EDITOR’S NOTE: Emergency medicine expert, microbiologist and retired clinician Dr. Charles Patrick Davis, MD, PhD; sits on MedicineNet’s editorial board. His COVID-19 action plan outlined in his opinion piece below comes March 30, 2020, just days after the FDA approved a 5- to 15-minute ID NOW COVID-19 testing kit from manufacturer Abbott. The day this article published, the FDA announced in a release its steps to streamline approval processes for newly developed coronavirus tests. The FDA has worked with 230 different labs developing new tests, approving 20 of those for use in diagnosing COVID-19 to-date, the release states.
We can do better at testing for COVID-19 Coronavirus
While watching New York healthcare workers struggle under the exhausting and heartbreaking burden of COVID-19 patients, I couldn’t help planning a better testing and diagnostic system than the haphazard one authorities seem to be following currently.
The shortage of COVID-19 test kits has not only hindered efforts to stop the spread of the virus, but also keeps workers who are immune and don’t know it stuck at home, often out of the workforce. However, this test kit shortage will end soon (about one to two weeks)
Despite the fact they may have a reduced chance of catching the virus, untested people who have had the SARS-CoV-2 virus that causes COVID-19 with little or no symptoms and recovered are under the same quarantine as everyone else.
Many of them could go back to work.
Eighty percent of people with COVID-19 recover without hospital or doctor care and are not likely to be infected again; the body typically becomes immune to these types of viruses after a single infection. We could get those 80% of healthcare workers and volunteers, as well as workers in general, back in their hospitals, offices and job sites if we could just institute rapid COVID-19 testing on a large scale.
What is the goal of mass COVID-19 testing?
The goals of mass testing are to accurately test most people to determine their status in relation to this infectious disease so they can go forward with their lives.
The large majority of people fall into the categories below:
- People that have COVID-19, (with or without symptoms),
- Some results may also show whether or not the infected patient's immune system seems to be responding well or poorly to the virus
- People not yet exposed to the virus,
- People that have immunologically responded and have a good antibody response (and possibly be an antibody donor to help fight the virus in other people),
- People able to go back to work and be unaffected by the virus and currently not transmitting the virus, even if they were positive for the virus at some point in the past.
How can healthcare workers meet COVID-19 testing demand?
Healthcare workers may increase COVID-19 testing to meet demand by using newly available tests that can determine the presence or absence of SARS-CoV-2 shedding, along with the detection of antibodies specific for the virus. Abbott Laboratories, for example, just got their new test kit FDA-approved in the last few days.
Here's how a standardized public testing regimen could work:
- Utilize the new Abbott ID NOW Covid-19 test (FDA approved) in tandem with the BioMedomics test FDA approved for use in this pandemic;
- Abbott tests for COVID-19 genome segments, while BioMedomics tests for IgM and IgG antibodies specific for COVID-19 antigens.
- Both tests are fast, portable, small, self-contained, point-of-care tests that can be done by almost anyone, including trained volunteers.
- A patient has a swab done for the Abbott genome test and a drop of blood taken for antigen detection in the BioMedomics test.
- The samples are put into point-of-care devices that detect the viral genetic material or antibodies
Both tests are easily portable, work at room temperature, and give results in about 15 minutes!
What do the different test results for COVID-19 coronavirus mean?
These tests tell you about a person’s exposure and response to the COVID-19 coronavirus, or tell you whether you are infected; both tests, when run in tandem, give accurate, specific answers about a person’s status:
- Abbot: Learn if a patient has detectable virus or no detectable virus genome in fifteen minutes
- This test tells you whether or not you're infected.
- BioMedomics: Learn if a person either has no detectable antibodies, has IgM antibodies, has both IgM and IgG antibodies, or only IgG antibodies to COVID-19 virus antigens in fifteen minutes.
- This test shows if a person has been exposed to the virus, but not whether they are still infected.
The results of these two different COVID-19 tests, run in tandem, can determine the person’s status as described below:
- A positive Abbott test means the person is actively shedding virus and is contagious;
- A negative test means the person is not shedding virus;
- With two negative tests done 24 hours apart, according to CDC, the person is not contagious (shedding virus), meaning the person either has never been infected or (if previously infected) is no longer shedding virus.
- If BioMedomics tests are all negative, the test indicates the person has not been recently exposed to the COVID-19 virus.
- If the test shows only IgM, the person is likely in the early stage of the virus infection;
- If IgM and IgG are positive, the person is likely in the middle stage of infection,
- If the person is only positive for IgG, then the person is either over the infection or in its last stage.
If you get negative COVID-19 test results, it means one of the following results about your status:
- Negative tests from both test kits means the person likely has not been exposed to the virus and is still at risk
- (negative test of BioMedomics needs a negative gene test confirmation; that occurs when these two tests are run in tandem).
- Any positive tests from either test indicates that the person is infected
- (or recently infected and recovered with a positive IgG only test).
- If one test shows a negative result and the other tandem test shows a positive test, then the tests should be rerun.
- Two negative Abbott tests in 24 hours and a positive test for IgM and IgG indicate the patient is recovering and not shedding virus;
- The same is true for a positive IgG test.
People with two negative Abbott tests and a positive IgG test have likely become immune to the virus and can go back to work without fear of spreading or becoming reinfected. This could begin economic recovery as about 80% of people infected recover.
Also, these people could become potential serum donors for IgG that could be used to treat people having difficulty recovering from COVID-19 infection.
The tandem use of both tests on a person can reach the goals stated above in 15 minutes except for the question of shedding virus that takes two tests on Abbott’s kit 24 hours apart. The tests cited here are not the only available tests. Also, there may be other ways to use the data to help solve patient-related problems.
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BioMedomics IgM, IgG