At-home saliva coronavirus test is easy, fast, convenient
Test developed by Branford lab gives results within a day
BRANFORD — No long lines. No swab up the nose. Test results in a little more than 24 hours.
Local company Wren Laboratories, which was formed to create blood tests to detect cancer, developed a saliva test for the coronavirus at the request of the state Department of Public Health.
Its developers say it is more convenient, easier and faster than the standard nasopharyngeal swab and can detect very low levels of the virus.
The kit is delivered by FedEx (or supplied by an employer or health department). It comes with a small funnel to collect saliva and a two-part tube that contains a stabilizing solution. The kit can then be dropped off at FedEx and the results will appear in an email by the next day or two, depending on the dropoff time.
“This test is completely designed to be done by a layman at home with complete safety and accuracy,” said Dr. Irvin Modlin, a retired professor of surgery at the Yale School of Medicine and a co-founder of Wren Labs. “It’s completely userfriendly, it’s 100 percent accurate, it takes two or three minutes to do and you’ll get the results the next day,”
With a second surge in COVID-19 cases, lines have formed outside testing sites. “The testing was actually in my mind engendering a huge epidemiological problem in itself by putting together all these people, some of whom are sick and some of whom weren’t,” Modlin said.
“The other question was how do you stop this and the answer is, make the test so it can be done by the person concerned in the comfort of his own home without any of this kind of anxiety and with the high exposure and vulnerability of going to [testing] sites, never mind the inconvenience,” he said.
Wren received an emergency use authorization from the Food and Drug Administration on Aug. 3 and began its saliva tests Oct. 20, according to Mark Kidd, cofounder and lab director. Work to develop the test began in May.
“We’re not a viral lab, so we had to learn very quickly how to isolate viruses, extract the mRNA and to develop the assays” that measure whether the coronavirus
is present in the patient’s sample, Kidd said. “We always wanted to do saliva, but the FDA put in some very stringent requirements.”
With the FDA’s approval, Wren became the first U. S. lab to offer a saliva test with its own collection device, which was designed at the University of Arizona and which is assembled by NPI/ Medical in Ansonia, part of Westfall Technik.
One challenge was to make sure the messenger RNA, known as mRNA, in the saliva sample doesn’t degrade. The stabilization fluid, called a buffer, ensures that, while neutralizing the virus itself, Modlin and Kidd said. The mRNA, which contains the virus’ genetic code, is the same protein that Pfizer and Moderna are using to develop vaccines.
When the two parts of
the tube are attached, a seal is cut to release the stabilizer and mix it with the saliva. “What that buffer does is it essentially neutralizes the virus in the saliva,” Kidd said. It may actually kill the coronavirus, but “we’re in the process of proving that experimentally,” he said.
“When it gets to the lab, it’s completely intact,” Modlin said of the mRNA. “If you have any loss of the material from the patient … you get a false negative, and a false negative is the most dangerous thing that exists.”
That’s because it creates a false sense of confidence in people and “they’re contaminating everybody, even though they’ve been told they’re OK,” Modlin said.
Since the mRNA is preserved intact, without the need for special packaging or refrigeration, there is “no chance of a false negative because the mRNA is degraded. The analysis takes place as soon as the test arrives at the lab,” Modlin said. “This is so sensitive it will pick up just a few particles.” And the patients receive results more quickly than through a standard test.
“In a pandemic, what you really want is complete accuracy of testing, complete facility of testing for the patient, and then, absolutely 100 percent, not only efficiency of the test but communication of the information to the parties concerned,” Modlin said.
The Yale School of
Public Health also has developed a saliva test, SalivaDirect, and so far has designated 49 lab sites in 23 states under its emergency use authorization. It is not yet available in a take-home kit, according to Anne Wyllie, an associate research scientist in epidemiology at the school.
“The Yale group really pushed the field forward,” Kidd said. “I think they’ve done a fantastic job.”
Wren has gotten the word out about its test by contacting health departments in New Haven County, schools and assisted-living centers in the area. The state health department is interested in using the test for children with autism, for whom a swab test is difficult. A television ad campaign is in the works. “We’re going to go local first, Connecticut and Northeast, and then we’re going to push out from there,” Kidd said.
“We’ve talked to a whole range of different companies,” he said, including a fashion company that had its staff tested before photo shoots in Aruba and Yosemite National Park. “We had a wedding party in Arizona, where the gift to the wedding party was free COVID testing. … All of them were negative,” he said.
Basketball players, health care workers and FedEx pilots are among those who have taken the test, according to Modlin.
The company also offers a Testing and Passporting System, in which an organization can have its employees test every day for a period of time, with the results logged on an app. The data also goes to the state health department.
The company has a staff of 10, but, Kidd said, “We’re starting to set up for when things start going crazy. … We’re going to have to double.” The building they occupy at 688 E. Main St. has plenty of room to expand.
The results come in an encrypted email. If they’re positive, “you’ll also get a call from me,” Kidd said. “The first thing is to let the patient know it’s positive and then to discuss what they have to do next.” That would be to quarantine, wear a mask indoors, make a telehealth appointment with a doctor and get a second test. They will also help in contact tracing, he said.
The test costs $ 150 and is covered by insurance. More information is available at wrencovidtesting.com.