At each institution, the results came from a University of Maryland lab in Baltimore that was processing tests produced by the South Korean firm LabGenomics — a replacement batch the state ordered because an initial batch of 500,000 tests was flawed and never used.
Records obtained by The Washington Post show that health officials raised concerns about the reliability of the replacement tests, and the U-Md. lab stopped using them soon after the suspected false positives at Towson and elsewhere.
Gov. Larry Hogan’s administration then pressed the test kits into service at the state’s public health lab, even as the lab’s director expressed doubts.
The public health lab spent weeks preparing to use the LabGenomics kits, the records show. Weeks later, the health department again shifted the tests, this time to a private lab. The decision meant that preparation efforts at the state lab were largely wasted.
U-Md. officials deny the test results were false and say they stopped using the tests, branded LabGun, to make way for others that could also check for influenza.
A spokesman for the state health department, Charles Gischlar, said the tests were moved from the state lab to the private lab in the fall “in order to have them used more quickly,” noting in an email that “these kits all have expiration dates.”
But the tests would not have expired until this spring, records show.
Hogan spokesman Mike Ricci said the replacement test kits were moved from the state lab to the private lab when “state health officials went into all-hands-on-deck mode to make sure all tests were being utilized on the front lines.” He also suggested problems may have stemmed from conditions at the U-Md. lab, even though an investigation into the seeming false positives was inconclusive.
'Inaccurate test results'
A Post investigation in November showed that Hogan and his aides spent months covering up flaws with that first batch and refusing to acknowledge that they had been discarded.
Once the replacement tests arrived, it took weeks to perform studies necessary to begin putting them to use.
In mid-July, U-Md. medical school professor David Marcozzi sent an email to Robert Myers, the public health lab’s director, asking to discuss “the LABGUN test and your thoughts on usability.” They agreed to speak the next day.
Neither Myers nor Marcozzi — who is now Hogan’s senior medical adviser — responded to questions about what issues they discussed. But a study done in May 2020 by a state-contracted lab had found the LabGun tests less accurate and more cumbersome to process than other available brands.
At Towson, officials were working to reopen for in-person classes, putting up plexiglass partitions, configuring classrooms for social distancing and erecting signage about washing hands and wearing masks. Students, faculty and staff members were arriving from across Maryland and out of state.
Each had to provide a negative coronavirus test before returning to classes, offices and residence halls, and the school’s health center was providing them free. Over 10 weeks, from June to mid-August, the school offered thousands of the usually reliable polymerase chain reaction (PCR) tests, school officials said, and only 17 came back positive.
Officials would not say exactly when the U-Md. lab began using the LabGun PCR kits to process swabs from Towson and other institutions. But based on certification, inspection and email records, it appears they were not used in large numbers until August. On Aug. 22, the weekend before classes were to begin, dozens of positive results came in for people who had been tested at the health center and whose samples were processed at the U-Md. lab.
“It didn’t make sense,” said Matt Goldstein, who at the time was director of Towson’s health center. None of those who tested positive had coronavirus symptoms, he said. Some quickly got retested and were negative. “I had this one guy — he told me he hadn’t left his house for three months,” he said.
Goldstein raised concerns to Towson and Baltimore County officials.
“After speaking to concerned individuals daily and seeing the results of our ‘retested’ population, I personally question the validity of our testing,” Goldstein later wrote to Towson’s risk officer in an email released to The Post through the Maryland Public Information Act.
“We all understand the ramifications of inaccurate test results,” Goldstein wrote. “Family members of those testing positive are unable to work for 14 days resulting in financial hardships. Besides all of the volumes of added work that [Towson] staff must do as a result of a positive lab value.”
Towson officials did not publicly acknowledge the questions about the tests’ accuracy, however. As the school contacted students about retesting, employees received an email from Vernon Hurte, vice president for student affairs.
“I wouldn’t [say] anything about possible error,” Hurte wrote, according to a copy of the email released to The Post. “Maybe say we’re conducting additional confirmation. Mentioning a possible error would create confidence issues.”
Days later, Towson went to all-remote classes and began moving students out of the residence halls. In a letter to campus, Towson President Kim Schatzel said of the surge in positive results that “the virus was transmitted through community spread, which simply means the source of the infection is unknown.”
Goldstein remained vocal about his belief that the results were erroneous and was fired a few weeks later. Towson officials cited performance issues. But the state’s legislative auditor, who looked into the matter during a review of the LabGun test purchase, found that Goldstein’s performance evaluations indicated he met or exceeded expectations and “had no areas of deficiencies.”
Towson spokesman Sean Welsh said in a statement on April 30 that “we had no basis for questioning” the test results.
In early September, Howard County health officials learned that about 30 employees of Lorien Columbia nursing home had tested positive for the coronavirus after their specimens were processed at the U-Md. lab. The employees were told to isolate and stay home from work. Another nursing home’s operations were disrupted after it received similarly concerning results.
The university lab’s director, Jeffrey Parker, sent an email to its client nursing homes, saying test results were being investigated. The state epidemiologist, David Blythe, asked Myers at the public health lab for help.
Myers’s lab retested two dozen people from Lorien Columbia using a different brand of test. All came back negative, Myers’s email records show. The lab also performed antibody tests on many who had tested positive for the virus to determine whether they had ever been infected. Most had not. And Myers assessed results from Towson and from Salisbury University, which had also received an unusual number of positives from the U-Md. lab.
