Quidel (QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced that Quidel has received 510(k) clearance from the Unites States Food and Drug Administration (FDA) to market the Quidel Triage® TOX Drug Screen, 94600, a fluorescence immunoassay for the qualitative determination of the presence of drug and/or metabolites in human urine of up to 9 drug assays. The test is to be used with Quidel’s Triage® MeterPro instrumented system.
Drug abuse in the United States continues to be an increasingly significant social and economic problem. Opiates, cocaine, THC and amphetamines are recognized by the Substance Abuse and Mental Health Services Administration (SAMHSA) as the most frequently abused illicit drugs. Benzodiazepines, tricyclic antidepressants, barbiturates and opiate compounds are among a prescription drugs that also are frequently abused.
Urine-specific screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most accepted method for screening urine for the presence of drugs.
The Quidel Triage TOX Drug Screen, 94600 uses distinct immunoassays for the simultaneous detection of drug and/or the urinary metabolites of up to 9 different drug classes. The use of monoclonal antibodies that are specific for the metabolites of the 9 drug classes ensures a high degree of sensitivity and specificity. The positive or negative results are typically displayed on the Quidel Triage MeterPro screen in approximately 15 minutes from the addition of specimen. All results are stored in the Meter memory to display or print when needed. If connected, the Meter can transmit results to the laboratory or hospital information system.
“We believe that our latest diagnostic screening test can play an important role in providing fast, diagnostic answers to healthcare providers in the emergency and urgent care settings,” said Douglas Bryant, president and chief executive officer of Quidel. “We are very pleased to receive clearance from the FDA for our Quidel Triage TOX Drug Screen, 94600 toxicology test and are optimistic that this assay will drive growth in the Triage business by delivering a more reliable, higher quality product to the customer, as well as creating further growth in the installed base of MeterPro instruments out in the field.”