Key Features and Values
- Qualitative detection of SARS-CoV-2 nucleocapsid antigen
- Fast and easy method for self use
- For use with nasal (or nasopharyngeal) swab samples
- No specialised equipment needed
- Rapid determination of current infection with SARS-CoV-2
- Result within 15 minutes
- Sensitivity: 95.06%
- Specificity: 99.62%
- Recognised by the European Commission as an acceptable test method for member states1
The product is intended for the qualitative detection of antigen against SARS-CoV-2 in clinical samples (nasal swab).
Coronavirus, as a large virus family, is a single positive stranded RNA virus with envelope. The virus is known to cause major illnesses such as colds, Middle East Respiratory Syndrome (MERS), and Severe Acute Respiratory Syndrome (SARS). The core protein of SARS-CoV-2 is the N protein (Nucleocapsid), which is a protein component located inside the virus. It is relatively conserved among β-coronaviruses and is often used as a tool for the diagnosis of coronaviruses. ACE2, as a key receptor for SARS-CoV-2 to enter cells, is of great significance for the research of viral infection mechanism.
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; with nasal congestion and other typical flu-like symptoms presenting in some cases.
The SARS-CoV-2 Antigen Rapid Test Kit detects the presence of 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 and initiation of contact tracing to 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.