Lab: 25K COVID-19 test results are reliable
CEO disputes health system claims, stands by company’s results
The CEO of the laboratory at the center of AdventHealth COVID-19 testing problems says that even though his company fell behind in processing the samples, the results of the tests are reliable.
“You can go after me because I didn’t meet your capacity and I couldn’t deliver on your drive-thru testing because of things that I couldn’t control, but don’t attack the reliability of my test,” said Rick Martin, CEO of MicroGenDX, which is headquartered in Orlando and has its lab in Lubbock, Texas.
On Saturday, AdventHealth said the results of more than 25,000 COVID-19 tests done in Central Florida are unreliable and that it had ended its contract with the third-party lab. The health system said it had asked the company, which it didn’t name, to destroy the samples that were not processed and outlined retesting guidelines for consumers who had received results.
But Martin, who said MicroGen has run more than 60,000 tests for AdventHealth in Florida, is stand
ing by the results.
“We work with top institutions from Mayo Clinic, Cleveland Clinic, Duke and Rush, and that’s why it’s really disheartening for them to say that the test is not reliable,” said Martin, a former Army officer.
In response to Martin’s claims, AdventHealth said on Monday, “We stand by our initial statement and have notified the appropriate regulatory agencies of the issues we experienced with this lab. Our complete focus is on notifying and accommodating every consumer who has been impacted by this situation.”
AdventHealth didn’t provide details about the issues with MicroGenDX.
During a press briefing on Monday afternoon, Orange County Mayor Jerry Demings said that 8,100 of the 25,000 tests were in Orange County. And about 3,600 of those individuals never received their results.
“My main concern is, I want our residents to feel confident that they have the opportunity to be tested and get accurate results,” Demings said. “We want to work with the Orange County Health Services Department and the Orange County Health Department to use the full breadth of our various testing sites to be able to retest those individuals.”
He said he wasn’t concerned that the issue could potentially skew Orange County’s COVID-19 data.
Martin said his lab’s capacity was significantly impacted because of the Defense Production Act, which was invoked in late March, allowing President Trump to direct private companies to give priority to orders from the federal government. For instance, Trump ordered General Motors to produce ventilators and 3M to produce N95 masks for the government.
Martin had placed orders for a machine that extracts RNA — the genetic material of coronavirus — out of patient samples from Thermo Fisher Scientific, a maker of lab supplies and sequencing machines. He had also ordered disposable plastic pieces that are used to run samples in the machine.
The machine was critical to MicroGen’s ability to keep pace with the volume of samples, Martin said. But he received neither of his orders.
“Essentially, the government went to companies like Thermo Fisher and told them, ‘We don’t care if MicroGen had ordered that machine, we’re telling you you’re not going to send it there. We are going to tell you where you’re going to send your equipment,’” said Martin. “I couldn’t have planned for this.”
He said he asked AdventHealth to slow down, but the boxes of samples kept coming.
It’s not clear if MicroGen’s capacity is linked to AdventHealth’s closure of its drive-through sites. For nearly a month, the health system offered drivethrough testing in five locations in Central Florida, conducting more than 18,000 COVID-19 tests. The sites were closed at the end of last week because of a decline in demand, the health system said.
Meanwhile, issues with AdventHealth’s electronic medical records system began to crop up, Martin said.
“We had thousands of orders daily that we weren’t getting the patient information,” said Martin. “I can get the sample and then I can run it, but I don’t have the patient information and I can’t link the results of the sample with the patient information.”
MicroGen, which is certified by Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP), received expedited approval from the FDA on March 31 to run its COVID-19 test.
Martin said he has asked CAP to do an inspection of its facility and processes.
Martin said he has emailed AdventHealth, saying that their claim about reliability of his tests has no scientific support.
Meanwhile, consumers like Dave Brim of Port Orange now have to find different location if they want to get retested.
Brim was tested at AdventHealth’s drive-through site at Daytona International Speedway on April 30 after learning that the person who worked on his golf cart had tested positive for COVID-19.
He still hasn’t received any results. You can reach me at nmiller@orlandosentinel .com; call, text, Signal at 321-710-7947; on Twitter @NaseemMiller and on Facebook. Editor’s note: AdventHealth is an advertising sponsor for the Orlando Sentinel’s coronavirus channel but has no input or influence on editorial decisions or content.