Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh
The rapid and early detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections is key to control the current Coronavirus disease 2019 (COVID-19) pandemic. The present study was conducted to clinically evaluate a rapid diagnostic test (RDT) kit, Standard Q COVID-19 Ag Test (...
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2021
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oai:doaj.org-article:658dff89d7cd408ebe9d17c594fcb6862021-12-02T05:03:18ZClinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh2405-844010.1016/j.heliyon.2021.e08455https://doaj.org/article/658dff89d7cd408ebe9d17c594fcb6862021-11-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2405844021025585https://doaj.org/toc/2405-8440The rapid and early detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections is key to control the current Coronavirus disease 2019 (COVID-19) pandemic. The present study was conducted to clinically evaluate a rapid diagnostic test (RDT) kit, Standard Q COVID-19 Ag Test (SD Biosensor®, Republic of Korea), with reference to the standard real-time RT-PCR for detection of COVID-19 cases in Bangladesh. Nasopharyngeal swabs were taken from 900 COVID-19 suspected patients. Among them, 34.11% (n = 307) were diagnosed as COVID-19 cases by RT-PCR assay, of which 85% (n = 261) were also detectable using the RDT. The overall sensitivity and specificity of the RDT compared to RT-PCR were 85.02% and 100%, respectively, regardless of age, sex, and type of SARS-CoV-2 variants. Most of the RT-PCR positive cases (94%) were found within the first five days of disease onset, and the sensitivity of RDT was 85.91% for the same samples. The positive predictive value (PPV) of the RDT was 100%, and the negative predictive value (NPV) was 92.8%. The Cohen's kappa value of 0.882 indicated excellent agreement between the RDT and RT-PCR assays. The findings of this study showed the potential use of SARS-CoV-2 antigen-based RDT to expedite the diagnostic process and onward COVID-19 management in Bangladesh.Md. Mahfuzur RahmanAnanya Ferdous HoqueYeasir KarimZannat KawserAbu Bakar SiddikMariya Kibtiya SumiyaAyesha SiddikaMd. Shaheen AlamAhmed Nawsher AlamMuntasir AlamMohammad Enayet HossainSayera BanuFirdausi QadriTahmina ShirinMustafizur RahmanMohammed Ziaur RahmanElsevierarticleSARS-CoV-2COVID-19Clinical evaluationRapid antigen testRT-PCRBangladeshScience (General)Q1-390Social sciences (General)H1-99ENHeliyon, Vol 7, Iss 11, Pp e08455- (2021) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
SARS-CoV-2 COVID-19 Clinical evaluation Rapid antigen test RT-PCR Bangladesh Science (General) Q1-390 Social sciences (General) H1-99 |
| spellingShingle |
SARS-CoV-2 COVID-19 Clinical evaluation Rapid antigen test RT-PCR Bangladesh Science (General) Q1-390 Social sciences (General) H1-99 Md. Mahfuzur Rahman Ananya Ferdous Hoque Yeasir Karim Zannat Kawser Abu Bakar Siddik Mariya Kibtiya Sumiya Ayesha Siddika Md. Shaheen Alam Ahmed Nawsher Alam Muntasir Alam Mohammad Enayet Hossain Sayera Banu Firdausi Qadri Tahmina Shirin Mustafizur Rahman Mohammed Ziaur Rahman Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh |
| description |
The rapid and early detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections is key to control the current Coronavirus disease 2019 (COVID-19) pandemic. The present study was conducted to clinically evaluate a rapid diagnostic test (RDT) kit, Standard Q COVID-19 Ag Test (SD Biosensor®, Republic of Korea), with reference to the standard real-time RT-PCR for detection of COVID-19 cases in Bangladesh. Nasopharyngeal swabs were taken from 900 COVID-19 suspected patients. Among them, 34.11% (n = 307) were diagnosed as COVID-19 cases by RT-PCR assay, of which 85% (n = 261) were also detectable using the RDT. The overall sensitivity and specificity of the RDT compared to RT-PCR were 85.02% and 100%, respectively, regardless of age, sex, and type of SARS-CoV-2 variants. Most of the RT-PCR positive cases (94%) were found within the first five days of disease onset, and the sensitivity of RDT was 85.91% for the same samples. The positive predictive value (PPV) of the RDT was 100%, and the negative predictive value (NPV) was 92.8%. The Cohen's kappa value of 0.882 indicated excellent agreement between the RDT and RT-PCR assays. The findings of this study showed the potential use of SARS-CoV-2 antigen-based RDT to expedite the diagnostic process and onward COVID-19 management in Bangladesh. |
| format |
article |
| author |
Md. Mahfuzur Rahman Ananya Ferdous Hoque Yeasir Karim Zannat Kawser Abu Bakar Siddik Mariya Kibtiya Sumiya Ayesha Siddika Md. Shaheen Alam Ahmed Nawsher Alam Muntasir Alam Mohammad Enayet Hossain Sayera Banu Firdausi Qadri Tahmina Shirin Mustafizur Rahman Mohammed Ziaur Rahman |
| author_facet |
Md. Mahfuzur Rahman Ananya Ferdous Hoque Yeasir Karim Zannat Kawser Abu Bakar Siddik Mariya Kibtiya Sumiya Ayesha Siddika Md. Shaheen Alam Ahmed Nawsher Alam Muntasir Alam Mohammad Enayet Hossain Sayera Banu Firdausi Qadri Tahmina Shirin Mustafizur Rahman Mohammed Ziaur Rahman |
| author_sort |
Md. Mahfuzur Rahman |
| title |
Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh |
| title_short |
Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh |
| title_full |
Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh |
| title_fullStr |
Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh |
| title_full_unstemmed |
Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh |
| title_sort |
clinical evaluation of sars-cov-2 antigen-based rapid diagnostic test kit for detection of covid-19 cases in bangladesh |
| publisher |
Elsevier |
| publishDate |
2021 |
| url |
https://doaj.org/article/658dff89d7cd408ebe9d17c594fcb686 |
| work_keys_str_mv |
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