UW Medicine Halts Use of Coronavirus Testing Kits Airlifted From China After Some Had Contamination


UW Medicine went to extraordinary lengths to airlift tens of thousands of testing kits for COVID-19 from China during a nationwide shortage of sampling swabs and the liquid that preserves specimens for diagnostic testing.

In short: A Seattle importer used a business associate in China, who had a connection to a doctor in the province hardest hit by the disease, to secure testing kits from a Shanghai factory and then have them flown stateside as soon as possible on an Amazon-chartered jet. UW Medicine allocated $125,000 to purchase the kits.

The story of the testing swabs, which The Seattle Times detailed earlier this month, illustrated what authorities are willing to risk to secure more supplies for COVID-19 testing, which experts say will need to ramp up before distancing restrictions in Washington can be safely removed.

Late last week, the saga took a dour turn.

UW Medicine has decided to halt, at least temporarily, the use of the testing kits from Lingen Precision Medical Products, after a small percentage of the kits showed signs of contamination.

"I've just recommended everyone who has these things pause and not use them at all," said Geoff Baird, the interim chair of the University of Washington Department of Laboratory Medicine, who was part of the group that went to great lengths to secure the materials. "I can't say I'm not disappointed."

Baird said he first learned of a problem April 16, when a colleague notified him some of the liquid in vials he had sent appeared to have changed in color.

Baird said he went immediately to where UW Medicine is storing some testing kits and starting "tearing through boxes."

Many of the vials appeared to be fine. But the liquid in a small percentage of them had turned to an orange or yellow color, rather than hot pink, an indication of bacterial growth. Some appeared cloudy, too.

Baird estimated no more than a few percent of the test kits he viewed had been affected.

Laboratory testing confirmed there was a bacteria called Stenotrophomonas maltophilia (S. 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.

He said scientists added known samples of the novel coronavirus to the contaminated specimen-preserving liquid, called viral transport media, and compared it against uncontaminated liquid.

"There's absolutely no difference," he said.

Baird said he had paused some additional orders.

Anita Nadelson, the Seattle businesswoman who helped secure the swabs through Chinese business contacts, said the Chinese supplier had said it would refund the investment.

"They're working diligently to identify and cure the issue," Nadelson said. "We vetted these as best we could. It's an unexpected turn on both sides."

Baird said the laboratory on Sunday was taking another look at the swabs, too.

"We are also, out of an abundance of caution, testing the swabs themselves, which were separately packaged," Baird said.

Because the contamination was found in the specimen-preserving liquid, which makes no contact with patients, Baird said "we don't expect there's any real mechanism of harm to patients."

Baird said S. maltophilia is "ubiquitous" and a common contaminant.

"It lives on surfaces and it lives on factory things and tubing," he said. "I would think it's in your home, my home, it's on everything."

On its website, the National Institutes of Health says S. maltophilia can cause problems in people with a weakened immune system or in hospital settings.

Baird said he gave 20,000 test kits to Public Health -- Seattle & King County and another 15,000 to the state's public health lab.

"I don't know how many they've distributed yet," he said.

In a news release Sunday, the state Department of Health said it had recalled about 12,000 kits sent to local health jurisdictions, tribal nations and other partners.

"We are working with our partners to have them discard the product and will work to replace them as quickly as we can," said John Wiesman, the state secretary of health, in a statement.

The health department said it did not have adequate supplies to replace all the swabs and transport media, though a large shipment of swabs from another vendor of swabs is expected later this week.

Public Health -- Seattle & King County said it reached out immediately to its local partners, asking them to suspend use.

"About 5,000 of the 20,000 they gave us had been distributed by us, and approximately 300 had been used," said James Apa, a Public Health -- Seattle & King County spokesman, adding that "The problem with the kit itself shouldn't present any health risk to patients."

Meanwhile, Baird said national shortages of testing kits remains dire.

"We should be doing more, but we've not seen our volume go up," Baird said of testing at the UW Medicine Virology Laboratory. "There's a cap on the amount of testing that can be done globally, and certainly nationally, there aren't enough kits for swabs and VTM [viral transport media] for testing."

Baird said he expects to be seeking new supplies for months.

"This is a bump in the road," he said. "We're going to get past it. We have no choice."