Myers said in a statement April 30 that he and his staffers “were not able to establish a root cause for the alleged questionable results.”
U-Md. medical school spokeswoman Deborah Kotz said the lab continues to have “full confidence in the accuracy of our results.”
“After careful review and re-testing of original samples, we found no evidence to suggest that the increase in positivity was due to false positives or a failure of the [test] to perform according to specification,” Kotz said in an email.
In response to a complaint from a nursing home, the state’s Office of Health Care Quality inspected the university lab. Inspectors found shortcomings in how the lab ensured specimens were properly transported and stored but couldn’t identify a cause of the suspected false positives.
The Food and Drug Administration also looked into the issue and contacted LabGenomics, email records show. An FDA spokeswoman said the agency does not comment on investigations.
LabGenomics did not respond to repeated requests to discuss the suspected false positives.
Switching to a new lab
As investigations into the suspected false positives began, the U-Md. lab stopped using the LabGun tests. State and university officials said the move was unrelated to the alleged false positives. Ricci said officials had been planning for the university to switch to a test that could check for both the coronavirus and influenza.
State officials transferred 90,000 of the LabGun tests to the state public health lab and asked Myers when he could start using them. Myers was not enthusiastic.
“Practically speaking the implementation of the Lab Gun assay at the MDH Lab cannot occur immediately,” he told Jinlene Chan, Hogan’s acting deputy secretary for public health services at the time, in an Oct. 1 email.
Myers said he had “serious concerns about the performance of the Lab Gun Assay from data that has been shared with me” by the university lab, and he warned that he couldn’t be certain whether the suspected false-positive results were due to “inherent performance issues with the Lab Gun,” lab errors or some other cause.
He also told Chan that his lab staffers were exhausted from working 12- to 14-hour days, often seven days a week, and would need several weeks of lab work to begin using the LabGun tests, which required a “bridge” study, because they did not have FDA authorization for use on some of the lab’s equipment.
“We cannot and will not compromise the quality of the results that are produced by the MDH Laboratory,” his email said.
Days later, however, Myers told Chan that his lab would start using the LabGun tests. He instructed his staff to write up training manuals and operating procedures, purchase ancillary supplies and finish the necessary studies.
“We have been tasked by senior leadership to bring the Lab Genomics LabGun COVID-19 PCR Assay on-line as soon as possible,” he wrote to his lab employees on Oct. 15.
“Please make implementation of the Lab Gun Assay a priority,” the email said. “I thank you for your cooperation and understanding in this matter.”
Chan said in a statement that while the health department “appreciated Dr. Myers expressing his concerns based on [the university lab’s] processes, it was during a time when some questions may have still been outstanding.”
She said the public health lab validated and “successfully utilized” the LabGun tests and did not report any performance issues.
A private lab based in Frederick, CIAN Diagnostics, had begun using the replacement LabGun tests in July or August, switching from a different brand of test kits to process samples from community testing sites and nursing homes on behalf of the state.
CIAN’s initial contract with the state, awarded in April 2020 for up to $3.9 million, was expanded to $17.6 million in July. The state provided CIAN with LabGun tests at no cost and paid the company the same amount — $98 per test — whether it used the LabGun tests or purchased another brand.
In August, the state reduced CIAN’s rate to $93 per test, while expanding the contract to up to $45 million.
In response to questions from The Post about the suspected false-positive results, CIAN principal Sam Mullapudi said in an email that his lab prefers the LabGun test because of its “robustness and stability.” He said CIAN “has not had problems with LabGun kits with its validated method.”
In an interview last year, Mullapudi said CIAN used the LabGun as a “lab-developed test,” meaning the lab processed the tests using a method that did not match their FDA authorization. Though such changes are not uncommon, Mullapudi declined this month to disclose them or the reasons for them.
The Hogan administration defended the replacement tests vigorously, saying in a statement on Nov. 23 that the state’s Office of Health Care Quality found “no issues whatsoever” with the tests when it inspected the U-Md. lab.
But OHCQ Director Patricia Nay told legislative auditors that her agency never evaluated the reliability of the LabGun tests, according to their report. She told The Post that her agency’s role is “to determine if a laboratory is compliant with federal and state laboratory regulations.”
The governor’s Nov. 23 statement, which was translated into Korean and posted on the LabGenomics website, said the LabGun tests had been successfully used at three Maryland labs, including the state public health lab.
That lab had started using the tests only a few weeks earlier, however. And on Nov. 20, health department officials began transferring its supply of LabGun tests to CIAN.
On Dec. 15, Hogan announced that “as of today, the state of Maryland has successfully utilized every single one” of the replacement tests. He said CIAN had ordered a million more LabGun tests on its own.
Mullapudi said the LabGun is now his lab’s main PCR test.
Ricci cited successful use of the LabGun tests by CIAN and the public health lab as “further proof that any prior issues” were related to the U-Md. lab rather than the tests themselves.
Overall, the state health lab used 3,600 of the LabGun tests — many of them for studies and training — and diagnosed 1,833 people with them, Myers explained in a December email to Webster Ye, a health department assistant secretary.
In the same email, Myers appeared to try to justify the low number of patients diagnosed relative to the number of tests used.
“We assumed that we would be running the [tests] for more than 6 weeks,” he said.
Ovetta Wiggins contributed to this report.