Intended use
The Rapid SARS-CoV-2 Antigen Test Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.This test is authorized for non-prescription home use with self- collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individual aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.
The Rapid SARS-CoV-2 Antigen Test Card does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in
anterior nasal (nares) swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not
be the definite cause of disease. Individuals who test positive with the Rapid COVID-19 Antigen Test Card should self- isolate and seek follow up care with their physician or healthcare provider as additional testing may be necessary.
All negative results should be treated as presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks.
The Rapid SARS-CoV-2 Antigen Test Card is authorized for non-prescription self-use and/or as applicable an adult lay user testing another person 2 years or older in a non-laboratory setting.
The Rapid SARS-CoV-2 Antigen Test Card is only for use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved.
How to Use
Slowly rotate the swab in a circular motion 5 times by firmly pressing against the inside walls of the nostril for a total of 15 seconds. Do not just spin the swab. Gently remove the swab and repeat in the other nostril using the same swab.
Place the swab into the buffer tube. Rotate the swab 5 times. Set a timer and leave the swab in the buffer tube for 1 minute. Pinch the buffer tube with your fingers and remove the solution from the swab as much as possible.
Invert the buffer tube and add 3 drops of the test sample into the sample well (S) by gently squeezing the extraction tube. Do not add the test sample to the rectangular results window.
Reading the Results
Negative Result
If the Control (C) line is visible, but the Test (T)line is not visible, the test is negative.
Positive Result
If a Control (C) line and the Test (T) line are visible, the test is positive. Any faint visible pink/purple test (T) line with the control line (C) should be read as positive.
Invalid Result
If a control line (C) is not visible, even if the test line is visible, the result must be considered invalid.
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