The company, which manufactures dietary supplements for the practitioner channel, said it is using an FDA-approved blood serum test that is designed to detect antibodies to the virus that causes COVID-19 (the virus is named SARS-CoV-2.) The test results may indicate one of three primary outcomes:
- Active infection
- Past infection and some level of immunity
- No exposure and no immunity.
Testing for employees, contractors
The tests were done for employees and contractors at locations in Florida and Connecticut on Thursday, April 16. Tests will be done in other locations as phlebotomists become available and local regulations permit, DFH said.
“The test is one of the first indicators that will help organizations, companies, medical professionals, etc., to begin the process of assessing how to roll out a back to work strategy. Currently there are no guidelines as to how companies and people should prepare for this, though we believe tests such as this will form part of this guidance,” said Dr David Brady, Chief Medical Officer, for both Designs for Health, Inc., and partner firm Diagnostic Solutions Laboratory.
Diagnostic Solutions Laboratory (DSL) has developed three tests for COVID-19 and SARS-CoV-2: an oral and nasopharyngeal swab diagnostic test for COVID-19, and a stool analysis and blood serum test for SARS-CoV-2. The blood serum test provides information about whether an individual’s immune system has responded in some way to an exposure to SARS-CoV-2. The results will help understand whether an individual has been exposed to the virus, and if so, whether some level of immunity is present.
DFH said that as a blood draw is necessary, these tests will only be conducted under the order of an appropriately licensed healthcare provider and administered by licensed phlebotomists, and the results are strictly governed by HIPAA regulations.
“This is a much more accurate test than the bloodspot test that is also currently being used on individuals who are asymptomatic. Without doing a blood draw and getting enough serum, you cannot accurately find people who have been exposed in the past, and, more importantly, have some level of immunity,” said Tony Hoffman, president and CEO of Diagnostic Solutions Laboratory.
Peace of mind
Jonathan Lizotte, Founder and Chairman of Designs for Health, Inc., said having the testing information means employees could come to work with more peace of mind.
“All the tests will be performed by Diagnostic Solutions Laboratory, and the results will be sent directly to each individual along with general information about the range of possible results. DFH will have no access to the employees’ individual results, which are their personal health information. We have instructed people whose antibody test shows they may be fighting an active infection to self-quarantine and contact their healthcare provider right away,” he said.
The companies also said that testing of this sort could add to the growing scientific understanding of how the disease is transmitted through a population. It will likely never be feasible to test all Americans in this way, but having statistically significant samples will help inform policymakers’ decisions, they said.