News and Updates
Carolina Liquid Chemistries Launches Fentanyl Test
First Benchtop Clinical Chemistry Analyzer to offer a Moderately Complex Norfentanyl Test
GREENSBORO, NC — (March 17, 2020) — Carolina Liquid Chemistries, Corp. (CLC), an innovative leader in clinical diagnostics and drug screening, has received FDA/CLIA Moderate Complexity categorization for Norfentanyl on Medica Corporation’s EasyRA® clinical chemistry analyzer. As the first moderately complex norfentanyl test available on a small benchtop analyzer, this breakthrough now makes fentanyl testing available to a wider range of clinical laboratories.
The Carolina Liquid Chemistries Fentanyl Enzyme Immunoassay (FENT) is intended for the qualitative determination of norfentanyl in human urine at the cutoff value of 5ng/mL when calibrated against norfentanyl. Norfentanyl is the major metabolite of fentanyl. Due to its short elimination half-life and approximately 90% metabolism, fentanyl itself can be difficult to detect in urine (1). In an intravenous dose of fentanyl, up to 85% is excreted in urine over a 3– to 4– day period with 0.4 – 6% eliminated as unchanged fentanyl and 26 – 55% eliminated as the norfentanyl metabolite (2).
“Unlike other fentanyl assays on the market that are calibrated directly to fentanyl, this assay is calibrated directly to norfentanyl, while still cross-reacting to fentanyl at 156.25%. This allows laboratories to identify more true positives,” says Philip Shugart, CEO of Carolina Liquid Chemistries.
Fentanyl is an important opioid analgesic used widely in surgery and is a controlled substance (3). Fentanyl is most commonly encountered in patches applied to the skin, as “lollipops” dissolved in the mouth, or administered intravenously. It is 50-100 times stronger than morphine (4, 5), and fentanyl abuse via injection, inhalation, oral, or nasal applications have been reported (6). Fentanyl is used in the treatment of acute and chronic pain, usually in patients who no longer respond to high doses of less potent opioids such as morphine or oxycodone. Due to its potency and wide availability as a prescribed drug, fentanyl has been abused and misused (7).
This breakthrough adds to the already comprehensive drug screening menu offered by Carolina Liquid Chemistries on the Medica EasyRA clinical chemistry analyzer. The norfentanyl assay can be paired with other CLIA moderately complex assays for amphetamines, barbiturates, buprenorphine, benzodiazepines, cannabinoid, cocaine, ethanol, MDMA, methadone, opiates, oxycodone, phencyclidine, and propoxyphene. Additionally, the EasyRA clinical chemistry analyzer offers a comprehensive general chemistry menu.
The EasyRA clinical chemistry analyzer is a small, cost-effective, easy-to-use and maintain system that can perform up to 300 photometric tests per hour. It is well suited for a variety of clinical laboratories located in physicians’ offices, urgent care centers, satellite laboratories, pain management clinics, toxicology laboratories, emergency rooms, and rural hospitals.
About Carolina Liquid Chemistries Corp.
Headquartered in Greensboro, NC, Carolina Liquid Chemistries is a ISO 13485:2016 certified manufacturer, repackager/relabeler, distributor, and technical service provider of chemistry systems and reagents for clinical and toxicology laboratories. The company offers chemistry analyzers that range in throughput from 300 to 6,400 tests per hour and markets a wide menu of general chemistry, special chemistry, and toxicology reagents, along with affordable service contracts. For more information, visit carolinachemistries.com or email [email protected].
- McClain DA, Hug CC Jr., Intravenous fentanyl kinetics. Clin Pharmacol Ther 28:106-114 (1980).
- Baselt R.C., Disposition of Toxic Drugs and Chemicals in Man, 10th edition. Biomedical Publications: Seal Beach, California; 846–849 (2014).
- Ikeda R., Pelton C. Diversion programs for impaired physicians. West J Med, 152: 617-621 (1990).
- Poklis A., Fentanyl: a review for clinical and analytical toxicologists. Clinical Toxicology, 33, 439–447 (1995).
- Jaffe J.H., Martin W.R., Opioid analgesics and antagonists. In: Pharrnacological Basis of Therapeutics, 7th Ed. Gilman AG, Goodman LS, Rall TW, Murad F, eds. New York: MacMillian, 517 (1985).
- Ellenhorn M.D., Schonwald S., Ordog G., Wasserberger J, Fentanyl, in: Ellenhorns Medical Toxicology, Williams & Wilkins, Baltimore, Philadelphia, London, Paris, Bangkok, Buenos Aires, Hong Kong, Munich, Sydney, Tokyo, Wroclaw, 416–420 (1997).
- Atluri S., Sudarshan G., Manchikanti L., Assessment of the trends in medical use and misuse of opioid analgesics from 2004 to 2011. Pain Physician, 17, E119–E128 (2014).
CLC Norfentanyl Press Release.00 MAR 2020
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