COVID-19 Antigen Rapid Test Pen and how it works
The COVID-19 Antigen Rapid Test Pen is an in vitro immunoassay. The assay is for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from saliva samples. This test is intended for professional use only. The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease to which people are generally susceptible. Currently, the patients infected by the novel coronavirus are the primary source of infection. However, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days. Although, most commonly seen is 3 to 7 days. The main manifestations include fever, fatigue, and dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhoea are found in a few cases.
The COVID-19 Antigen Rapid Test Pen detects SARS-CoV-2 viral antigens through visual interpretation of colour development. Anti-SARS-CoV-2 antibodies are immobilized on the test region of the nitrocellulose membrane. Anti-SARS-CoV-2 antibodies conjugated to coloured particles are immobilized on the conjugated pad. A sample is added to the extraction buffer, which is optimised to release the SARS-CoV-2 antigens from the specimen. During testing, target antigens, if present in the saliva samples, will be released into the extraction buffer individually packed in the kit. Consequently, the extracted antigens will bind to anti-SARS-CoV-2 antibodies conjugated to coloured particles. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane. Subsequently, the complex will then be captured by the anti-SARSCoV-2 antibodies at the test region. Excess coloured particles are captured in the internal control zone.
COVID-19 Antigen Rapid Test Pen: The optimal procedure
Bring devices to room temperature (15~30˚C) before use
1. Remove the saliva collector from its packing. Label the tube with the patient’s identification. For the best results, the assay should be performed within two hours
2. Place the saliva collector in the mouth, hold for 2 minutes
3. Place the saliva collector vertically into the Extraction Buffer
4. Read the results at 15 minutes