Evaluation of a Rapid Diagnostic Test, Boson Biotech SARS CoV-2 Ag, for the Detection of SARS-CoV-2 in Gabon  

作　　者：Samira Zoa Assoumou Ulrich Leger Davy Mouangala Ludovic Mewono Davy-Christ Angoune Ndong Guy Paterne Malonga Mbembo Nely Meungang Alain Moutsinga Elvyre Anita Mbongo Kama Rodrigue Mintsa Nguema Samira Zoa Assoumou;Ulrich Leger Davy Mouangala;Ludovic Mewono;Davy-Christ Angoune Ndong;Guy Paterne Malonga Mbembo;Nely Meungang;Alain Moutsinga;Elvyre Anita Mbongo Kama;Rodrigue Mintsa Nguema(Dpartement de Bactriologie-Virologie, Universit des Sciences de la Sant, Libreville, Gabon;Laboratoire Professeur Daniel Gahouma, Libreville, Gabon;Departement des Sciences de la vie et de la Terre, Ecole Normale Suprieure, Libreville, Gabon;Centre de sant de Glass, Libreville, Gabon;Laboratoire National de Sant Publique, Libreville, Gabon;Dpartement de Biologie et Ecologie Animale, Centre National de la Recherche Scientifique et Technologique, Libreville, Gabon;Laboratoire dEcologie des Maladies Transmissibles (LEMAT), Universit Libreville Nord (ULN), Libreville, Gabon)

机构地区：[1]Dpartement de Bactriologie-Virologie, Universit des Sciences de la Sant, Libreville, Gabon [2]Laboratoire Professeur Daniel Gahouma, Libreville, Gabon [3]Departement des Sciences de la vie et de la Terre, Ecole Normale Suprieure, Libreville, Gabon [4]Centre de sant de Glass, Libreville, Gabon [5]Laboratoire National de Sant Publique, Libreville, Gabon [6]Dpartement de Biologie et Ecologie Animale, Centre National de la Recherche Scientifique et Technologique, Libreville, Gabon [7]Laboratoire dEcologie des Maladies Transmissibles (LEMAT), Universit Libreville Nord (ULN), Libreville, Gabon

出　　处：《Advances in Infectious Diseases》2024年第2期469-477,共9页传染病进展（英文）

摘　　要：1) Background: Rapid and acurate diagnostic testing for case identification, quarantine, and contact tracing is essential for managing the COVID 19 pandemic. Rapid antigen detection tests are available, however, it is important to evaluate their performances before use. We tested a rapid antigen detection of SARS-CoV-2, based on the immunochromatography (Boson Biotech SARS-CoV-2 Ag Test (Xiamen Boson Biotech Co., Ltd., China)) and the results were compared with the real time reverse transcriptase-Polymerase chain reaction (RT-PCR) (Gold standard) results;2) Methods: From November 2021 to December 2021, samples were collected from symptomatic patients and asymptomatic individuals referred for testing in a hospital during the second pandemic wave in Gabon. All these participants attending “CTA Angondjé”, a field hospital set up as part of the management of COVID-19 in Gabon. Two nasopharyngeal swabs were collected in all the patients, one for Ag test and the other for RT-PCR;3) Results: A total of 300 samples were collected from 189 symptomatic and 111 asymptomatic individuals. The sensitivity and specificity of the antigen test were 82.5% [95%CI 73.8 - 89.3] and 97.9 % [95%CI 92.2 - 98.2] respectively, and the diagnostic accuracy was 84.4% (95% CI: 79.8 - 88.3%). The antigen test was more likely to be positive for samples with RT-PCR Ct values ≤ 32, with a sensitivity of 89.8%;4) Conclusions: The Boson Biotech SARS-CoV-2 Ag Test has good sensitivity and can detect SARS-CoV-2 infection, especially among symptomatic individuals with low viral load. This test could be incorporated into efficient testing algorithms as an alternative to PCR to decrease diagnostic delays and curb viral transmission.1) Background: Rapid and acurate diagnostic testing for case identification, quarantine, and contact tracing is essential for managing the COVID 19 pandemic. Rapid antigen detection tests are available, however, it is important to evaluate their performances before use. We tested a rapid antigen detection of SARS-CoV-2, based on the immunochromatography (Boson Biotech SARS-CoV-2 Ag Test (Xiamen Boson Biotech Co., Ltd., China)) and the results were compared with the real time reverse transcriptase-Polymerase chain reaction (RT-PCR) (Gold standard) results;2) Methods: From November 2021 to December 2021, samples were collected from symptomatic patients and asymptomatic individuals referred for testing in a hospital during the second pandemic wave in Gabon. All these participants attending “CTA Angondjé”, a field hospital set up as part of the management of COVID-19 in Gabon. Two nasopharyngeal swabs were collected in all the patients, one for Ag test and the other for RT-PCR;3) Results: A total of 300 samples were collected from 189 symptomatic and 111 asymptomatic individuals. The sensitivity and specificity of the antigen test were 82.5% [95%CI 73.8 - 89.3] and 97.9 % [95%CI 92.2 - 98.2] respectively, and the diagnostic accuracy was 84.4% (95% CI: 79.8 - 88.3%). The antigen test was more likely to be positive for samples with RT-PCR Ct values ≤ 32, with a sensitivity of 89.8%;4) Conclusions: The Boson Biotech SARS-CoV-2 Ag Test has good sensitivity and can detect SARS-CoV-2 infection, especially among symptomatic individuals with low viral load. This test could be incorporated into efficient testing algorithms as an alternative to PCR to decrease diagnostic delays and curb viral transmission.

关 键 词：SARS-CoV-2 Rapid Diagnostic Test EVALUATION COVID-19 ANTIGEN Performance 

分 类 号：O57[理学—粒子物理与原子核物理]