The FDA has granted clearance to six new oral fluid drugs of abuse immunoassays from Thermo Fisher Scientific Inc. The immunoassays test for amphetamines, cannabinoids (THC), cocaine, methamphetamines, opiates, and PCP. The Thermo Scientific reagents complement the patented Oral-Eze oral fluid specimen collection device from Quest Diagnostics. The immunoassays and specimen collection device are available for in vitro diagnostics use. Oral fluid tests (OFT) for drugs of abuse offer a valuable alternative to traditional urine sample testing. Collection is observed and noninvasive, reducing the risk of adulterated samples. Samples can be collected during routine field visits or regular check-ins, eliminating the need for laboratory collection. These qualitative tests are used as screening tools to aid in the investigation of drug use. As with any drug screening, confirmation testing is required.
Accompanying the immunoassays are oral fluid calibrators and control sets. Analyte-specific calibrators and control sets are available for the cannabinoids OFT and the methamphetamine OFT kits, while multi-drug OFT calibrators and multi-drug control set support amphetamine, cocaine, opiate, and PCP oral fluid immunoassays.
While they use the same cloned enzyme donor immunoassay technology as urine drug monitoring products, these new oral fluids assays, calibrators, and control sets introduce new options in drug screening. Kits are available in a range of sizes to meet specific test volume needs. Calibrators are liquid, ready-to-use and offer three-point calibration: negative, cut-off and high. The Oral Fluid Control Set is packaged with low and high control at ±50% of cut-off and can be used with any reagent lot. Oral fluid screening is now faster and more cost-effective using the clinical chemistry analyzers, such as the MGC 240 bench top analyzer or other chemistry analyzers for larger test volumes. Applications on a variety of chemistry analyzers are also available.