What Test is Used by The Laboratory?

Our laboratory partner will test your blood sample using a SARS-CoV-2 IgG immunoassay test with a Sensitivity of over 90%.

The SARS-CoV-2 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgG antibodies to SARS-CoV-2 in serum. 

Unlike rapid tests with mostly a low sensitivity and accuracy, an immunoassay test has over 90% Sensitivity and a Specificity of 99-100% according to our laboratory partner, making it one of the most accurate antibody tests on the market.

How do Antibodies Develop?

An infection with COVID-19 is followed by an incubation period of up to 14 days.

The incubation period is followed by the active phase for up to 21 days during which you may or may not show symptoms.

Around 7 days after the end of the incubation phase, most humans typically start slowly building IgG antibodies to fight off the infection. 

A positive result for IgG antibodies may suggest an immune response to a primary infection with SARS-CoV-2, but the relationship between IgG positivity and immunity has not yet been firmly established.

It also has yet to be determined how long IgG antibodies are able to be found in your blood and how quickly the Antibody levels decrease over time. It is not known for certain whether individuals infected with SARS–CoV-2 who subsequently recover will be protected, either fully or partially, from future infection with SARS–CoV-2 or how long protective immunity may last.

Limitations of The Tests

  1. This test has not been reviewed by the FDA.
  2. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  3. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  4. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  5. Immunoassay tests were released for diagnostic use under the Food and Drug Administration (FDA) guidance “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers and Food and Drug Administration Staff” originally issued on February 29, 2020, and updated on March 16, 2020.
  6. Not for screening of donated blood.
  7. The test we offer is not intended to diagnose or treat disease. This test is not intended to be a substitute for seeking professional medical advice, help, diagnosis, or treatment. If you are experiencing active symptoms of potential COVID-19 such as fever and difficulty breathing, seek medical attention right away.

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