We are still far from the development of an organized, rational lab testing strategy for COVID-19 sat the national level. Whatever plan that exists today is marked by a lack of federal coordination and divisive political messaging. This mix of confusion and contradictory messages continues with the two major for-profit national reference labs, Quest and LabCorp, now offering COVID-19 antibody testing directly to consumers (see: Quest's new service lets customers request COVID-19 antibody test). Below are the details:
Quest Diagnostics announced that it will be offering a “consumer initiated” COVID-19 antibody test for $119. Dubbed Quest Direct, the service will let consumers request the antibody test through an online platform. Once the request is initiated it is sent to a licensed physician, who greenlights the testing order. Patients can then go to a Quest service center to get their blood drawn, and get results within one to two days via an online portal. Patients can also tap into telehealth services to discuss their results with a doctor. The antibody testing will be based on tests from Abbott and EUROIMMUN....According to Quest, Abbott reports a 99.4% specificity for its antibody test, and EUROIMMUN AG is reporting a 98.5% to 99% specificity. The tests will be specifically aimed at testing for COVID-19 antibodies, which means the test is not meant to be used to determine whether or not a person is positive for the virus....The other issue is that test results could be positive if a person was once infected with the virus but is no longer ill, according to the agency. Quest specifies this test is not intended for those who feel sick or who have tested positive for the coronavirus within seven days.
This initiative by Quest and LabCorp (see: Quest, LabCorp launch nationwide COVID-19 antibody testing in pharmacies and online) strikes me as disingenuous for the following reasons:
- I am sure that many Americans don't understand the difference between testing for the COVID-19 viral antigen which is diagnostic for the disease as opposed to testing for an antibody to the virus which only indicates prior exposure. Despite the accurate description of the test in the excerpt above, I am sure that many of the consumers who order the test think that it provides them with some actionable information.
- Here is a description of one of the shortcomings of COVID-19 antibody test which calls into question the performance of the test on anyone except for clearly defined sets of individuals such as healthcare workers (see: (see: Q&A on COVID-19 Antibody Tests)):
“These tests are just looking for the presence of antibodies that are able to recognize SARS-CoV-2,” said Lisa Gralinski, a virologist who studies human coronaviruses at the University of North Carolina at Chapel Hill. “They’re not telling us anything about the quality of those antibodies, so we don’t know if they’re neutralizing.”....This is one reason why health experts have been cautious about making sweeping claims that antibody tests can necessarily identify those who are immune, even if scientists think it’s highly likely that a person with antibodies will have at least partial immunity for some period of time.
- This announcement from Quest defines this option as a "consumer-initiated" test that requires approval of one's PCP and for whom, I think, the rationale for ordering the test is weak. It's unknown at this time to what extent the presence of a measurable antibody titer indicates protection from the disease (see: Antibody tests were supposed to help guide US reopening plans. They've brought more confusion than clarity amid coronavirus). I have the hunch, unfortunately, that most physicians will go along with their patients' desire for the test.