RapidGo™ Flu A/B and COVID-19 Home Test

For in vitro diagnostic use

For Over-the-Counter Use

 

The RapidGo™ Flu A/B and COVID-19 Home 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 symptoms of COVID-19 and influenza. Clinical signs
and symptoms of respiratory viral infection 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, if necessary for patient management. Negative results do not rule out infection with
influenza, SARS-CoV-2 or other pathogens.

This test is not a substitute for visits to a healthcare provider and should not be used to determine any treatments without consulting with a healthcare provider. Individuals who test negative
and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens.

The RapidGo™ Flu A/B and COVID-19 Home Test is intended 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

  • Key Benefits
    Detect 3 viruses are once (SARS-CoV-2, Flu A&B)
    For symptomatic individuals within 5 days of symptom onset
    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.
Interpreting Your Results

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.