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.
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
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.
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.
Early infections may not have generated sufficient antibodies to be positive on the test
Currently it is not known if having any IGG antibodies indicates immunity; however, having IGG antibodies does indicate having had the infection.
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.
There is a 13% false negative rate (Out of 100 people with the disease up to 13 may falsely test negative).