The COVID-19 Antigen Rapid Test Pen detects SARS-CoV-2 viral nucleoprotein antigens from saliva samples through visual interpretation of color development.
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 colored particles.
As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by the anti-SARS-CoV-2 antibodies at the test region. Excess colored particles are captured in the internal control zone. The presence of a colored band in the test region indicates a positive result for the SARS-CoV-2 viral antigens, while its absence indicates a negative result. A colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane.
Full Coverage Testing
During the period a person is infected with the SARS-CoV-2 virus two types of antibodies appear -Immunoglobulin M (IgM) that starts to appear in the first few days after infection and that lasts for a limited period of time, and Immunoglobulin G (IgG) that appears later but has a much more long-lasting effect and persists in the body for extended periods and in some cases for life.
The following graph shows the profiles of IgM and IgG development following infection by COVID-19.
Graph 1: The development of IgM and IgG antibodies in the blood
The COVID-19 Antigen Rapid Test Pen In combination with the Lyher SARS-CoV-2 IgM/IgG Antibody Test can be used for full coverage testing.
The COVID-19 Antigen Rapid Test Pen is an in vitro immunoassay that is used for the direct and qualitative detection of SARS-CoV-2 in the body at the moment of testing, while the Lyher SARS-CoV-2 IgM/IgG Antibody assay (diagnostic kit) identifies the presence of coronavirus antibodies in the blood of patients who have potentially recovered from coronavirus infection. The Antibody Test detects what antibodies might be present in the blood at the moment of testing, so one can take action according to the stage of infection one might be in.
Combined, the two tests can be used to achieve full coverage testing by showing the presence of an active COVID-19 infection in the body and the presence of antibodies in the blood. In this way the virus’s activity in the body can be detected and followed. In addition, the COVID-19 Antigen Test Pen can confirm the presence of an active infection, or lack thereof, in the body at the moment of testing.
- Test time: 15 minutes
- Storage: Store at 2~30℃ when not in use.
- Shelf life: Kit contents are stable until the expiration dates marked on their outer packaging and containers.
- Individually packed Saliva Collector with Test Strip
- Individually packed Extraction Buffer
- Package inserts
Materials Required but Not Provided:
- Clock, timer, or stopwatch
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C), and another band appears in the test region (T).
NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.