GREENSBORO – Carolina Liquid Chemistries – a Greensboro diagnostics and drug screening company – has introduced two new immunoassays to test for COVID-19 and for norfentanyl, the major metabolite of the synthetic opioid pain reliever fentanyl.
The company says its ALLTest Rapid Screen Antibody Test Cassette will check for the presence of the IgG and IgM antibodies to COVID-19 in whole blood, serum or plasma samples. The chromatographic immunoassay falls under new U.S. Food and Drug Administration guidelines for coronavirus testing during a public health crisis.
Since the Rapid Test Cassette only targets IgG and IgM, the company said it should not be the sole criterion for diagnosing coronavirus. Negative results don’t rule out infection. So patients should consider follow-up testing with another diagnostic, particularly if they’ve been in close contact with someone who has COVID-19.
“These are unprecedented times,” said Phillip Shugart, CEO of Carolina Liquid Chemistries (CLC). “The rapid screen is a fast and easy screen for antibodies that complements other tests and symptoms to give a fuller picture.”
CLC also announced that it has received the Center for Medicare and Medicaid Services’ CLIA (Clinical Laboratory Improvement Amendments) moderate complexity classification for its Fentanyl Enzyme Immunoassay.
The company said it can qualitatively screen for the norfentanyl metabolite of fentanyl on a benchtop EasyRA clinical chemistry analyzer brought to market through a partnership with the Medica Corporation. The small analyzer can run 300 tests an hour. CLC said the moderate complexity classification, the first for norfentanyl on this type of equipment, allows many more clinical labs to run the immunoassay.
The test detects norfentanyl in urine as a way to gauge the presence of fentanyl, an opioid used for acute and chronic pain and abused with increasing frequency.
The test can determine if patients are taking their medications as prescribed, and if fentanyl is being used inappropriately. Since the norfentanyl metabolite remains in the body longer than fentanyl, CLC said it can provide a more effective way to test for the drug.
The company said the EasyRA analyzer can pair the norfentanyl qualitative screen with a number of other CLIA moderately complex drug tests. It also offers a comprehensive general chemistry menu.
CLC sells its diagnostics and drug screening tools and reagents (test kits) to clinical and toxicology labs across the county. It offers a variety of chemical analyzers for all types of clinical settings.
The business was founded in 1994 by Phil Shugart, a native North Carolinian who began his career with medical device manufacturers Coulter Electronics and Beckman Instruments. His wife, Patricia – a medical technologist – is CLC’s chief operating officer. The company has more than 40 employees.
Phil Shugart received the North Carolina Biotechnology Center’s Entrepreneur of the Year award in 2014.