Hundreds of thousands of coronavirus tests that Gov. Larry Hogan bought from South Korea in April to much fanfare appear to be showing reliability problems, returning a spate of false positive results to nursing homes around the state.
The Republican governor already has drawn sharp questions from Democrats about the value of the tests from LabGenomics, which initially had a $9 million price tag, but records show cost the state another $2.5 million for an “upgrade” that has not been fully explained.
After processing thousands of the LabGenomics' LabGun tests, the University of Maryland lab in Baltimore has stopped using them, confirmed university spokesman Kevin P. Kelly. The state gave the school $2.5 million in April to outfit the lab there to process the tests.
“We are no longer using LabGun,” Kelly wrote in an email. “We are unable to comment further since we are still in the process of investigating.”
Kelly said the lab is investigating tests that returned positive results between Sept. 2 and Sept. 8. He said the tests can be affected by factors including viral load, age of the sample and test performance. The investigation so far has shown “no significant issues” related to lab equipment or operations.
Kelly said the lab is no longer using the LabGenomics LabGun tests, replacing the tests with one developed by the U.S. Centers for Disease Control and Prevention that the lab plans to modify so it can test for both the flu and COVID-19, the disease caused by the coronavirus.
The lab is conducting retests at no cost to clients with concerns about their tests. The lab has conducted tests for nursing homes, colleges and universities, jails and prisons, and community testing sites, including the Baltimore Convention Center.
A representative of the nursing home industry confirmed that there has been a spate of false positives in several facilities.
“Last week we became aware that a handful of nursing homes in Maryland had received dozens of false positive tests from samples sent to the University of Maryland lab,” said Joseph DeMattos Jr., president of the Health Facilities Association of Maryland, which represents many of the centers.
“Fortunately the folks at the nursing homes realized that there was likely a problem with the false positive results almost immediately based on their experience with testing over the last two months,” he said.
DeMattos said the facilities have been conducting weekly tests since May 29 and thought the spate of positives — including more than 30 at one facility — was unusual, particularly because the majority of people had no symptoms. The facilities worked with local hospitals and the county health department to retest and most tests came back negative, he said.
DeMattos said the nursing homes alerted the state and his group.
No one would disclose which facilities recorded the spate of false positives. Nursing homes are required to conduct weekly testing of staff and residents. Initially the state paid for the tests, but stopped doing so in mid-August.
While repeat testing due to questionable results can drive up costs, DeMattos said the bigger concern is the effect on residents who receive positive tests and must be isolated. Nursing homes were an early and large source of coronavirus spread in Maryland and have accounted for more than 15,000 infections and more than 2,000 deaths between staff and residents.
Asked for comment on the issues with the LabGenomics tests, a spokesman for Hogan deferred to state health officials.
Charlie Gischlar, a spokesman for the Maryland Department of Health, responded in an email that the state appreciates the University of Maryland lab “looking into recent reports of false positives coming from its lab, and finding no significant issues.”
State officials downplayed the investigation into the false positives and said the discontinuation of the LabGenomics tests at the university lab was due to the transition to the CDC tests.
State lawmakers have questioned health officials repeatedly about how the tests have been used.
“It was not transparent from the very beginning — the cost of it, that they were incomplete, that they couldn’t be used for months, then we were told they were going to be put aside for later,” said Sen. Paul Pinsky, who chairs the state Senate’s health committee. “Now ‘later’ is here and we find that the university lab that had been lauded as the facility that was going to be using them now says there are problems.”
Pinsky, a Prince George’s County Democrat, said it’s “unconscionable” that the state has not been clear about the shortcomings with the tests.
“I think the whole thing is an embarrassment,” he said.
During a presentation to state lawmakers Wednesday, Dennis Schrader, deputy state health secretary, said the LabGenomics tests were a “godsend,” particularly this summer when outbreaks elsewhere led to delays at commercial labs. He did not mention any issues with the tests, the discontinuation of their use or the switch to the CDC tests.
State officials have given incomplete information about the use of the South Korean tests. In June, the tests appeared not to be in use yet, and then in July officials said they were first used for “high-priority clusters and outbreaks" and then at nursing homes.
During the presentation to the General Assembly, health officials said the 500,000 tests were sent to two labs, the University of Maryland lab and CIAN Diagnostics in Frederick.
Of the 370,000 tests sent to the University of Maryland lab, 138,000 were used as of Sept. 15.
Of the 130,000 sent to CIAN, about 72,000 have been used. CIAN officials did not respond to a request for comment.
The 210,000 LabGenomics tests that have been administered have been used in the last 60 days, according to state officials.
It’s unclear what will happen to hundreds of thousands of LabGenomics tests that have not yet been used.
Sen. Clarence Lam, a doctor, said he’s been frustrated continually in trying to get answers about the LabGenomics tests.
“It’s been a never-ending horror story with these tests" said Lam, a Democrat who represents parts of Howard and Baltimore counties. “Honestly, at this point, it probably would have been better if these South Korean tests the governor bought had just been empty boxes.”
Lam said nursing home residents who receive false positives may be moved into units with coronavirus-positive patients, putting them at risk of contracting the virus.
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“These false positives are not without consequences,” he said.
Del. Shane Pendergrass said the state has done some things right, such as setting up community testing sites. But there remain so many unanswered questions about the state’s coronavirus response, including about the South Korean tests.
“We’ve asked the questions,” said Pendergrass, a Howard County Democrat who chairs the House’s health committee. “We don’t have the answers."
Del. Maggie McIntosh, chairwoman of the House Appropriations Committee, said this is yet another example of lawmakers and the public being kept in the dark about the effectiveness of state spending.
McIntosh said the state spent nearly $12 million on the tests, “and now we find out they’re not worth 12 cents.”
McIntosh, a Baltimore Democrat, said she supported extending the governor more authority to handle the pandemic, but now she thinks there needs to be better communication between the executive and legislative branches.
“I’m a huge believer in having more than one set of eyes look at a policy or a procurement,” she said.