COVID-19 Antibody Testing
We are proud to offer COVID-19 Antibody Testing, in addition to COVID-19 Virus Testing, through the direction of our state-of-the-art Urgent Care facility in Temecula. Please important information below regarding the COVID-19 Antibody Test.
COVID-19 Patient Guide
Listen to the COVID-19 Podcast
The Valley News is featuring Dr. James W. Rhee, UMD Urgent Care Medical Director on their Newsmakers Podcast in a weekly COVID-19 series. Listen to weekly updates from Dr. Rhee below!
What COVID-19 Antibody Testing Is
The COVID-19 Antibody Test is a blood test that identifies the IgM and IgG antibodies that are specific for COVID-19. We expect that it will only require blood from a fingerstick (i.e., similar to the test for diabetic patients to test their blood sugar levels). These antibodies are produced by the body in response to infection and can start to appear soon after infection.
The IgM antibody is produced during the acute phase of antibody production. The IgG antibody develops in the body soon after infection as well, but typically lasts in the body for a much longer period of time. The presence of IgM and/or IgG would indicate that the body was exposed to the virus and the body has responded with the production of these antibodies. The detection of IgG can potentially mean that the body has developed immunity against further infections by the same virus.
How You Can Get The Test
At United Medical Doctors Urgent Care, we want to ensure that we are delivering high-quality care to our patients and community. As such, we feel strongly that if you have concerns that you may have COVID-19 because of your symptoms or because of exposure, we want to evaluate you as a patient first. As each individual is unique and the interpretation of diagnostic tests should be done in the context of other factors, a medical evaluation is an important part of any diagnostic evaluation. This evaluation may be performed through our Telemedicine platform that can be accessed through our United MD Mobile App. To schedule a Telemedicine visit and for more information on utilizing the United MD App for a Telemedicine visit, please call United Medical Doctors Urgent Care at (951) 383-2618.
If through our evaluation we feel that antibody testing is needed, we would direct you to drive to our United Medical Doctors Lab located in Murrieta. This lab is CLIA-licensed to perform high complexity tests in accordance with guidance from the FDA. Here, your blood will be collected by a fingerstick. Once the test is run, we will call you with the result and help you understand what it means. The results should be available on the same day.
Patient Criteria Guide
There are numerous criterion that our providers take into account when evaluating each patient. Those items include but are not limited to: flu-like symptoms (cough, shortness of breath, fever, body aches, headache), COVID-19 exposure, or recent travel within 30 days. Below is a patient criteria graphic to use as an informational guide to aide in determining which patients are ideal candidates for the COVID-19 Antibody Test.
Why This Test Was Not Available Before
While COVID-19 Antibody Testing has not been available in the United States, it has been used in other countries across the world as part of their response to managing the COVID-19 pandemic. Notably, antibody testing has been widely used in Singapore, Taiwan, and South Korea as a component of their public health strategy.
Recently, the FDA has allowed antibody testing for COVID-19 to become available in the United States.
In an effort to provide this service to our patients, we have been able to acquire SD Biosensor’s Standard Q COVID-19 IgM/IgG Rapid Tests. These are the same tests that were deployed in South Korea as part of their response to the current COVID-19 pandemic. As such, we have a great deal of confidence in this test. To view more about the test itself, visit SD Biosensor’s website here.
However, at this time, this test is not FDA-approved or reviewed. A number of caveats need to be expressed about this test:
- 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.
While the FDA is allowing the distribution of this test to occur under its enforcement discretion, they have indicated that this test should not be performed outside of a CLIA-licensed facility with the ability to do high complexity tests. In other words, these tests cannot be performed in most medical office settings unless it has a CLIA-licensed lab.
Given the number of COVID-19 Antibody Tests that are being developed and distributed across the country by multiple manufacturers, it makes sense for the FDA to give this guidance at this time to ensure that these tests are conducted in environments to maintain quality and integrity.
Unfortunately, we have seen recently in the United Kingdom that there have already been a number of invalid COVID-19 Antibody Tests being sold. We have also seen some antibody tests being marketed online with inaccurate statements. While we are advocates for greater access to testing, we do have some concerns about the validity of the tests given the experience in the United Kingdom.
Over the past month at United Medical Doctors Urgent Care, we have reviewed the performance of Standard Q COVID-19 IgM/IgG Rapid Test in South Korea and feel that it has been thoroughly validated. We are also fortunate that our parent company, United Medical Doctors, has a lab that is CLIA-licensed to perform high complexity testing and can internally validate these tests. However, in order to ensure integrity, we strongly feel at this time that we also need to interpret the test with a greater clinical picture. In other words, we will not rely on just this test to make any definitive diagnoses. We will only use the test result in the context of the patient.
Additional Tests That Can Be Done
While this antibody test may be helpful in many situations, it may not always be the most appropriate test to use to assess an individual patient’s illness. We have access to multiple other tests that may help in the setting of COVID-19 symptoms.
This includes access to testing for multiple other pathogens through our BioFire Respiratory EZ Panel. This test is located in our Urgent Care facility and can identify up to 14 different respiratory viral and bacterial pathogens. The identification of another pathogen that causes symptoms similar to COVID-19 can help establish an alternative diagnosis. The results from this test are available on the same day.
Since it may take a few days for antibodies to develop, and if you have symptoms that have just started, we may want to test you directly for the COVID-19 virus (as opposed to the antibodies to the virus) through the collection of a specimen from your nose. We would subsequently send this specimen to a reference laboratory that can check for genetic material specific for the COVID-19 virus. The results from this test usually come back in 2 to 3 days.