tetano
Editor, Senior Moderator
Heliyon
. 2021 Nov;7(11):e08455.
doi: 10.1016/j.heliyon.2021.e08455. Epub 2021 Nov 22.
Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh
Md Mahfuzur Rahman[SUP] 1 [/SUP], Ananya Ferdous Hoque[SUP] 1 [/SUP], Yeasir Karim[SUP] 1 [/SUP], Zannat Kawser[SUP] 2 [/SUP], Abu Bakar Siddik[SUP] 2 [/SUP], Mariya Kibtiya Sumiya[SUP] 1 [/SUP], Ayesha Siddika[SUP] 1 [/SUP], Md Shaheen Alam[SUP] 1 [/SUP], Ahmed Nawsher Alam[SUP] 3 [/SUP], Muntasir Alam[SUP] 1 [/SUP], Mohammad Enayet Hossain[SUP] 1 [/SUP], Sayera Banu[SUP] 1 [/SUP], Firdausi Qadri[SUP] 1 [/SUP], Tahmina Shirin[SUP] 3 [/SUP], Mustafizur Rahman[SUP] 1 [/SUP], Mohammed Ziaur Rahman[SUP] 1 [/SUP]
Affiliations
Abstract
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.
Keywords: Bangladesh; COVID-19; Clinical evaluation; RT-PCR; Rapid antigen test; SARS-CoV-2.
. 2021 Nov;7(11):e08455.
doi: 10.1016/j.heliyon.2021.e08455. Epub 2021 Nov 22.
Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh
Md Mahfuzur Rahman[SUP] 1 [/SUP], Ananya Ferdous Hoque[SUP] 1 [/SUP], Yeasir Karim[SUP] 1 [/SUP], Zannat Kawser[SUP] 2 [/SUP], Abu Bakar Siddik[SUP] 2 [/SUP], Mariya Kibtiya Sumiya[SUP] 1 [/SUP], Ayesha Siddika[SUP] 1 [/SUP], Md Shaheen Alam[SUP] 1 [/SUP], Ahmed Nawsher Alam[SUP] 3 [/SUP], Muntasir Alam[SUP] 1 [/SUP], Mohammad Enayet Hossain[SUP] 1 [/SUP], Sayera Banu[SUP] 1 [/SUP], Firdausi Qadri[SUP] 1 [/SUP], Tahmina Shirin[SUP] 3 [/SUP], Mustafizur Rahman[SUP] 1 [/SUP], Mohammed Ziaur Rahman[SUP] 1 [/SUP]
Affiliations
- PMID: 34841119
- PMCID: PMC8606316
- DOI: 10.1016/j.heliyon.2021.e08455
Abstract
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.
Keywords: Bangladesh; COVID-19; Clinical evaluation; RT-PCR; Rapid antigen test; SARS-CoV-2.