tetano
Editor, Senior Moderator
Diagnostics (Basel)
. 2021 Dec 8;11(12):2300.
doi: 10.3390/diagnostics11122300.
Clinical Evaluation of a New Antigen-Based COVID-19 Rapid Diagnostic Test from Symptomatic Patients
Saiful Arefeen Sazed[SUP] 1 [/SUP], Mohammad Golam Kibria[SUP] 1 [/SUP], Mohammad Sharif Hossain[SUP] 1 [/SUP], Md Fahad Zamil[SUP] 1 [/SUP], Pranob Chandra Adhikary[SUP] 1 [/SUP], Mohammad Enayet Hossain[SUP] 1 [/SUP], Dilruba Ahmed[SUP] 1 [/SUP], Rashidul Haque[SUP] 1 [/SUP], Mohammad Shafiul Alam[SUP] 1 [/SUP]
Affiliations
Abstract
Accurate diagnosis at the right moment is the prerequisite for treatment of any disease. Failure to correctly diagnose a disease can result in highly detrimental effects, unmistakably a crucial factor during the COVID-19 pandemic. RT-PCR is the gold standard for COVID-19 detection while there are other test procedures available, such as LAMP, X-Ray, and ELISA. However, these tests are expensive, require sophisticated equipment and a highly trained workforce, and multiple hours or even days are often required to obtain the test results. A rapid and cheap detection system can thus render a solution to the screening system on a larger scale and be added as an aid to the current detection processes. Recently, some rapid antigen-based COVID-19 tests devices have been developed and commercialized. In this study, we evaluated the clinical performance of a new rapid detection device (OnSite[SUP]®[/SUP] COVID-19 Ag Rapid Test by CTK Biotech Inc., Poway, CA, USA) on COVID-19 symptomatic patients (n = 380). The overall sensitivity and specificity were 91.0% (95% CI: 84.8-95.3%) and 99.2% (95% CI: 97.1-99.9), against gold standard RT-PCR. The kit was capable of detecting patients even after 06 days of onset of symptoms and the sensitivity can be maximized to 98% in samples with an average RT-PCR Ct ≤ 26.48, demonstrating a high potential of the kit for clinical diagnosis of symptomatic patients in healthcare facilities.
Keywords: 2019 novel coronavirus; COVID-19; PCR; SARS-CoV-2; diagnostics; pandemic; rapid antigen detection; rapid test; surveillance.
. 2021 Dec 8;11(12):2300.
doi: 10.3390/diagnostics11122300.
Clinical Evaluation of a New Antigen-Based COVID-19 Rapid Diagnostic Test from Symptomatic Patients
Saiful Arefeen Sazed[SUP] 1 [/SUP], Mohammad Golam Kibria[SUP] 1 [/SUP], Mohammad Sharif Hossain[SUP] 1 [/SUP], Md Fahad Zamil[SUP] 1 [/SUP], Pranob Chandra Adhikary[SUP] 1 [/SUP], Mohammad Enayet Hossain[SUP] 1 [/SUP], Dilruba Ahmed[SUP] 1 [/SUP], Rashidul Haque[SUP] 1 [/SUP], Mohammad Shafiul Alam[SUP] 1 [/SUP]
Affiliations
- PMID: 34943537
- DOI: 10.3390/diagnostics11122300
Abstract
Accurate diagnosis at the right moment is the prerequisite for treatment of any disease. Failure to correctly diagnose a disease can result in highly detrimental effects, unmistakably a crucial factor during the COVID-19 pandemic. RT-PCR is the gold standard for COVID-19 detection while there are other test procedures available, such as LAMP, X-Ray, and ELISA. However, these tests are expensive, require sophisticated equipment and a highly trained workforce, and multiple hours or even days are often required to obtain the test results. A rapid and cheap detection system can thus render a solution to the screening system on a larger scale and be added as an aid to the current detection processes. Recently, some rapid antigen-based COVID-19 tests devices have been developed and commercialized. In this study, we evaluated the clinical performance of a new rapid detection device (OnSite[SUP]®[/SUP] COVID-19 Ag Rapid Test by CTK Biotech Inc., Poway, CA, USA) on COVID-19 symptomatic patients (n = 380). The overall sensitivity and specificity were 91.0% (95% CI: 84.8-95.3%) and 99.2% (95% CI: 97.1-99.9), against gold standard RT-PCR. The kit was capable of detecting patients even after 06 days of onset of symptoms and the sensitivity can be maximized to 98% in samples with an average RT-PCR Ct ≤ 26.48, demonstrating a high potential of the kit for clinical diagnosis of symptomatic patients in healthcare facilities.
Keywords: 2019 novel coronavirus; COVID-19; PCR; SARS-CoV-2; diagnostics; pandemic; rapid antigen detection; rapid test; surveillance.