by Terry Rogers
On Friday, April 3, The Lab at Seascape in Milford, DE began offering COVID-19 rapid tests they had received from Pinnacle BioLabs. The tests are designed to look for the IGM antibodies that indicate exposure to the virus. The lab was charging $40 in administrative fees to those who made appointments unless they were healthcare workers or first responders. On Monday, April 6, the lab received a cease and desist order from the State of Delaware.
“This is the same test the Department of Public Health is using and announced they had received on Saturday,” Karen Coverdale, Executive Director of the Lab at Seascape said. “We received them a little earlier because we went directly to the distributor. As soon as we put the information out on social media, we began getting kickback from healthcare professionals who claimed this type of test did not exist. This led a lot of people to claim we were a scam or were taking advantage of people which was simply not at all true.”
According to Jeff Sands, Community Relations Coordinator for the Delaware Emergency Management Agency, the order delivered to the Lab at Seascape by DPH was due to the fact the lab was charging direct-to-consumer costs associated with the test which is specifically prohibited by Governor Carney’s Eighth Modification of the Declaration of a State of Emergency.
“The Lab at Seascape was ordered to cease and desist charging these costs to consumers,” Sands said. “The order also required the Lab at Seascape to forward all COVID-19 tests to DPH. The lab was only providing positive test results to the Division of Public Health and DPH requires all test results, both positive and negative, to be reported by labs. Finally, the order requires the lab to educate individuals about what a negative test result means. Testing is an important component of the statewide response to the ongoing COVID-19 pandemic. While the Division of Public Health wants to encourage accessible testing throughout the state, that testing must be coordinated with DPH and labs must follow established procedures.”
The test, which provides results within 15 minutes, requires a finger prick which is then examined for the antibodies. Coverdale stated that, on Friday, they had approximately 10 percent positive tests and that these were people who were asymptomatic. On Monday, that number doubled to almost 20 percent.
“If they test positive, we tell them not to panic,” Coverdale said. “We tell them to go home and self-quarantine for 14 days. They need to stay away from family, from friends and not go out in public for at least two weeks. If they develop symptoms, they should contact their doctor for the next steps. We also send any positive results to the Department of Public Health who then follows up with the patient as to what they need to do.”
Coverdale explained that a negative test does not mean that someone can simply go about their business and not follow social distancing procedures. A positive test also does not mean that someone is immune from catching the virus. They may be in the early stages of the virus where they are contagious but have no symptoms. Coverdale also explained that some people who test positive may never develop symptoms but there is too much unknown about the virus to say that for sure.
“We charged $40 to cover our administrative costs,” Coverdale said. “I am paying administrative people who are putting their own lives at risk. I am paying lab technicians who are risking their own health. I have to pay these people. The tests were not cheap, but I am not trying to recover that cost. The cease and desist does not say I cannot perform the tests. It simply says I am not permitted to charge for them.”
Coverdale explained that she was hoping to take some of the burden from the State which is overwhelmed with requests for testing. Since little is known about the long-term details surrounding the virus, she hopes that this type of testing can be used as a tool to learn more about how the body could fight the virus and create antibodies to prevent someone from getting sick in the future.
“There are also reports that scientists are working with the plasma of people who have recovered in order to create treatments or vaccines,” Coverdale said. “This test may be a step in moving that type of research along. We just don’t know enough about this virus to know what is going to be the big breakthrough. I am not a doctor. I don’t know whether you can build immunity or if using plasma from recovered patients will actually help someone recover. But I believe it is tests like this that will provide us with more information than we currently have. Balking at a $40 charge does not seem to be logical in a time like this.”
Coverdale has spoken to DPH and says that those she has talked to so far are sympathetic, but they must follow the law which states there can be no charge for COVID-19 tests of any type. She plans to hire an attorney in order to appeal the decision. Until then, the lab will no longer be offering the rapid tests.