Évaluation des performances analytiques du test de diagnostic rapide ACCU-TELL® pour la détection des anticorps IgG anti-SARS-CoV-2 au Burkina Faso

Abstract

In countries with limited resources, access to molecular tools is severely restricted. The equipment is expensive and the personnel who can operate it are in short supply. Rapid tests are the ideal complement for diagnosing COVID-19. They enable rapid, portable, and cost-effective detection of infections. In countries with limited resources, such as Burkina Faso, these tests will provide an alternative to the current problems. However, diagnostic tools must be evaluated locally before they can be used on a large scale. This study aimed to assess the analytical performance of the Accu-Tell^®rapid test in Burkina Faso. This diagnostic tool evaluation study took place between June and December 2021. The study involved serum samples collected during a previous study in areas with no recorded cases at the inclusion date. The biological analyses were conducted at the Clinical Microbiology and Immunology Laboratory of the Institut de Recherche en Science de la Santé/Direction Régionale de l'Ouest (IRSS/DRO). We carried out IgG antibody testing using the SARS-CoV-2 (RBD) ELISA Kit, which is the gold standard, and the Accu-Tell^® TDR. A total of 1,425 samples were analyzed. Of these, 541 were positive with the gold standard (ELISA) and 193 with the TDR. This gives a sensitivity of 20.79%, a specificity of 90.79%, a positive predictive value of 58.03%, a negative predictive value of 65.17%, and a Kappa coefficient of 0.13%. The sensitivity and specificity of the Accu-Tell® RDT must be improved before it can be used.