Update on COVID-19 (Coronavirus):
Below is a guide to assist patients with possible Coronavirus (COVID-19) Symptoms:
” COVID-19: Antibody testing FAQs for providers. What you need to know:
Q: What is an antibody test, and should patients get one?
A: The antibody test looks for IgG antibodies in the blood produced in response to SARS-CoV-2. We are still learning more information about the best use of these tests. Currently, antibody tests do not help us provide any information about current infection status, immunity or one’s risk of getting the virus in the future and can only provide information about whether someone has been infected in the past.
Q: What are some of the speciﬁc issues related to the tests?
A: The vast majority of the tests available lack the sensitivity and speciﬁcity to safely distinguish antibodies to COVID-19 (SARS-CoV-2) from antibodies to other common coronaviruses. UCHealth has developed the ability to perform serology testing for antibodies to COVID-19 (SARS-CoV-2) with >97% speciﬁcity.
Q: Does a positive antibody test mean that someone is immune?
A: No. The antibody response in infected patients remains largely unknown, and there are different antibody tests with variable performance. According to the World Health Organization (WHO) there is currently not enough evidence to suggest that people who have recovered from COVID-19 and have antibodies are protected from a second COVID-19 infection.
Q: What commercial antibody tests are available?
A: There are a variety of different antibody tests out there, ranging from ﬁngerstick tests to more comprehensive enzyme-linked immunosorbent assay (ELISA) serum tests that require a blood draw. UCHealth is currently utilizing (ELISA) serum tests that require a blood draw only. UCHealth is currently using both the Abbott and DiaSorin tests and is completing validation on a third ELISA test. At this time, we do not believe there is a rapid (ﬁnger prick) test available which is sufﬁciently sensitive or speciﬁc. We emphasize that although the Abbott and DiaSorin tests are very good at detecting SARS-CoV-2 IgG antibodies, results are not being used to determine immunity or active infection, only prevalence in the community (number of people with past infection).
Q: Are the Abbott and DiaSorin tests being used by UCHealth approved by the FDA?
A: Yes. Both of these tests have been evaluated by the FDA and meet the agency’s accuracy requirements. These are among the few antibody tests authorized by the FDA.
UCHealth is actively monitoring current data and national and international recommendations on the accuracy and utility of COVID-19 antibody tests as the demand for the test increases within our community. Based on the current evidence, UCHealth is following recommendations from organizations such as the Centers for Disease Control, World Health Organization and the Infectious Diseases Society of America and does not recommend rapid antibody testing at this time for diagnostic decisions or assessments of immunity. While the tests can help us better understand the level of SARS-CoV-2 (the virus that causes COVID-19) exposure in the community (prevalence), they are not useful in guiding clinical decisions (i.e. whether a patient is immune or has an active infection).
The following document has been developed to assist UCHealth providers navigate frequently asked questions regarding antibody testing and deciding for which patients SARS-CoV-2 antibody tests should be obtained.
Jan Gillespie, MD”
Our providers at MVFP are in close contact with many of the leaders of the nationwide COVID-19 response team. We are continuously getting questions related to the anti-body tests for COVID-19, and we are doing our best to keep our community and patients as up to date as possible. Above is a recent FAQ presented to us by Jan Gillespie and conducted by UCHealth. The highlighted sections above will be the most relevant to you, but please feel free to look into and ask us about the other Q & A’s. MVFP is following antibody testing very closely. We do not recommend antibody testing for COVID yet. We see the primary goal of the test is to answer either; were we infected and/or are we immune from getting infected. Currently, antibody testing cannot answer either question. If we have a positive antibody level the likelihood the test is falsely positive is more likely than a true positive. This means the test is wrong more times than it is correct. The test does not help us know if you had been infected with COVID or not. This means we cannot tell you that you will not get infected in the future.
Stay cautious and safe, protect yourself and others in closed spaces.
The New York Times (5/4, Kaplan) reports the FDA “announced on Monday that companies selling coronavirus antibody tests must submit data proving accuracy within the next 10 days or face removal from the market.” While the tests aim to determine whether a person has been previously infected by the coronavirus, there has been widespread variation in results, and “since mid-March, the agency has permitted dozens of manufacturers to sell the tests without providing evidence that they are accurate.”
This means: Blood antibody tests that we all read about are NOT that good at telling us if we have been infected with COVID. As a result of the hype around the ‘anti-bodies’ against COVID-19, people are starting to ignore the recommendations of wearing a mask in public, social distancing, amongst others. The FDA, AMA, and AP, are all recommending physicians to limit their use of antibody tests. This is in direct correlation to the unknowns of the antibody tests, these tests are still very new and very unreliable. When someone tests positive for any test (anti-body/ other), that does NOT mean that they have had COVID-19, again these tests are very untrustworthy. PLEASE DO NOT RELY ON ANTIBODY TESTS TO GUIDE YOUR DAILY ACTIVITIES SURROUNDING YOUR PROTECTION FROM COVID-19.