“There have been a number of unfounded rumors and blatantly false accusations regarding the COVID-19 tests which the State of Maryland acquired in coordination with the South Korean government and the Korean Embassy in Washington, D.C.
There have been no faulty or failed Korean tests. The state has successfully utilized nearly 395,000 of the LabGenomics tests, and they remain the cornerstone of Maryland’s long-term testing strategy.
While the entire testing process has been a struggle at the federal and state levels, and there have been and continue to be challenges, these Korean test kits represent one of the greatest success stories of our battle against COVID-19.”
- Fiction: The initial tests that the state acquired were flawed, did not work, and the money was wasted.
Facts: The initial tests were successfully validated and usable. When a change in FDA emergency protocols occurred, LabGenomics agreed to immediately replace and upgrade the tests for even faster, more sensitive tests at a nominal cost. Once our scientists verified the protocols and got these tests up and running, the governor publicly announced the swap, and the emergency procurements were unanimously approved by the bipartisan Board of Public Works.
- Fiction: The test kits that the state acquired were missing parts.
Facts: The test kits were not missing any parts. At the initial announcement of the acquisition, the governor said, “It’s a very complex set of things that goes into the testing. … As I understand it, there are about nine steps involved in the process,” including lab capacity, swabs, reagents, and transport media. The state worked hard to successfully acquire all of these components.
- Fiction: The test kits should have been sent to counties to use.
Facts: This demonstrates a misunderstanding of how the testing process works. These are test kits that can only be used in highly specialized labs. They are not swabs or collection tubes. The state regularly deploys tests to aid local jurisdictions.
- Fiction: The state could have gone to other sources for tests.
Facts: Without a federal testing strategy, states were going to every foreign and domestic source they could find for tests. South Korea set the standard for high-volume testing, and LabGenomics was on a list of manufacturers shared with the Maryland Department of Health by the office of Sen. Chris Van Hollen and the Korean Embassy. At the time of their acquisition, the quantity of LabGenomics tests we acquired exceeded the total stockpiles of four of the top five states in the United States combined.
- Fiction: The tests have not been used.
Facts: Nearly 395,000 of these tests have been successfully utilized at three separate labs. The LabGenomics tests remain the cornerstone of the state’s long-term testing strategy. We anticipate using every single one of them. Over the summer, when many states were facing shortages and long backlogs, our strategic stockpile of these tests was turned around in 24-48 hours. And in the fall surge, these tests are meeting the increased demand at our state-run community-based sites.
- Fiction: The state was not transparent about the upgrade of the tests.
Facts: Once our scientists verified the protocols and got the tests up and running at the lab, the governor announced the trade-in and upgrade, and the emergency procurements were approved unanimously by the bipartisan Board of Public Works at a public hearing after a thorough review process.
- Fiction: Legislators were not consulted on or informed about the upgrade of the tests.
Facts: Although the General Assembly is not in session until next year, state health officials have repeatedly taken time away from their life-saving work in the middle of a state of emergency to provide detailed briefings to legislators, and answer all of their questions.
- Fiction: The state should have gone through the normal procurement process.
Facts: We are in a state of emergency, with lives at stake. We are not required to, could not, did not, have not, and will not utilize a normal protracted procurement process. This has been a race to acquire such critical life-saving supplies as PPE, ventilators, N95 masks, and test kits. The bipartisan Board of Public Works has reviewed and approved these emergency procurements.
- Fiction: The University of Maryland, Baltimore (UMB) lab stopped using the tests because they were faulty.
Facts: State health officials were in discussions with UMB over the summer about transitioning to multiplex flu assays for the fall, and us moving the bulk of our LabGenomics tests to CIAN Diagnostics in Frederick. Both labs are performing testing as planned and on schedule. Maryland’s State Public Health Laboratory is also utilizing LabGenomics tests on a daily basis.
- Fiction: There were problems with the tests that led to false positives at nursing homes.
Facts: An independent inspection by the Office of Health Care Quality identified minor errors and issues with specimen collection and processes, but no issues whatsoever with the Korean LabGenomics test kits themselves.