The GenaCheck COVlD-19 Rapid Self-Test is a visually read lateral flow immunoassay test intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVlD-19.
This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment.
Positive results do not rule out co-infection with other respiratory pathogens.
This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. lindividuals who test negative and experience continued or worsening COViD-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.
The performance characteristics for SARS-CoV-2 were established from March 2024 to October 2024 when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspect.
The test is Positive if:
There are two colored lines.
There are two colored lines, even if the color of the line next to the T is Faint. Look Closely!
You do not need to perform repeat testing if youhave a positive result at any time.
A positive test result means that the virus that causes COVID-19 was detected in your sample.
Note: Any faint visible pink color test (T) line should be interpreted as positive, when the Control (C) line is also present. The Test (T) line may vary in shade and intensity (light or dark, weak or strong) depending on the concentration of antigen present in the sample. The intensity of the Control (C) line should not be compared to that of the Test (T) line for interpretation of the test result.
If the Control (C)line is visible, but the Test (T) line is not visible, the test is negative.
A negative test result indicates that the virus that causes COVID-19 was not detected in your sample. Repeat testing is needed to improve test accuracy, If your first test result is negative, you must repeat testing (serial testing) with another test between 24 and 48 hours later, however negative results do not rule out infection.
If no line appears in the Control (C) area, the test results are invalid regardless of the presence or absence of a line in the Test (T) area. An invalid result means the test was not able to tell if you have COVID-19 or not. If the test is invalid, re-test with a new swab and new test device.
