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Evaluation de deux tests de diagnostic antigénique du COVID-19: BIOSYNEX® COVID-19 Ag BSS et BIOSYNEX® COVID-19 Ag+ BSS comparés à la PCR AmpliQuick® SARS-CoV-2.
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- Author(s): Ngaba, Guy Pascal1,2; Mireille Kalla, Ginette Claude3; Nguedia Assob, Jules Clément1; Njouendou, Abdel Jelil4; Jembe, Christian Nelly5; Télesphore Mboudou, Emile2,3; Keou, François-Xavier Mbopi-3,6
- Source:
Pan African Medical Journal. May-Aug2021, Vol. 39, p1-11. 11p.- Subject Terms:
- Source:
- Additional Information
- Alternate Title: Evaluation of two COVID-19 antigenic diagnostic tests: BIOSYNEX® COVID-19 Ag BSS and BIOSYNEX® COVID-19 Ag + BSS compared to AmpliQuick® SARS- CoV-2 PCR.
- Subject Terms:
- Subject Terms:
- Abstract: Introduction: the COVID-19 pandemic causes biological diagnostic problems that remain relevant in low-income countries in general and in Cameroon in particular. Rapids tests that reliably detect SARS- CoV-2 virus antigen present themselves as an important alternative in several contexts. The objective of our study was to evaluate the diagnostic performance of two rapid diagnostic tests BIOSYNEX® COVID-19 Ag BSS and BIOSYNEX® COVID-19 Ag + BSS, compared to each other and to the AmpliQuick® SARS-CoV-2 PCR test. Methods: a cross-sectional and comparative study was carried out from April 27 to May 29, 2021 in the city of Douala in Cameroon. The samples consisted of nasopharyngeal swabs received at the molecular biology laboratory of the Douala Gyneco-obstetric and pediatric hospital, whatever their origin. The socio-demographic parameters (age, profession, football players, travelers, others), marital status, nationality), comorbidity and known status of COVID-19, were recorded on the collection sites. The main collection sites were the Deïdo Health District and the Douala Gyneco-Obstetric and Pediatric Hospital. We performed the diagnosis of COVID-19 using the rapid diagnostic test (RDT) BIOSYNEX® COVID-19 Ag BSS and RDT BIOSYNEX® COVID-19 Ag + BSS compared to each other and to the AmpliQuick® SARS-CoV-2 polymerase chain reaction (PCR) test on each sample. Statistical analysis of the data was performed using Microsoft Excel and SPSS version 17 software. To determine the sensitivity of the two RDTs, the Bayesian latent class model was performed on the median with a 95% confidence interval with p<0.05 as the significant level. An ethical clearance was sought and obtained from the University of Douala Institutional Ethics Committee. Results: a total of 1813 participants were included in our study, with a predominance of men (1226, 68.68 %) and the most represented age group was that of 31 to 40 years (568, 31.33 %). Most of the participants were married (888, 53.46%) and only a few had a known COVID-19 status (75, 5.47%). The two rapid tests on our study population show much closed COVID-19 prevalence values, respectively 2.03 for BIOSYNEX® COVID-19 Ag BSS and 2.17 for BIOSYNEX® COVID-19 Ag + BSS. RDT BIOSYNEX® COVID-19 Ag + BSS showed higher sensitivity 94.1% vs. 87.5% for RDT BIOSYNEX® COVID-19 Ag BSS with almost identical specificity 98.9% for RDT BIOSYNEX® COVID-19 Ag + BSS vs. 98.7% for RDT BIOSYNEX® COVID-19 Ag BSS compared to AmpliQuick® SARS-CoV-2. BIOSYNEX® COVID-19 Ag + BSS RDT showed a negative predictive value of 99.9% compared to BIOSYNEX® COVID-19 Ag BSS RDT. There is a 99.9% agreement between the RDT BIOSYNEX® COVID-19 Ag BSS and the RDT BIOSYNEX® COVID-19 Ag + BSS. Conclusion: the RDT BIOSYNEX®COVID-19 Ag + BSS and RDT BIOSYNEX® COVID-19 Ag BSS can be used for the diagnosis of SARS-CoV-2 and can have an important contribution in the context of mass screenings and screening in remote areas. [ABSTRACT FROM AUTHOR]
