Key Features and Values
- Qualitative detection of SARS-CoV-2 nucleocapsid antigen
- Fast and easy to use in point of care setting and near patient testing
- For use with nasopharyngeal or nasal swab samples
- No specialised equipment needed
- Rapid determination of current infection with SARS-CoV-2
- Result within 15 minutes
- Sensitivity: 98.32%
- Specificity: 99.60%
- Recognised by the European Commission as an acceptable test method for member states1
The Coronavirus Ag Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.
SARS-CoV-2 is a single-stranded RNA coronavirus2. Coronaviruses are composed of several proteins including the spike (S), envelope (E), membrane (M), and nucleocapsid (N)3. The spike glycoprotein of SARS-CoV-2 is a trimeric protein with each 180 kDa monomer consisting of 2 subunits (S1 and S2) which facilitate attachment and binding to the target cell4.
The viral infection causes a series of respiratory illness including severe respiratory syndrome, indicating the virus most likely infects respiratory epithelial cells and spreads mainly via respiratory tract from human to human2. Current epidemiological assessments indicate that the incubation period is 1 to 14 days, mostly 3 to 7 days. The main symptoms include fever, fatigue, a dry cough and loss of taste and / or smell; nasal congestion and other typical flu-like symptoms are also present in some cases.
The Coronavirus Ag Rapid Test Cassette (Swab) detects SARS-CoV-2 nucleocapsid antigen in test samples. This antigen is generally detectable in samples from the upper respiratory tract of infected individuals during the acute phase of the infection. Rapid diagnosis of SARS-CoV-2 infections support early identification of infected individuals allowing healthcare professionals to treat patients more efficiently and effectively. Such rapid identification of those infected by SARS-CoV-2 may also support mass screening efforts allowing faster initiation of contact tracing to help reduce the spread of the virus.
- Xiao F, Tang M, Zheng X, Liu Y, Li X, Shan H, Evidence for gastrointestinal infection of SARS-CoV-2, Gastroenterology (2020), doi: https://doi.org/10.1053/j.gastro.2020.02.055.
- Li, F., Li, W., Farzan, M., & Harrison, S. (2005). Structure of SARS coronavirus spike receptor-binding domain complexed with its 10.2210/pdb2ajf/pdb
- Ou, X., Liu, Y., Lei, X. et al. Characterization of spike glycoprotein of SARS-CoV-2 on virus entry and its immune cross-reactivity with SARS-CoV. Nat Commun 11, 1620 (2020).