University Stops Using Chinese-Made Testing Kits; Some Were Contaminated

Among the tens of thousands of Covid-19 testing kits procured by the University of Washington School of Medicine from China were some that contained a bacteria in the specimen-preserving liquid, triggering the university to stop using them to test people for coronavirus.

As the South China Morning Post reports, a Seattle importer obtained the testing kits from a Shanghai factory; UW Medicine spent $125,000 to purchase them. But on April 16, Geoff Baird, the interim chair of the University of Washington Department of Laboratory Medicine, heard that vials he had sent contained liquid whose color had changed. He asserted that he was prompted to start “tearing through boxes,” where he found some that had turned orange or yellow instead of hot pink, indicating the presence of bacteria; some also looked cloudy. He confirmed that he had given 20,000 test kits to Public Health–Seattle & King County and another 15,000 to the state’s public health lab, adding, “I don’t know how many they’ve distributed yet.”

Baird stated, “I’ve just recommended everyone who has these things pause and not use them at all. I can’t say I’m not disappointed … We are also, out of an abundance of caution, testing the swabs themselves, which were separately packaged.” He noted that the contamination didn’t have any contact with patients, and thus “we don’t expect there’s any real mechanism of harm to patients.”

“Laboratory testing confirmed there was a bacteria called Stenotrophomonas maltophilia growing in the clearly contaminated samples. But after further examination, Baird said he does not believe the bacterial growth likely affected specimens that have already been analyzed and does not believe anyone will need to be retested,” the South China Morning Post added.

UW Medicine has temporarily stopped using the testing kits from Lingen Precision Medical Products.

Anita Nadelson, the Seattle importer, said the supplier said it would refund the money. She added, “They’re working diligently to identify and cure the issue. We vetted these as best we could. It’s an unexpected turn on both sides.”

Baird said of S. maltophilia, “It lives on surfaces and it lives on factory things and tubing. I would think it’s in your home, my home, it’s on everything.”

Last Sunday, the Washington State Department of Health issued a statement regarding the situation which read in part:

On April 17, 2020, the Washington State Department of Health was alerted by UW Medicine to discontinue use of a recently-procured batch of COVID-19 specimen collection kits that UW Medicine believed may have a quality control issue. As a result, last night DOH recalled approximately 12,000 kits sent to local health jurisdictions, tribal nations, and state agency partners across the state …

Viral transport media (VTM) is the fluid that preserves a specimen during transport, such as one collected via nasal swab from a person being tested for COVID-19. Some of the vials of VTM were an unusual color, which prompted UW Medicine to reach out to DOH to work together to investigate potential contamination. DOH officials believe there is no health risk to patients, as the VTM does not come in contact with patients during a COVID-19 test.

Testing completed today at UW Medicine has indicated that the quality issues observed in the small number of the VTM tubes did not impact COVID-19 test results. While this investigation is still ongoing, DOH is choosing to recall both the VTM and the nasal collection swabs out of an abundance of caution.