RESEARCH TRIANGLE PARK – The first-ever point-of-care instrument for qualitatively detecting fentanyl in human urine has been cleared for use by the U.S. Food Drug Administration and will be distributed in the United States by a Greensboro-based company.

Carolina Liquid Chemistries Corp., a provider of chemistry analyzers and reagents for drug testing and general chemistry testing for over 25 years, will distribute the instrument and fentanyl urine detection kit in partnership with Bioeasy USA of La Verne, Calif.

“We are very proud of the work that our partner Bioeasy and its consultants have done to bring this product to market,” said Patricia Shugart, chief operating officer of Carolina Liquid Chemistries. “Physicians can have results in under six minutes. This is a game changer.”

The test kit is a fluorescence immunoassay for the detection of fentanyl in urine at a cutoff concentration of 1.0 nanograms per milliliter.

“To achieve as low as a 1ng/ml cutoff is very challenging, and I’m very proud that our R&D team made a great technical breakthrough,” said Elaine Zhang, general manager of Bioeasy USA.

The assay is intended for use with Carolina Liquid Chemistries’ portable immunofluorescence analyzer, brand-named RYAN.

The analyzer, measuring 11 inches wide and 11 inches deep and weighing just over four pounds, can be used in a laboratory or point-of-care setting.

Automated results come within six minutes. A more specific alternative chemical method must be used to confirm an analytical result.

Fentanyl is a potent pain reliever that is up to 50 times stronger than heroin and 100 times stronger than morphine. It can become addictive with prolonged use, and even small amounts of pharmaceutical fentanyl or illicitly made fentanyl for recreational use can lead to dangerous overdoses.

More than 150 people die every day from overdoses of fentanyl and other synthetic opioids, according to the National Center for Health Statistics.

“Now that the abuse of fentanyl has been causing serious problems, I deeply hope this product can help to fight the drug threat in the USA,” Zhang said.

Bioeasy USA is a wholly owned subsidiary of Shenzhen Superbio Technology Co. of Shenzhen, China. It provides comprehensive drug-testing products for the U.S. toxicology market, including panels for popular drugs of abuse such as fentanyl, oxycodone, tramadol, K2, gabapentin and more.

Carolina Liquid Chemistries, founded in 1994, is a veteran-owned, ISO-certified, FDA-registered manufacturer, re-packager, re-labeler and value-added reseller of chemistry systems and reagents for use in reference laboratories and clinical laboratories in hospitals, physician offices and veterinary facilities. The company has a reagent production facility in Brea, Calif.

“With companies like Carolina Liquid Chemistries, the Piedmont Triad continues to be an important contributor to strengthening North Carolina’s leadership as the largest global concentration of contract research & testing organizations,” said Nancy Johnston, executive director of the North Carolina Biotechnology Center’s Piedmont Triad Office.

(C) N.C. Biotech Center