The country continues to grapple with the shortage of testing kits for the novel coronavirus (COVID-19) amid the increasing number of those requiring one. Several governors have called for the Centers for Disease Control and Prevention (CDC) to expedite the production and shipping of additional test kits.
But test kit scarcity isn’t the only issue. The nation’s been struggling to turn around results at a fast-enough pace.
"With only one location to perform tests for the whole country, there was limited capacity [to confirm or rule-out a positive diagnosis],” Samuel Sia, Ph.D. and professor of biomedical engineering, Columbia University, told Fox News. “This allowed labs located closest to tested subjects to cut down specimen transport time.”
Initially, the CDC was the only lab with this capacity. CDC headquarters are located in Atlanta. With the increasing spread and number of caseloads across the country, this puts those farther away at a disadvantage.
There was also a manufacturing issue, said E Hanh Le, MD and senior director of medical affairs at Healthline.
When the CDC first distributed the test kits to labs across the U.S. the results weren’t able to confirm if a person under investigation (PUI) were positive or negative for the virus. These samples had to be shipped to the CDC for a proper diagnostic outcome.
“The initial CDC test kits contained a reagent, or chemical, used in processing the samples that led to inconclusive results,” Le said. “It wasn’t functioning properly. This meant the labs processing (outside the CDC) were producing inconclusive results.”
It also takes time to transport specimens even if overnighted. Combined with short-staffed labs and back-logged kits, testing can take up to two days for a result.
The COVID-19 test requires three culture swabs. One from the nose, one from the throat and one from the lower lungs. This requires a person to inhale deeply, cough and spit up saliva and mucous into a sterile collection cup.
Regulations designed to maintain the integrity of the samples and to protect those who are handling the shipping and packaging might also delay transport. Although streamlined and in the care of medical professionals, there are specifications on how the samples are packaged within the container. Specimens must also remain within a narrow temperature range at 2-8 degrees Celsius when shipped.
Currently, there are no FDA-approved diagnostic tests specific for COVID-19. However, through Emergency Use Authorization, the FDA has made available two tests: one through the CDC and one used by the New York State Public Department of Health.
The tests function similarly, but they were developed by two separate organizations. They use the same technology--real-time polymerase chain reaction. It’s the shipping requirements causing delayed test results.
With the CDC test, a clinic would need to send it back to the CDC for confirmation. In addition to that, some of the tests provided by the CDC did not function properly, which necessitated them being run several times for confirmation.
In New York, however, the test was made available at the locations they were needed and did not experience the same functionality issues that the CDC kits ran into.
“Currently, the biggest questions on a lot of people’s minds is whether their clinic or hospital will have valid, reliable tests to provide accurate diagnosis but also whether the testing is accurate in terms of being able to correctly identify people who have been cleared” of COVID-19,” Le said. "We’ve heard of cases where people were cleared and sent home only to return a few days later seemingly ill again.”