25 June 2019 - - US-based diagnostics company Quidel Corp. (NASDAQ: QDEL) has received 510(k) clearance from the Unites States Food and Drug Administration 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 nine drug assays, the company said.
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 recognised 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 group of 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 nine different drug classes. The use of monoclonal antibodies that are specific for the metabolites of the nine 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.
Quidel develops diagnostic solutions. Marketed under the Sofia, QuickVue, D3 Direct Detection, Thyretain, Triage and InflammaDry leading brand names, as well as under the new Solana, AmpliVue and Lyra molecular diagnostic brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood.