The COVID 19 IgG/IgM Antibody Test
The COVID 19 IgG/IgM antibody test is a 15 minute instant point of care test device for the qualitative detection of IgG and IgM antibodies specific to 2019 nCoV in human whole blood performed by a finger prick. Patients who test positive or have symptoms may also be referred for a PCR test.
COVID 19 Antibody Testing
The test being offered is a blood test that checks for SARS CoV 2 virus antibodies. This test checks for IGM and IGG antibodies. An antibody test checks for your body’s response to a virus, not the virus itself.
A negative test does not mean you do not have SARS CoV 2 as it may take several days for your body to make antibodies against the virus.
A positive test may indicate, you either have SARS CoV 2 or are recovering from it. A positive IGG test does not mean you are immune.
Testing Limitations
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This test has not been reviewed by the FDA but is being offered under the FDA’s Policy for Diagnostic Tests for Coronavirus Disease 2019, Section IV.D
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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.
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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.
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Early infections may not have generated sufficient antibodies to be positive on the test
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Currently it is not known if having any IGG antibodies indicates immunity; however, having IGG antibodies does indicate having had the infection.
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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.
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There is a 13% false negative rate (Out of 100 people with the disease up to 13 may falsely test negative).
