Shenzhen Superbio Technology has received clearance from the U.S. Food and Drug Administration (FDA) for its point-of-care instrument intended for qualitative detection of fentanyl in human urine and has fully released authorization to Bioeasy USA of this product in the U.S.

Carolina Liquid Chemistries Corp., a provider of chemistry analyzers and reagents for drug testing and general chemistry testing, has partnered with Bioeasy and will be the distributor of the product in the U.S. under the brand name RYAN, the company says.

The Carolina Liquid Chemistries Corp. Fentanyl Urine Detection Kit is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Carolina Liquid Chemistries Corp. immunofluorescence analyzer RYAN. The test provides a preliminary test result; a more specific alternative chemical method must be used in order to obtain a confirmed analytical result.

The Carolina Liquid Chemistries Corp. immunofluorescence analyzer RYAN is a portable fluorescence instrument for in vitro diagnostic use only. The analyzer is designed to perform in vitro diagnostic tests on clinical urine specimens. This analyzer can be used in a laboratory or in a point-of-care setting.

Fentanyl is a potent narcotic analgesic and is a kind of special opioid receptor excitant. Fentanyl is one of the varieties under the supervision of the United Nations Single Convention on Narcotic Drugs of 1961. Fentanyl is one of the most common drugs used for treating moderate and severe pain. After continuous injections with fentanyl, patients will have symptoms of opioid withdrawal syndrome such as ataxia and testiness. Patients that have taken fentanyl for a long time may become addicted. Fentanyl is mainly transformed biologically in the liver and forms various metabolic products without pharmacological activity. About 75% of these metabolic products are excreted with urine, about 10% are excreted with urine in original form, and a few are excreted with feces and bile.

“We are very proud of the work that our partner Bioeasy and its consultants have done to bring this product to market,” says Paticia Shugart, COO of Carolina Liquid Chemistries Corp. “Physicians can have results in under 6 minutes. This is a game changer.”

The RYAN analyzer with the Carolina Liquid Chemistries Corp. Fentanyl Urine Detection Kit uses the principle of competitive and fluorescence immunochromatography assay and uses fluorescence microspheres-labeled monoclonal antibody as the indicator marker to qualitatively detect fentanyl in human urine.

“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,” says Elaine Zhang, general manager of Bioeasy USA.

Photo: Carolina Liquid Chemistries Corp.