Great Lakes Labs (GLL) is poised to be the first place in the Region to
offer a COVID-19 test that utilizes a saliva sample since it completed a
comparative study of test effectiveness and ordered 5,760 SDNA-1000s, a
United States Food and Drug Administration-approved collection device.
According to GLL
President and CEO Michelle Volk, saliva testing for COVID-19 was most
notably developed and vetted by Rutgers University’s Clinical Genomics
Laboratory earlier this year. “When I read about what Rutgers was doing, I
decided it was time for Great Lakes Labs to get involved,” Volk said. “Some
of our positive cases were generous enough to participate in a study with
GLL has worked
primarily on DNA and toxicology testing since Volk opened it in 2003, but as
a United States Department of Health and Human Services-certified high
complexity lab, it is authorized to use a PCR RNA analysis to test both
nasopharyngeal and saliva samples for COVID-19, Volk said.
Volk said the nasal
swab test those who have been tested are familiar with, the nasopharyngeal
method, is the ‘gold standard’ for testing for upper respiratory infections,
but GLL’s own validation study showed that testing saliva produces
comparable results, in line with Rutgers Clinical Genomics labs research.
analysis of about 50 samples from patients who tested positive using the
nasopharyngeal test and rigorous testing of how a synthetic version of the
virus progresses when tested over a span of days and at different times
during the day showed that GLL achieves the same 99 percent level of
reliability from testing nasopharyngeal samples and saliva samples,
according to Volk.
Volk said saliva
testing is “one more alternative for our country to offer testing at a much
higher rate,” and an alternative to the discomfort some experience with the
nasal swab. The SNDA-1000 also makes a test more accessible by giving
patients the option to collect their samples at home, she said.
testing will be available by Aug. 1 and comparable in price to its nasal
swab testing. Volk demonstrated that self-collecting a saliva sample takes
mere minutes in an interview with the Chesterton Tribune this
morning. Patients must abstain from eating or drinking and should not brush
their teeth 30 minutes prior to self-collecting. The sample has a shelf-life
of 10 to 14 days at room temperatureÐÐthree times that of a nasal swabÐÐdue
to a proprietary stabilizing buffer that is activated when a patient closes
the sample container.
If GLL collects or
receives a sample at 9 a.m., for example, Volk says the patient will get
results after 4 p.m. the next day. When ready for testing, the sample is put
onto a ‘biochip’, smaller than a credit card that holds 96 samples. The
virus is detected, or not detected, in a patient’s RNA using real time
polymerase chain reaction (RT-PCR) methodology.
Volk said GLL
started offering COVID-19 tests to help the community. “We had the
personnel, we had the equipment, and we had the need,” Volk said. “National
labs are inundated. We’re a regional lab, and as a regional lab, we want to
support our local community.”
GLL has been doing
50 to 100 nasal swab tests a day, with the average person paying between
$105 and $165. A doctor’s order is not required, and a lot of the patients
are first responders and essential workers, according to Volk. She said
scientists don’t usually know the impact of their testing, but GLL has been
getting positive feedback. “It’s so gratifying to be able to help the people
you’re shopping next to or sitting next to at a baseball game.”
Volk is a graduate
of Chesterton High School and Purdue University. She has a bachelor’s degree
in political science and criminology and trained under a board-certified
toxicologist, working her way up from being an evidence clerk to the
director of operations at a toxicology lab in Hobart. She also worked at a
national toxicology lab before she opened GLL in 2003. Now, GLL is like its
own little community, she said, including lab dog Gerti the black lab.
“I come from a long
line of first responders and law enforcement. I think that’s why it’s near
and dear to me to make sure the resources we offer are going to keep our
community safe,” Volk said.