Hydrocodone assay wins FDA approval

A NEW immunoassay specifically for the detection of hydrocodone has been granted regulatory approval in the USA.

The DRI Hydrocodone Assay from Thermo Fisher Scientific is a homogeneous enzyme immunoassay, and has received 510 (k) clearance from the US Food and Drug Administration (FDA).

The company says the assay also meets the recently-proposed Substance Abuse and Mental Health Administration (SAMHSA) guidelines.

SAMHSA oversees the testing of federally-regulated employees, and the guidelines are also followed by other employers.

Hydrocodone is a semi-synthetic opioid drug, used as a cough suppressant and narcotic analgesic for the treatment of pain.

It is one of the most frequently prescribed and misused opiate drugs in the USA, and is available under hundreds of different brand names and in various combinations with other hydrocodone products.

The DRI Hydrocodone Assay is said to have excellent cross-reactivity to the major metabolites hydromorphone and hydromorphone-glucuronide.

Thermo says the assay demonstrates good correlation with LC-MS/MS and has excellent specificity and sensitivity, making it useful screening tool for hydrocodone in urine samples.


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