What happens if I test COVID-19 negative, but I was very symptomatic a few weeks ago?

A negative COVID-19 IgG/IgM Rapid Test result does not rule out SARS-CoV-2 virus infection, particularly in those whom have been in contact with the virus.  Follow-up testing via CDC and/or FDA approved molecular diagnostic specifically for SARS-CoV-2 should be considered to rule out infection of SARS-CoV-2.

What if I test COVID-19 positive, but have no symptoms?

A positive result from the COVID-19 IgG/IgM Rapid Test indicates that anti-SARS-Cov-2 IgG, IgM, or both were detected in the patient’s specimen.  Confirmation of COVID-19 IgG/IgM Rapid Test requires additional testing by CDC or by qualified laboratories designated by CDC and in consultation with CDC, and/or other FDA approved molecular SARS-CoV-2 tests.

Positive COVID-19 IgG/IgM Rapid Test results are not definitive for diagnosis of SARS-CoV-2 virus infection and must be confirmed with additional molecular testing and/or consideration using the latest CDC and/or FDA approved SARS-CoV-2 testing.

What if the test is IgM positive?

In general Immunology, IgM serves as the first kind of defense, which means it is the first antibody to be immediately developed when any foreign particle is introduced, though its function is temporary.

The positive test result for IgM does not confirm that you have an active SARS-CoV-2.   Confirmation of COVID-19 IgG/IgM Rapid Test requires additional testing by CDC or by qualified laboratories designated by CDC and in consultation with CDC, and/or other FDA approved molecular SARS-CoV-2 tests.

What if the test is IgG positive?

In general Immunology, IgG is a long-term response for any disease and thus protect our body from viral and bacterial attacks.

Confirmation of COVID-19 IgG/IgM Rapid Test requires additional testing by CDC or by qualified laboratories designated by CDC and in consultation with CDC, and/or other FDA approved molecular SARS-CoV-2 tests.

How long after exposure to the SARS-CoV-2 virus would the test be able to detect antibodies?

It could take up to 8 – 11 days after exposure to the virus to have detectable IgM antibodies for SARS-CoV-2.

What is the significance of the various test results?​

IgM negative, IgG negative: Patient not exposed or too early. A medical professional should observe symptoms and epidemiology of patients. Retesting should be considered if symptoms appear or persist.

IgM positive, IgG positive/negative: Acute or recent infection.

IgM negative, IgG positive: Previous, distant infection.

How long after initial infection will the COVID-19 test detect antibodies?

At this point, there is still much that is unknown about the serological aspects of this 2019 novel coronavirus (SARS-CoV-2).  However, there is serological data from the 2002 SARS outbreak (SARS CoV) that shows detectable IgG antibodies 60 days after initial symptom onset. (Chen X et al. J Infect Dis. 2004;189(7):1158-63)

I want to donate blood, but also want to know if I have COVID-19 infection.  What do I do?

The COVID-19 IgG/IgM Rapid Test Cassette is NOT for the screening of donated blood.

Are there any additional procedural instructions other than what is in the Instructions for Use?

The test protocol in the Instructions for Use is the best and only available instructions for the COVID-19 IgG/IgM Rapid Test Cassette.

What is the HCPCS Code?

The U0002 is the HCPCS code.

Is there a CONTROL for the test?

There is an internal control line in the test cassette to assure proper protocol operation.

Can I have help interpreting this test?

Aytu cannot interpret test results.  If you are unsure of the test result, it is recommended that the test procedure is repeated.  Please be sure to follow the test protocol carefully, also be sure not to overfill the specimen well (S).