Emmanuel Son, Staff Writer
As most of the world remains in lockdown and quarantine, the medical technology field has discovered a major advancement. The Food and Drug Administration (FDA) has recently approved a new testing method for coronavirus that uses saliva samples from patients. Recently, testing has involved a thin swab being placed at the nasal fossa connecting to the throat by the nasopharynx. Rather than using any form of swabs, the newly approved testing method requires a patient to spit into a cup.
The testing method was discovered by researchers at Rutgers University, and has caught the eyes of the White House coronavirus task force. This discovery also comes around the same time President Donald Trump has ceased to provide funding to the World Health Organization (WHO). Rutgers University states that this testing method could lead to an increase in tests by up to 10,000 a day, CNBC reports.
Improvements for this method of testing include a more comfortable instruction for the patient and makes it safer for health care workers. More protective gear can go towards hospital workers now rather than those handling tests. It should be noted that tests cannot be sent home to patients. Those who will be tested still have to be present physically with a healthcare professional.
However, FDA Commissioner, Stephen Hahn M.D., confirmed in an interview with Fox News that the new tests are a highlight of innovation when responding to the virus: “It’s more comfortable for the patient. Obviously, it can be repeated multiple times and it’s actually safer for the health care provider in terms of collection.”
Another medical professional, Devi Nampiaparampil, M.D., points out that right now, workers performing tests come into close contact with patients when swabbing. This would then require workers to change gear, such as gloves or garment after each patient. Because saliva testing does not require close contact, workers no longer have to change garments after each patient.
Rutgers University partnered with New Jersey based healthcare provider, RWJBarnabas, to establish a drive-thru testing center for residents of Edison, N.J., which started on April 15.
Test kits can be purchased from New York based company Vault Health for $150. Rutgers professor and director of technology development of biologics, Andrew Brooks, told Fox News that this form of testing at drive-thrus can get ten cars going through every two or three minutes to collect samples.
While the new test kits have been praised by many as an imperative advancement, some are now questioning whether the new test kits are too good to be true. A common concern brought up is whether saliva holds enough evidence of the virus. But Microbiologists have said that saliva should be enough to determine whether a patient is positive. Brooks stated that he feels confident about the test and has White House support, with President Trump calling it “innovation under pressure.”
Another convincing argument for the new tests Brooks uses are his practices. Brooks is the chief scientist of Spectrum USA. Spectrum USA provides DNA collecting kits to Ancstery.com. Those same test tubes that involve saliva for DNA tests can collect the needed RNA sample to determine if coronavirus patients have been exposed. That leaves the question of whether genealogy testing companies can test patients for the virus. Firms such as Ancestery.com and 23 and Me have taken into consideration using their business in saliva testing to develop practicable test kits.
Ancestery.com Chief Scientific Officer Catherine Ball, M.D., has stated that the company has already sent out its test kits with independent labs in the US. The company is currently conducting experiments into whether or not their own devices can support COVID testing. According to ABC news, a spokesperson for 23 and Me stated that the company has explored its options for bringing saliva diagnostic test kits to market, but claims that there are many roadblocks the company must go through first, indicating that it will not be any time soon. The spokesperson claimed the problem faced right now is that the company’s test kits focus highly on gathering DNA, rather than RNA. The company continues to look for ways to donate supplies needed for proper test kits, but faces the challenge that many of their suppliers are operating with minimal staff.
While the FDA has authorized the use of saliva tests, there are still many questions about whether at-home tests will become available in the near future. The FDA has stated on their website that, “At this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19.”
The FDA has also stated that they are working with test developers on the availability of expanding coronavirus test kits that may include at-home testing. While the FDA has not approved at-home testing, many companies have already encouraged saliva testing as a safer method that does not require close contact or much protective gear.
CEO of BioIQ, Justin Bellante, stated, “Our goal is getting capacity to front line healthcare workers.” While Vault has been doing at-home testing with patients through telehealth which was said to have met the requirement of a present physician, the FDA had updated their website stating it has not offered any at home testing, “including self-collection of a specimen with or without the use of telemedicine.”
Proponents of telemedicine hope that the FDA will see the importance of distributing at-home saliva kits is worth more than any setbacks of safety or reliability. Stanford-trained obstetrician Ruth Ann Crystal, M.D., who works with medical technology, argues that while the FDA has rules for safety the coronavirus is a major problem and that being able to test at home would be huge.
John Brownstein, M.D., of Boston’s Children Hospital said, “If the saliva test performs well, I see no reason why conducting them over telemedicine would not work well.”
Brownstein does note that there are concerns regarding reliability of remote testing. Andrew Brooks has responded to concerns and critics, saying the test should only take two minutes. “You spit in a tube, put the cap back on, and you’re on your way.”