FDA greenlights DIY at-home swab and saliva tests as it expands coronavirus testing in US
The country's testing capacity is woefully short. To address the growing need, the US Food and Drug Administration (FDA) has recently approved a swab and a saliva test -- both of which allow users to collect their samples at home.
In addition to allowing large-scale testing, these tests can protect healthcare workers from getting infected. On April 16, the FDA issued a press release stating that it had approved a synthetic swab, which is more user-friendly and comfortable. Users can use the Q-tip-type swab to collect their samples from the front of the nose.
Earlier this week, the FDA approved another test through which users can collect saliva samples and ship them to a lab for processing.
According to the COVID-19 tracking project, a website that maintains records of testing in the US, the country has carried out 3.4 million tests.
State health officials and medical providers around the country told The New York Times that they are unable to test as many people as they would like. The supply chain is struggling to meet the demands of test centers. There are not enough chemical reagents and other supplies for the tests.
“We’re at a critical juncture and the supply chain has not yet caught up,” Scott Becker, chief executive of the Association of Public Health Laboratories, told The New York Times.
What is the latest FDA-approved swab and how can it help?
Generally, healthcare workers insert a swab --which looks like a giant Q-tip -- deep into the nose or mouth to collect sputum or phlegm, a substance you produce during an infection. Many patients complain of discomfort during the process. What is worse, healthcare workers are at risk of exposure to the virus. And hospitals are running short of swab supplies too.
The new swab, developed by US Cotton with the FDA, is much shorter and more comfortable. "The type of testing at the front of the nose used in this study is notable because it allows self-collection by patients thereby limiting exposure of healthcare providers,” the FDA said in a statement.
“This action today demonstrates the ingenuity that results from FDA working in partnership with the private sector,” FDA Commissioner Stephen Hahn said in a statement. The US Cotton will now manufacture them in large numbers.
What is the saliva test?
The FDA has approved Rutgers University's saliva test for emergency use. Because users can themselves collect their saliva samples, the developers say their test will pave the way for broader population screening.
“The impact of this approval is significant,” Andrew Brooks, chief operating officer and director of technology development at the university's RUCDR Infinite Biologics lab, said in a statement.
The test is simple and lots of people can get themselves screened. “It means we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections. We can preserve precious personal protective equipment for use in patient care instead of testing," he explained.
Besides, the test is a lot comfortable than conventional swab tests. "It highlights the great innovation that we've seen around the country in response to the outbreak," Hahn said. "You can use saliva rather than the swab in the nose. It's more comfortable for the patient. It can be repeated multiple times and it's safer for the health care provider in terms of collection," he added.
A company named Vault Health is selling these tests for $150. A clinician will oversee the process via video conferencing platforms such as Zoom. Users will have to then parcel their saliva samples to the Rutgers lab for processing.
“It’s not an at-home test. It’s a physician ordered, practitioner-monitored, physician-reported test,” Jason Feldman, Vault Health’s chief executive officer, told STAT.