Chesterton Tribune



CHS alum Michelle Volk leads Great Lakes Labs in readying C19 saliva test

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Valparaiso-based 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 us.”

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.

GLL’s comparative 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.

GLL’s saliva 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.


Posted 7/17/2020




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