On Monday, President Donald Trump announced that the United States has tested more than 1 million people in the country for the novel coronavirus, a milestone that seems to show an American COVID-19 testing regime in motion.
Yet even as the FDA cleared the way towards more rapid procedures over the last month – loosening the rules for test development and distribution at the local level – other problems remained. No longer do we need to worry about a single authorized test protocol, or a limited amount of laboratories permitted to carry out the test, but what goes into a test itself.
The current concern lies in the serious shortage of materials needed to manufacture tests of any capacity. It’s the lab equipment, personal protective medical gear, test swabs and reagents critical to identify the virus that are running out.
But not if UCSB has anything to say about it.
In true Santa Barbara-fashion, professors Max Wilson, Carolina Arias, Kenneth Kosik and Diego Acosta-Alvear, all from the university’s Department of Molecular, Cellular and Developmental Biology, have donated essential supplies to Cottage Hospital to aid in coronavirus testing. These include the reagents, or ingredients, necessary to detect signs of COVID-19 in a given patient sample. Without these reagents, the SARS-CoV-2 viral sequence would be all but invisible to detection.
To identify this sequence, typical testing for COVID-19 works as follows. After visiting a testing site, a Q-tip is inserted in the nose or the back of the throat to collect a swab sample. That sample is then sent off to a lab. Once there, the specimen is processed, meaning lab workers extract the virus’s genetic material made out of RNA. Next, technicians run a “polymerase chain reaction (PCR)” test, which selectively amplifies the virus RNA to a level that can be detected with a specialized instrument. If the test finds two specific SARS-CoV-2 genes within a specimen, the sample is positive for COVID-19.
World Health Organization and CDC testing protocols rely on the PCR test, making these reactions integral to any diagnosis.
“The PCR is the gold standard because that is what is approved and used by the CDC,” said Dr. Acosta-Alvear.
On a good day, the reagents that make this reaction possible can be ordered and sent to a lab without a hitch. These days, however, the critical supply chain has taken a hit, as countries around the world scramble for materials.
“The supply chain for the reagents is broken,” said Dr. Acosta-Alvear. “You need the supply to fill that need so tests are accessible.”
As the supply for testing reagents dwindled worldwide, Cottage Hospital turned to Dr. Acosta-Alvear and his fellow UCSB professors for help, who are working on developing new strategies for surveillance testing.
“Our goal is to understand how the virus spreads in our community” said Dr. Acosta-Alvear.
Approximately 18 days ago, in the face of growing public health concerns, the professors dropped their individual research projects to focus on studying the infection rate of COVID-19 in Santa Barbara. Though the specifics of their study are not yet ready to be disclosed, as the program is pending institutional approval, it requires similar materials to those used for diagnostic testing. So, when Cottage came knocking at their door, the professors were happy to donate reagents that would help Cottage in its mission.
“When Cottage reached out, we all said, ‘Of course we’ll share with you some of our materials to help you diagnose people,’” said Dr. Acosta-Alvear.
“We can purchase reagents to perform COVID-19 tests, but only for research purposes. We do not have clearance to perform any type of diagnostic test and we cannot deliver results to patients. Therefore, we gave the reagents to clinicians to do diagnostics. That way, Cottage can start screening patients that come into the clinic.”
The professors donated enough materials for 600 reactions, which can enable anywhere between 200-400 tests. Though not nearly adequate for the level of testing that will be eventually required, the donation provides a substantial buffer while suppliers restock, Dr. Acosta-Alvear explained.
Still, even that buffer won’t last.
“The supply will be replenished, but the virus is exploding exponentially,” he said. “We’re going to need millions of tests nationwide with the rate of infection scaling up. It’s getting really hard to keep up with demand.”
Instead, Dr. Acosta-Alvear called for alternative forms of testing other than the PCR method described above, something they are exploring themselves.
“We need more testing that can be rapidly deployed,” he said. “We are working on a different kind of test that would be more deployable in the field, which will complement the current PCR-based standard.”
Together, the researchers hope to fill the gap in widespread testing, a problem that threatens to prolong the already enduring pandemic.
“The worldwide need for accurate and fast testing remains unmet,” said Dr. Acosta-Alvear. “I’m not saying suppliers aren’t doing their part. They’re working hard to produce the reagents necessary for the (PCR) tests.
“There’s just so much need. And if we have learned anything from other countries that have endured the contagion, is that widespread testing pays off, as it allows us to make informed, strategic decisions on containment and medical care measures.”