Carolina Liquid Chemistries, Greensboro, NC, has received an FDA/CLIA moderate complexity categorization for its norfentanyl test, performed on the EasyRA clinical chemistry analyzer from Medica, Bedford, Mass.
As the first moderate complexity norfentanyl test available on a small benchtop analyzer, the test makes fentanyl testing available to a wider range of clinical laboratories.
The Carolina Liquid Chemistries’ fentanyl enzyme immunoassay is intended for the qualitative determination of norfentanyl in human urine at the cutoff value of 5 ng/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. In an intravenous dose of fentanyl, up to 85% is excreted in urine over a 3- to 4-day period, with 0.4% to 6% eliminated as unchanged fentanyl and 26% to 55% eliminated as the norfentanyl metabolite.
“Unlike other fentanyl assays on the market that are calibrated directly to fentanyl, this assay is calibrated directly to norfentanyl, while still crossreacting to fentanyl at 156.25%,” says Philip Shugart, CEO of Carolina Liquid Chemistries. “This allows laboratories to identify more true positives.”
For more information, visit Carolina Liquid Chemistries.