Ortho-Clinical Diagnostics, a Johnson & Johnson company, announces FDA 510(k) clearance and worldwide availability of five additional MicroTip™ assays for use in the diagnosis and treatment of drug use or overdose. The five new tests complete the menu of eight drugs-of-abuse assays now available for use on the Ortho-Clinical Diagnostics VITROS® 5,1 FS Chemistry System. These assays are used to detect the presence in urine of the following substances:
Barbiturates (BARB)
Benzodiazepines (BENZ)
Cannabinoids (THC)
Methadone (METD)
Opiates (OP)
Barbiturates, also known as "downers," are sedative hypnotics with central nervous system depressant activity. Benzodiazepines are prescribed for the treatment of anxiety or panic disorder, and as a sleeping aid, anticonvulsant or muscle relaxant. They also can be used as hypnotics. Cannabinoids from the marijuana plant produce a variety of pharmacological effects including sedation, euphoria, hallucinations, memory and learning impairment and temporal distortion. Methadone is a synthetic opioid drug with narcotic/analgesic properties that are similar to morphine. It is used in the treatment of opioid addiction and in the management of chronic pain. Opiates are alkaloid compounds that are derived naturally from the poppy plant. Morphine, codeine, and heroin are the most common opiates.
Drug abuse is a major problem around the world. The World Health Organization estimates that some 200,000 people died because of drug abuse in the year 2000, equivalent to 0.4 percent of all deaths worldwide.1 In the U.S. alone, there were an estimated two million drug-related emergency room visits in 2004.2 Substance abuse puts a significant financial burden on the health care system every year. It is estimated that in 2000, drug abuse in the U.S. represented nearly $13 billion in health care costs.3
The VITROS® 5,1 FS Chemistry System allows the consolidation of drugs of abuse testing (DAT) with routine chemistry testing on a single platform. In addition to the five new DAT assays, the VITROS® 5,1 FS DAT menu includes amphetamines, cocaine metabolites and phencyclidine.
These latest product launches increase the MicroTip™ assay menu that Ortho-Clinical Diagnostics has introduced for use on the VITROS® 5,1 FS Chemistry System since October 2004 to a total of 34 new assays. VITROS® MicroTip™ technology provides an extended menu of proteins, therapeutic drugs, cardiac, diabetes and other critical assays. MicroTip™ technology is unique in that assays are processed using single-use tips and cuvettes, which eliminates sample and reagent carryover. In addition, MicroTip™ technology reduces the maintenance associated with other wet chemistry analyzers. Costs associated with water, plumbing, fixed probes, mixing assemblies, liquid waste management and compliance with local waste disposal regulations are minimized.
About Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics, a Johnson & Johnson company, is a leading provider of high-value diagnostic solutions for the global health care community. Committed to developing the most advanced tests for early detection or diagnosis of disease, the company brings products to market that provide timely information and help to facilitate better medical decisions. Ortho-Clinical Diagnostics also provides blood screening and typing products that help to ensure the safety of the world's blood supply. In addition, through its VITROS® MicroSlide™ and enhanced chemiluminescence technologies, the company has transformed the way that clinical laboratories perform testing. Worldwide, health care professionals rely on Ortho-Clinical Diagnostics for innovative diagnostic solutions and services that promote effective diagnoses and enhance patient care. For more information, visit orthoclinical.
1. United Nations Information Service
2. DAWNinfo.samhsa/
3. National Institute on Drug Abuse
Ortho-Clinical Diagnostics
orthoclinical
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