Quidel has received 510(k) clearance from the FDA to market the Quidel Triage® TOX Drug Screen, 94600, a fluorescence immunoassay for the determination of the presence of drugs and/or metabolites in human urine. The test is to be used with Quidel’s Triage® MeterPro instrumented system.
Drug abuse in the U.S. continues to be a major social and economic problem. Opiates, cocaine, THC, and amphetamines are recognized by the Substance Abuse and Mental Health Services Administration (SAMHSA) as the most commonly abused illegal drugs. Prescription drugs such as benzodiazepines, tricyclic antidepressants, barbiturates, and opiate compounds are also frequently abused.
Urine-specific screening tests for drugs range from simple immunoassay tests to complex analytical procedures. But the speed and sensitivity of immunoassays have made them the preferred method for detecting drugs in urine.
The TOX Drug Screen, 94600 uses distinct immunoassays to simultaneously detect drug and/or urinary metabolites of as many as nine different drug classes. Using monoclonal antibodies that are specific for the metabolites of these drug classes ensures a high level of sensitivity and specificity.
Approximately 15 minutes after the specimen is added, the Quidel Triage MeterPro screen displays results, which are stored in the system’s memory to display or print when needed. The results can also be transmitted to the laboratory or hospital information system.
Source: Seeking Alpha, June 19, 2019