We now have onsite point of care rapid testing for COVID-19 antibodies, to detect both IgM and IgG antibodies. I have chosen an American company that manufactures its own on-site testing products in the United States, and that confirms results at the highest certification levels.
If you are interested in being tested for the antibodies to COVID-19, you must be symptom free for a minimum of 14 days before we will test in the office. If you have symptoms and you feel you might have active COVID-19 we can refer you for testing to Beebe drive through testing sites.
This test measures human SARS-CoV-2 antibodies, IgM and IgG that are generated as part of the human immune response to the virus and is to be performed using serum, plasma, or venipuncture whole blood specimens collected from individuals suspected of COVID-19.
WHAT IS THE INTENDED USE FOR THE COVID19AbRAPID TEST?
- To identify presumptive positive COVID-19 cases;
- To screen for negative COVID-19 cases
- To determine if a person has been infected with SARS-CoV-2 in the past and has developed immunity.
- If COVID-19 antibodies are found to be present, you may be eligible to donate convalescent plasma to the Delmarva Blood Bank.
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 SARSCoV-2. IgG antibodies develop later following infection, and generally do not begin to appear until 7 – 10 days after infection. When IgG antibodies are present it, often indicates a past infection but does not exclude recently infected patients who are still contagious, especially if detected with IgM antibodies. 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.
Is this test FDA approved?
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.
If you would like to be tested for the presence of antibodies to the virus that causes COVID-19 or if you have questions about this testing, please email us at info@renovemedspa.org. We will test one patient at a time to limit possible exposures.
Sensitivity and Specificity
IgG Result
Relative Sensitivity: 100%
Relative Specificity: 98.0%
Accuracy: 98.6%
IgM Result
Relative Sensitivity: 85.0%
Relative Specificity: 96.0%
Accuracy: 92.9%
