Nebraska Public Health Lab Director Peter Iwen put out an APB earlier this week to university and corporate research labs seeking the additional supplies needed to complete the COVID-19 testing process.
The public health lab's supply of extraction kits, which pull genetic material from the samples swabbed from patients potentially infected with the disease to allow testing for the novel coronavirus' presence, are running thin.
Food and Drug Administration Commissioner Stephen Hahn told members of Congress last week the agency is "aware of the pressure in the supply system on the reagents" needed to run the tests.
As of Thursday morning, no labs reported having any available reagent kits to send to the state's public health lab or to Nebraska Medicine, Iwen said, the only two clinical labs capable of performing the COVID-19 identification test.
Iwen says that's a problem.
The lab has been able to procure enough kits to do the necessary testing so far, but a surge in the number of potential COVID-19 cases in Nebraska in the coming week to 10 days — as predicted by state epidemiologist Tom Safranek on Wednesday — could hinder the ability to effectively expand testing of who has the disease.
"The next big crisis, from my standpoint, is the inability to get the reagents necessary to run the COVID-19 ID testing," Iwen said in a phone interview. "We here, as well as every public health lab and most labs in the nation, are trying to use the same vendors for extraction kits to run the test."
Not having the extraction kits is like trying to bake a cake without one of the essential ingredients, Iwen added. If you had eggs and flour, but left out the sugar, the cake wouldn't turn out right.
"We can't run a test if we don't have all of our ingredients, and right now, one of our ingredients is almost impossible to get."
Multiple private companies supply extraction kits, which are used to do research in molecular or microbiology, but the test run by the public health lab is validated by the Food and Drug Administration to run on a particular kit.
That's why Iwen put out a "blast email" to ask if any research labs could dedicate non-expired extraction kits to support their COVID-19 testing efforts.
Iwen said Thursday a second crisis is looming.
"The limitation right now is we don't have enough reagents to run the samples everybody thinks we can run," he said. "But even if we did have the kits, we only have so much capacity that our team can do as well."
Even with "all the reagents in the world," the Nebraska Public Health Lab could still only effectively test 100 to 150 samples per day under its current staffing levels, according to Iwen.
If hospitals and health clinics start drive-thru testing, dramatically increasing the number of potential samples to look for evidence of a coronavirus infection, there are manpower limitations to consider.
The highly sophisticated tests use highly sophisticated instruments, Iwen said, which take time and training to run to the lab's standards.
There are four people capable of conducting the COVID-19 tests at the public health lab, working 10-12 hours a day, seven days a week, for the last month, with a fifth person being trained.
Iwen said he recently pitched an idea of how public health labs could quickly expand testing to meet higher demand under limited supplies and without needing more manpower to the Centers for Disease Control and Prevention that's now is being discussed "at high levels."
It goes like this:
By pooling five samples into a single test, technicians could test more potential patients using a fraction of the reagents needed.
Instead of 25 extraction kits needed for 25 samples, he explained, the lab would need just five extraction kits to test 25 samples.
Pools that come back negative would clear five people at a time while saving "a ton of materials," while a pool that comes back positive would require further testing.
But even if two people out of 25 ultimately tested positive, labs would only use up to 10 extraction kits, rather than burn through 25, he added.
It's "outside the box" of what the Clinical Laboratory Improvement Amendments allows for, Iwen conceded, but his own research shows it could be between 95% and 98% effective.
That's a higher standard than a lot of tests done by the lab, he said.
Iwen isn't sure if the CDC will approve pool testing, but he said he feels it is the right direction.
"I do feel this is the next step we are going to show in Nebraska," he said. "We may have to go to that."