- Abstract: Introduction: la pandémie à COVID-19 pose des problèmes de diagnostic biologique qui restent d ́actualité dans les pays à faible revenu en général et au Cameroun en particulier. Les tests rapides détectant l ́antigène du virus SARS-CoV-2 fiables se présentent comme une alternative importante. L ́objectif de notre étude était d ́évaluer les performances diagnostiques des tests de diagnostic rapide BIOSYNEX®COVID-19 Ag BSS et BIOSYNEX®COVID-19 Ag+ BSS comparés entre eux, puis comparés au test PCR AmpliQuick® SARS-CoV-2. Méthodes: une étude transversale et comparative a été menée du 27 avril au 29 mai 2021 dans la ville de Douala au Cameroun. Les échantillons étaient constitués de prélèvements nasopharyngés reçus au laboratoire de biologie moléculaire de l'Hôpital Gynéco-Obstétrique et Pédiatrique de Douala. Les paramètres sociodémographiques (âge, profession (footballeurs, voyageurs, autres), statut matrimonial, nationalité), comorbidité et statut connu du COVID-19, ont été enregistrés sur les sites de collecte. Les principaux sites de collecte étaient le District de santé de Deïdo et l'Hôpital Gynéco- Obstétrique et Pédiatrique de Douala. Nous avons effectué le diagnostic du COVID-19 en utilisant les tests de diagnostic rapide BIOSYNEX® COVID-19 Ag BSS et BIOSYNEX® COVID-19 Ag+ BSS que nous avons d ́abord comparé entre eux, puis nous les avons comparés au test PCR AmpliQuick®SARS-CoV-2 sur chaque échantillon. L'analyse statistique des données a été réalisée à l'aide des logiciels Microsoft Excel et SPSS version 17. Pour déterminer la sensibilité des deux tests de diagnostic rapide, le modèle bayésien de classe latente a été réalisé sur la médiane avec un intervalle de confiance à 95 %, et p<0,05 comme seuil de significativité. Une autorisation éthique a été demandée et obtenue auprès du Comité d'éthique Institutionnel (CEI) de l'Université de Douala. Résultats: un total de 1813 participants a été inclus dans cette étude, avec une prédominance d'hommes (1226, 68,68 %) et la tranche d'âge la plus représentée était celle des 31 à 40 ans (568, 31,33 %). La plupart des participants étaient mariés (888, 53,46%) et seuls quelques-uns avaient un statut COVID-19 connu (75, 5,47%). Les prévalences de COVID-19 retrouvées avec les deux tests de diagnostic rapide étaient de 2,03 et 2,17 pour BIOSYNEX® COVID-19 Ag BSS et BIOSYNEX®COVID-19 Ag + BSS respectivement. Une sensibilité de 94,1% a été retrouvée pour le test BIOSYNEX® COVID-19 Ag BSS tandis que pour le test BIOSYNEX® COVID-19 Ag + BSS, la sensibilité était de 87,5%. La spécificité était de 98,9% et 98,7% pour le test BIOSYNEX® COVID-19 Ag + BSS et BIOSYNEX® COVID-19 Ag BSS respectivement par rapport à AmpliQuick® SARS-CoV-2. Le test BIOSYNEX® COVID-19 Ag + BSS a montré une valeur prédictive négative de 99.9% par rapport au test BIOSYNEX® COVID-19 Ag BSS. Un accord de 99,9% a été retrouvé entre les tests BIOSYNEX® COVID-19 Ag BSS et BIOSYNEX® COVID-19 Ag + BSS. Conclusion: les tests de diagnostic rapide BIOSYNEX® COVID-19 Ag + BSS et BIOSYNEX® COVID-19 Ag BSS peuvent être utilisés pour le diagnostic du SARS-CoV-2 et peuvent être d ́un apport important dans le dépistage de masse et le dépistage en zones reculées. [ABSTRACT FROM AUTHOR]
- Abstract: Copyright of Pan African Medical Journal is the property of Pan African Medical Journal and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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