Until now, testing for Coronavirus Disease (COVID-19) required collecting a sample and testing that sample for the presence of COVID-19 viral RNA. This testing is invasive. It requires a deep nasopharyngeal swab performed by a health care provider wearing personal protective equipment, and sending the sample to a lab for analysis. Unfortunately, during this pandemic, the availability of testing has been limited, the turnaround time lengthy (two to seven days or more), and PPE to protect health care workers is in short supply.
There is good news: a new test — an antibody test — is now available in the US to detect the presence of antibodies to COVID-19. This test does not detect viral RNA but instead detects the body’s antibody response to the virus.
On March 16, the U.S. federal government took an unprecedented step to accelerate availability of testing for COVID-19 during this national crisis. The US government has fast-tracked access to COVID-19 testing by allowing developers of testing to commercialize products in the U.S. without a requirement for FDA approval or Emergency Use Authorization, as long as specific criteria are met.
Consistent with FDA guidance, Premier Biotech (premierbiotech.com) has made available a rapid test produced and widely used in China during the pandemic, that detects the presence of antibodies to COVID-19*. This test detects IgG (past infection) and IgM (acute infection) antibodies — the antibodies that your body makes to fight off the COVID-19 virus. The simple finger stick blood test to detect these antibodies will determine whether a person has been infected by COVID-19, and results are provided within ten minutes.
Healthcare workers and those who live with healthcare workers
Other individuals on the front lines including police, fire, EMT, and other individuals likely to be exposed
If you are currently sick and have not yet been tested. Although not a perfect test, the rapid test may show if your body is producing the specific IgM antibodies that develop quickly (within about seven days) after exposure to COVID-19. However, a negative test result does not mean you don’t currently have COVID-19. It could mean that you have not been infected long enough for your body to begin producing antibodies.
Anyone over the age of 16 who wants to know if they have had COVID-19 already (either symptomatic or asymptomatic). For example, if you had symptoms prior to testing capabilities, or if you know you have been exposed to someone who is or was sick with COVID-19.
The first test is free for members of Laurie Birkholz, MD, and Associates, and $75 per test for non-members / $40 if a healthcare worker of first responder (while supplies last.)
We believe in evidence-based medicine and are aware that this test, while FDA-authorized, has not yet been FDA approved. However, because the presence (or lack of) COVID-19 antibodies provides valuable information for so many of us, we feel in this situation we should provide early access to this type of test. This test has been widely used in other parts of the world and studies have demonstrated its validity, and it is currently under review for Emergency Use Authorization with the FDA. As more testing becomes available, we will evaluate the best choices for our patients, and we may advise repeat testing for certain individuals. Our priority is to keep our patients healthy, and we believe antibody testing is one way to arm our patients with valuable information to help them stay well.
This test has not been reviewed by the FDA
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.
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.