GenaCheck® COVID-19/Flu A&B Rapid Self-Test

GenaCheck® COVID-19/Flu A&B Rapid Self-Test

For in vitro diagnostic use

For Over-the-Counter Use

The GenaCheck® COVID-19/Flu A&B Rapid Self-Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. 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 and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza and SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should therefore seek follow-up care from their healthcare provider.


Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.


The clinical performance of this test was established based on the evaluation of a limited number of clinical specimens collected between February 2024 through April 2024. The clinical performance has not been established for all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. There is a risk of false negative results due to the presence of novel, emerging respiratory virus variants. Test accuracy may change as new virus variants of COVID-19 and influenza emerge.


Key Benefits

• Simultaneously detect 3 viruses (SARS-CoV-2, Flu A&B)
• No repeat testing necessary (compare to EUA kits)
• Two result windows for easy readability
• Shallow nasal swab sample collection
• Suitable for 2+ years old

* Swabbing should be performed by an adult for children aged 2 to 13. User must be aged 14 + to perform self test.


Specifications

• Specimen: Nasal Swab
• Time to Results: 15 minutes
• Stability: 18 months
• Storage: 36-86°F (2-30°C)

Quick Reference Instructions  

Interpreting the Results

Additional Resources  

Frequantly Asked Questions

Quick Reference Instructions
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Dowloadn the QRI
Interpreting Your Results

C = Control line

Flu B = Flu B line

Flu A = Flu A line

COVID = COVID-19 line

Look for lines next to “C” (Control) Flu B, Flu A and COVID.

Check to see if a line is visible at the Control Line labeled “C” on the device.

Look Closely! Any faint line is still a line.

POSITIVE TEST RESULT
Both ‘C’ lines must be PRESENT
Consult your healthcare provider to discuss your positive test result. Self-isolate at home per CDC recommendations to stop spreading virus to others.
NEGATIVE TEST RESULT
Both ‘C’ lines only
If you do not see a line at ‘COVID’, ‘Flu A’ or ‘Flu B’, it means you may not have COVID-19 Flu A or Flu B virus. If you still have COVID-19, Flu A or Flu B symptoms, you should seek follow up care with your healthcare provider.
INVALID TEST RESULT
Missing ‘C’ line on ONE or BOTH strips
Check to see if a line is visible at the control line ‘C’ on both strips. If you do not see any C line, or only see one C line, DO NOT CONTINUE reading the results. It means your test is invalid. Repeat the test with a new sample and new test kit materials.
Frequantly Asked Questions

 

A: If the control line (C) is not visible on both test strips, the test is invalid, even if any test line is visible. An invalid test result means that the test is unable to determine if you are infected with influenza or SARS-CoV-2 (COVID-19) or not. The test needs to be repeated with a new kit and sample.

 

A: A negative test result means that COVID-19, Flu A, and/or Flu B viruses were not detected in the sample. A negative result is presumptive because despite a negative result you may still have COVID-19, Flu A, and/or Flu B infection. This is because the amount of virus in your sample may be too low for the test to detect it, which is called a ‘false negative result’. False negative results can occur if you read your test result before the 15 minutes have passed or when your sample has only a low amount of virus in it. Low amount of virus can occur if you take your sample at a time when your symptoms just started appearing, or when you already started to feel better at the end of your infection. There is a higher chance of false negative results with antigen tests compared to laboratory - based molecular tests. If you tested negative and continue to experience COVID-19, Flu A, and/or Flu B-like symptoms, you should therefore seek follow-up care with your healthcare provider who will determine the best course of action. Your healthcare provider can also determine if confirmation of your test result with a molecular assay is necessary.

A: A positive test result means that any one, or multiple, of the viruses detected by this test were also detected in your sample. It is very likely that you have the respective COVID-19 or influenza infection(s) and are contagious. You should self-isolate following local guidelines. Please contact your physician or healthcare provider to discuss your test results and follow-up care. In rare instances, individuals may also have co-infections with other bacteria or viruses that this test is not designed to detect. This means that the virus detected by this test may not be the definitive or the only cause of your disease. There is a very small chance that this test or influenza infection can give you a positive result that is incorrect (a false positive).

A: If uncertain how to proceed, contact Technical Assistance at [email protected] or 1 - 800 - 614 - 3365 (9:00-17:00 Eastern Time).

A: Report your test result(s) at MakeMyTestCount.org - This voluntary and anonymous reporting helps public health teams understand COVID-19 spread in your area and across the country and informs public health decisions. Securely report your GenaCheck® COVID-19/Flu A&B Rapid Self-Test result to public health teams by visiting: https://www.makemytestcount.org/genabiodiagnostics

A: There are different kinds of tests for the viruses that cause COVID-19 and the flu. Molecular tests detect genetic material from the virus. Antigen tests, such as the GenaCheck® COVID-19/Flu A&B Rapid Self-Test, detect proteins from the virus. Due to the lower sensitivity of antigen tests, there is a higher chance this test may give you a false negative result.

A: The GenaCheck® COVID-19/Flu A&B Rapid Self-Test was compared to an FDA-authorized known high sensitivity SARS-CoV-2 PCR test and an FDA-cleared known high sensitivity Influenza A and B PCR test. For more information on the performance of the test and how the performance may apply to you, please refer to the performance data in the Healthcare Provider Instructions for Use (IFU), available at https://www.genabio.com/COVID-19-flu-a-b