New FDA-Cleared Oral Fluid Testing Kits Join Thermo Fisher Scientific Reagents and Quest Diagnostics Oral-Eze Patented Collection Technology

Thermo Fisher Scientific Inc. today announced U.S. Food and Drug Administration clearance and launch of six new Thermo Scientific Oral Fluid Drugs of Abuse immunoassays that 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. The company will showcase the products at Thermo Scientific booth #1720 during Clinical Lab Expo at AACC 2011, being held July 26 – July 28, at the Georgia World Congress Center, Atlanta, Georgia.

Oral fluid tests (OFT) for drugs of abuse offer a valuable alternative to traditional urine sample testing. Collection is observed and non-invasive, 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, proven 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 percent 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.

For more information about Thermo Scientific reagents, please visit booth #1720 during AACC 2011 or visit the company article page.