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US University Stops Using Chinese Testing Kits After Some Found To Be Contaminated


The University of Washington School of Medicine went to extraordinary lengths to airlift tens of thousands of Covid-19 testing kits 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 plane. UW Medicine allocated US$125,000 to purchase the kits.

The story of the testing swabs 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.


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Some China-made coronavirus test kits and face masks rejected as ā€˜unreliableā€™ in European countries

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.

ā€œIā€™ve just recommended everyone who has these things pause and not use them at all,ā€ 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. ā€œI canā€™t say Iā€™m not disappointed.ā€

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

Baird said he went immediately to where UW Medicine is storing some testing kits and starting ā€œtearing through boxesā€.

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

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


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Laboratory testing confirmed there was a bacteria calledĀ Stenotrophomonas maltophiliaĀ 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 analysed 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.

ā€œThereā€™s absolutely no difference,ā€ 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.

ā€œTheyā€™re working diligently to identify and cure the issue,ā€ Nadelson said. ā€œWe vetted these as best we could. Itā€™s an unexpected turn on both sides.ā€


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

ā€œWe are also, out of an abundance of caution, testing the swabs themselves, which were separately packaged,ā€ Baird said.

Because the contamination was found in the specimen-preserving liquid, which makes no contact with patients, Baird said ā€œwe donā€™t expect thereā€™s any real mechanism of harm to patientsā€.

Baird saidĀ S. maltophiliaĀ is ā€œubiquitousā€ and a common contaminant.

ā€œIt lives on surfaces and it lives on factory things and tubing,ā€ he said. ā€œI would think itā€™s in your home, my home, itā€™s on everything.ā€

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

Baird said he gave 20,000 test kits to Public Healthā€“Seattle & King County and another 15,000 to the stateā€™s public health lab.

ā€œI donā€™t know how many theyā€™ve distributed yet,ā€ 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.

ā€œWe are working with our partners to have them discard the product and will work to replace them as quickly as we can,ā€ 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.


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

ā€œAbout 5,000 of the 20,000 they gave us had been distributed by us, and approximately 300 had been used,ā€ said James Apa, a Public Healthā€“Seattle & King County spokesman, adding that ā€œthe problem with the kit itself shouldnā€™t present any health risk to patientsā€.

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

ā€œWe should be doing more, but weā€™ve not seen our volume go up,ā€ Baird said of testing at the UW Medicine Virology Laboratory. ā€œThereā€™s a cap on the amount of testing that can be done globally, and certainly nationally, there arenā€™t enough kits for swabs and VTM (viral transport media) for testing.ā€

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

ā€œThis is a bump in the road,ā€ he said. ā€œWeā€™re going to get past it. We have no choice.ā€

Story cited here.

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