.org/10.52403/ijhsr.20240732
Evaluation of a Serological Assay to Determine the Immunoglobulin Status in SARS-CoV-2 Infected Patients Reveals a Low Performance
Samira Zoa Assoumou1,2, Berthe Iroungou3, Krystina Mengue Me Ngou-Milama4, Aurore Bouassa Bouassa3, Ludovic Mewono2,5, Rodrigue Mintsa-Nguema2,6, Paulin Essone4,7, Pamela Moussavou3, Joel Fleury Djoba Siawaya8, Armel Mintsa4
1Département de Bactériologie-Virologie, Université des Sciences de la Santé, Libreville, Gabon
2Laboratoire Professeur Daniel Gahouma, Libreville, Gabon
3Unité Mixte de Recherches VIH et Maladies infectieuses associées, Centre International de Recherches Médicales de Franceville et le Service de Santé Militaire (UMR CIRMF-SSM), Libreville, Gabon
4Laboratoire National de Santé Publique de Libreville, Gabon
5Departement des Sciences de la vie et de la Terre, Ecole Normale Supérieure, Libreville, Gabon
6Institut de Recherche en Ecologie Tropicale, Centre National de la Recherche Scientifique et Technologique, Libreville, Gabon
7Centre de Recherche Médicale de Lambaréné, Gabon
8 Centre Hospitalo-Universitaire Mère-enfant, Libreville, Gabon.
Corresponding Author: Samira ZOA ASSOUMOU
ABSTRACT
Introduction: Emergence of SARS‐CoV‐2 has promoted the development of several serological tests for antibody detection. The external evaluation of their performance is needed before use. This study aims at assessing the performance of a Commercial lateral flow device for IgM/IgG Antibody SARS-CoV-2 detection.
Methods: One‐hundred twenty-two samples SARS-CoV-2 positive by RT-PCR were used. A serological test (Ichroma2 COVID-19 Ab kit) was used as gold standard. All these samples were tested > 14 day post symptoms onset. Among the 122 samples used after testing with gold standard: 41 were IgM / IgG positive, 43 IgM positive / IgG negative and 38 IgM negative / igG positive.
Results: The commercial test evaluated shows a sensitivity and specificity of 2.4% (95% confidence interval [CI]: 0.0%-5.7%) and 100% for IgM and 10.1% (95% confidence interval [CI]: 3.5%-16.8%) and 100% for IgG.
Conclusion: Our findings demonstrate the crucial importance to evaluate performance of an assay before implementing.
Key words: [Serological methods, Immunochromatography, performance, SARS-CoV-2, COVID-19]