The U.S. Food & Drug Administration issued emergency use authorization for the coronavirus saliva test today, Saturday, August 15, 2020. The test, called SalivaDirect, uses a new method of processing saliva samples in COVID-19 testing.
Today, there are 5,285,546 cases of the coronavirus in the United States, up by 56,729 from August 14, 2020. There have been a total of 167,564 deaths due to COVID-19, an increase of 1,229 since yesterday, according to the Centers for Disease Control and Prevention. See a map of the data here.
Here’s what you need to know:
1. The New COVID-19 Testing Method, SalivaDirect, Was Called ‘Groundbreaking’ by FDA Officials
The new COVID-19 saliva test, SalivaDirect, was described as “groundbreaking” by public health officials. It is being touted as a less expensive way to test, in a less invasive manner, which also reduces the risk of contagion to medical professionals.
“The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another testing innovation game changer that will reduce the demand for scarce testing resources,” said Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, M.D. in an FDA statement. “Our current national expansion of COVID-19 testing is only possible because of FDA’s technical expertise and reduction of regulatory barriers, coupled with the private sector’s ability to innovate and their high motivation to answer complex challenges posed by this pandemic.”
FDA Commissioner Stephen M. Hahn, M.D. said the testing method is groundbreaking in its efficiency.
“Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s authorization is another example of the FDA working with test developers to bring the most innovative technology to market in an effort to ensure access to testing for all people in America. The FDA encourages test developers to work with the agency to create innovative, effective products to help address the COVID-19 pandemic and to increase capacity and efficiency in testing.”
2. The COVID-19 Saliva Test Was Developed at Yale in Partnership with the NBA & NBPA
Researchers at Yale teamed up with players in the NBA and the National Basketball Players Association (NBPA) to develop the new coronavirus testing method, which is considered to be a breakthrough. The goal was “to study the efficacy of a saliva-based method that quickly determines if someone is infected with the novel coronavirus,” Yale said in a statement provided to USA Today in June.
Players had the option to submit samples voluntarily and participate in the study beginning in June.
“Our players are excited to be a part of this study,” NBPA chief medical officer Joe Rogowski told USA Today. “Not only does it offer the potential for players to have an alternative method of testing within the NBA Campus in Orlando, but more importantly it allows them to leverage their regular testing to make a larger contribution to public health in the fight against this virus.”
The NBA also addressed saliva testing in its extensive return-to-play document.
“Yale researchers have identified saliva as potentially a reliable and sensitive specimen for the detection of the coronavirus, although the efficacy of saliva for a sensitive test in asymptomatic individuals has not been demonstrated,” the NBA said in the document. “To enable saliva to reach its surveillance potential, Yale researchers will conduct optimization, robustness, and sensitivity experiments by comparing the results of de-identified saliva testing against de-identified testing conducted via swabs.”
3. A Yale Scientist Said She Expects Labs to Charge About $10 for the COVID-19 Saliva Test
The COVID-19 saliva test is less invasive, and expected to be cheaper, experts said. Anne Wyllie, an assistant professor and associate research scientist at the Yale School of Public Health, told USA Today she expects that labs will charge about $10 for the test.
SalivaDirect tests uses an open source testing method, “meaning that designated laboratories could follow the protocol to obtain the required components and perform the test in their lab according to Yale’s instructions for use,” the FDA said in a statement.
The method also requires less training and provides less risk to health workers.
“Wide-spread testing is critical for our control efforts. We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample. If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine,” said Nathan Grubaugh in a statement from Yale, who spearheaded testing along with Wylie.
4. The SalivaDirect Testing Method Does Not Require a Medical Professional to Swab a Patient, Reducing Contact & Resources
The COVID-19 saliva test, SalivaDirect, requires only that a patient provide a sample of saliva in a sterile container. This has several benefits, according to an FDA statement. It does not require a medical professional to swab a patient, making it a far less invasive procedure than the nasal swab test. The method also limits the contact between a patient and the medical professionals.
The testing method reduces patient discomfort. The test also does not require a separate nucleic acid extraction step, making it unique from other methods.
“This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past. Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources. Additionally, the SalivaDirect methodology has been validated and authorized for use with different combinations of commonly used reagents and instruments, meaning the test could be used broadly in most high-complexity labs,” the FDA statement said.
5. SalivaDirect Can Double Capacity at Labs, Said a Yale Professor
Yale scientists Anne Wylie and Nathan Grubaugh, who spearheaded the testing project at Yale, said in a statement their goal was to simplify testing, not commercialize their testing method. Long delays and shortages in testing have created roadblocks in COVID-19 mitigation efforts. According to Yale, some experts have said that up to 4 million tests are needed per day.
“Using SalivaDirect, our lab can double our testing capacity,” said Professor Chen Liu, chair of Yale Pathology, who oversaw the clinical validation of the study.
In the coming days, Liu will begin offering SalivaDirect as a testing option in their CLIA-certified clinical laboratory.
“This is a huge step forward to make testing more accessible,” said Chantal Vogels in Yale’s statement. Vogels is a Yale postdoctoral fellow, who led the laboratory development and validation along with Doug Brackney, an adjunct assistant clinical professor.
“This started off as an idea in our lab soon after we found saliva to be a promising sample type of the detection of SARS-CoV-2, and now it has the potential to be used on a large scale to help protect public health. We are delighted to make this contribution to the fight against coronavirus,” she said.”