Covid-19 disease is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
An immunoglobulin test measures the level of types of antibodies in the blood. The immune systems makes antibodies to protect the body from bacteria, virus and allergens.
Immunoglobulin M (IgM): Found mainly in blood and lymph fluid, this is the first antibody the body makes when it fights a new infection.
Immunoglobulin G (IgG): This is the most common antibody. It’s in blood and other body fluids, and protects against bacterial and viral infections. IgG can take time to form after an infection or vaccine.
This is the the relative timing of IgM and IgG production in the body when exposed to the Covid-19 virus.
Covid-19 Rapid Test IgM Kit: The kit has everything you need to perform the test: alcohol swab to clean the tip of your finger, the lancet to prick your finger, the pipette to collect the blood from your finger prick, the testing cassette, and the reagent needed. The test is ready to be read and give you results in 11 minutes. This test is for IgM detection, the red line on the graph. Click here to order this test for IgM. Ships within 24 business hours. Extremely limited supplies.
Covid-19 Rapid Test IgG Kit: The kit has everything you need to perform the test: alcohol swab to clean the tip of your finger, the lancet to prick your finger, the pipette to collect the blood from your finger prick, the testing cassette, and the reagent needed. The test is ready to be read and give you results in 11 minutes. This test is for IgG detection, the green line on the graph. Click here to order this test for IgG. Ships within 24 business hours. Extremely limited supplies.
Covid-19 Rapid Test for IgM and IgG kits: click here to order both kits.
The United States (U.S.) FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19. An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD.
What does it mean if the specimen tests positive for IgM and/or IgG antibodies against virus that causes COVID-19? A positive test result with the qSARS-CoV-2 IgG/IgM Rapid Test indicates that antibodies to SARS-CoV-2 were detected, and the patient has potentially been exposed to COVID-19. When IgM antibodies are present, they can indicate that a patient has an active or recent infection with SARS-CoV-2. It is unknown how long IgM or IgG antibodies to SARS-CoV-2 will remain present in the body after infection and if they confer immunity to infection.
What does it mean if the specimen tests negative for IgM and/or IgG antibodies against virus that causes COVID-19? A negative test result with this test means that SARS-CoV-2 specific antibodies were not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment, patient management decisions, or to rule out active infection. Patients tested early after infection may not have detectable IgM antibody despite active infection; in addition, not all patients will develop a detectable IgM and/or IgG response to SARS-CoV-2 infection. The absolute sensitivity of the qSARS-CoV-2 IgG/IgM Rapid test is unknown.
