News and Updates
First Ever Point-of-Care Instrument to Test for Fentanyl Receives FDA Clearance
Greensboro, NC (March 8, 2023) – Shenzhen Superbio Technology Co., LTD. (Superbio) has received clearance from the US Food and Drug Administration (FDA) on the first ever point-of-care instrument intended for qualitative detection of fentanyl in human urine and has fully released authorization to Bioeasy USA, Inc.(Bioeasy) of this product in the United States of America. Carolina Liquid Chemistries Corp. (CLC), a leading provider of chemistry analyzers and reagents for drug testing and general chemistry testing for over 25 years, has partnered with Bioeasy and will be the distributor of the product in the USA under the brand name RYAN™.
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.
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.
“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.”
“To achieve as low as a 1ng/ml cutoff is very challenging, and I’m very pround that our R&D team made a great technical breakthrough,” says Elaine Zhang, the General Manager of Bioeasy USA. Ms. Zhang continued, “Now that the abuse of Fentanyl use has been causing serious problems, I deeply hope this product can help to fight the drug threat in the USA!”
To learn more about the products and services offered by Carolina Liquid Chemistries Corp. including clinical chemistry analyzers, general chemistry, special chemistry, drug testing reagents, and COVID-19 test kits and supplies please visit carolinachemistries.com.
About Carolina Liquid Chemistries Corp.
Carolina Liquid Chemistries Corp. (CLC), a certified Veteran Owned Business headquartered in Greensboro, NC, has its reagent production facility located in Brea, CA. This ISO certified facility is an FDA registered, manufacturer, re-packager, re-labeler, and value-added reseller of chemistry systems and reagents for general chemistries and urine drug tests. CLC helps clinical laboratories of all sizes reduce chemistry analyzer and reagent costs while also receiving accurate and timely results. The company has responded to the COVID-19 pandemic by providing various testing products and supplies to market under the FDA’s Emergency Use Authorization. For more information, call 877-722-8910 x103, visit carolinachemistries.com, or email [email protected].
About Bioeasy USA, Inc.
Bioeasy USA, Inc, located in La Verne, CA, is a wholly-owned subsidiary of Shenzhen Bioeasy Biotechnology Co., Ltd (Stock Code: 300942), who is dedicated to R&D, manufacturing and sales & marketing of POCT IVD products ranging from lateral flow rapid testing to POCT Chemiluminecense (CLIA)products for years. Bioeasy USA focuses on toxicology market in US, providing comprehensive drug testing portfolio covering instant urine/oral fluid testing solutions. With a wide range of drug panels, including the popular drugs of fentanyl, oxycodone, tramadol, K2, gabapentin and more, Bioeasy USA DOA products can widely serve different practice segaments.
- Carolina Liquid Chemistries Now Offers K-ASSAY® CLIA Moderate Complexity Microalbumin Reagent for Use on the Medica EasyRA® Benchtop Clinical Chemistry Analyzer
- CLC Newsletter – Nov 2023
- Drug Screening Assays Now Available on the Diazyme DZ-Lite™ c270 Benchtop Clinical Chemistry Analyzer
- The Mission of Our Newsletter
- First Ever Point-of-Care Instrument to Test for Fentanyl Receives FDA Clearance
- View All Products
- Floor Model Chemistry Analyzers
- Benchtop Chemistry Analyzers
- Reagents for Chemistry Analyzers
- Fentanyl Urine Detection Kit on CLC RYAN Analyzer
- Personal Protective Equipment
- Coronavirus (COVID-19) Tests
- POC & Rapid Diagnostic Tests
- Infectious Disease Rapid Tests
- Immunoassay Analyzers
- Hematology Analyzers
- Veterinary Analyzers
- Warehouse Clearance
- Service, Tech Support, Customer Training
- For Customers