Triage TOX Drug Screen
Produces 11 drugs-of-abuse results simultaneously
The Triage TOX drug screen from Biosite Inc, San Diego, an Inverness Medical company, uses fluorescence-immunoassay technology to produce 11 drugs-of-abuse results simultaneously in approximately 15 minutes—including a qualitative urine assay for acetaminophen. Each test device contains multiple, on-board controls that are performed automatically to ensure acceptable performance. The company provides support to interface Triage meters to most data-management systems. The meters process assays for BNP, CK-MB, myoglobin, troponin I, and d-Dimer. The products, for use in the lab or at the point of care, provide rapid results and may help drive improved efficiencies and cost-effectiveness. The meter and drug screen are FDA 510(k) cleared for commercial distribution.
Drugs-of-Abuse Urine Screen Controls
Monitors performance of drugs-of-abuse screening methods
Drugs-of-abuse urine screen controls from Quantimetrix Corp, Redondo Beach, Calif, monitor the performance of Abuscreen ONLINE®, AxSYM®, EMIT®, Triage®, and other drugs-of-abuse screening methods. Newly added to the drugs-of-abuse control are codeine, LSD, MDA, MDMA, and MDEA. The product is liquid, human urine-based, and has a 3-year unopened and open-vial stability when stored at 2°C to 8°C (from date of manufacture). The control meets current revised guidelines established by the Substance Abuse and Mental Health Services Administration. Level 1 is drug-free urine. Level 2 has drug analytes below screening-cutoff levels (negative-threshold screen). Level 3 is designed to contain drug analytes above screening-cutoff levels (positive screen).
DRI Tricyclics Serum Tox Assay
Determines amount of tricyclic antidepressants in human serum
The new DRI® Tricyclics Serum Tox assay from Beckman Coulter Inc, Fullerton, Calif, is for the qualitative and semiquantitative determination of tricyclic antidepressants in human serum or plasma. A widely used treatment for depression, tricyclics have become the most common drug-overdose cases admitted to intensive care units. Acute toxicity due to tricyclic antidepressants may lead to coma, cardiac arrhythmia, respiratory depression, and death. The panel includes the DRI Barbiturate Serum Tox assay and the DRI Benzodiazepine Serum Tox assay. The assay leads a panel of serum-tox assays available from the company. The assays are manufactured by Thermo Fisher Scientific and are distributed by Beckman Coulter as part of its menu of automated-chemistry assays for the UniCel® DxC or Synchron® CX and LX clinical systems. DRI is a registered trademark of Thermo Fischer Scientific Corp.
Beckman Coulter Inc
Evidence and Evidence Investigator Analyzers
Biochip Array technology
The new Biochip Array technology from Randox Laboratories Ltd, Oceanside, Calif, is an immunoassay technology to screen drugs of abuse using EIA principles. The technology detects an array of drugs in a range of clinical and forensic matrices with the sensitivity of chemiluminescence. Rather than binding antibodies into the well of a microtitre plate, the company immobilizes assays on the surface of the biochip at separate and discrete X/Y coordinates, which allows for simultaneous multianalyte testing from a single, undivided sample and reduces time, effort, and energy involved in running successive single-analyte tests. The company has created two analyzers that use the technology: Evidence is a high-throughput, fully automated system; Evidence Investigator is a small, semiautomated benchtop system.
Randox Laboratories Ltd
Menu from Carolina Chemistries for Beckman analyzers
The test menu from Carolina Chemistries, Brea, Calif—for use on Beckman Coulter analyzers—includes oxycodone, cocaine, methodone, THC, opiates, benzodiaczepine, amphetamine, PCP, propoxaphene, barbiturates, alcohol, cotinine, Ecstasy, salicylates, and acetaminophen. These reagents are also compatible with Roche Modular, Bayer, Olympus Advia, and Abbott C8000 chemistry analyzers. Prefilled, bar-coded cartridges help make processing drugs of abuse user-friendly and error-free. Bar-coded reagents help eliminate the need for assigning reagent positions and programming other reagent information. The bar codes track the lot number, expiration date, and calibration frequency. Prefilled cartridges help eliminate aliquoting reagents into empty containers and eliminate the need for labeling reagent containers. The immunoenzymatic assays are very stable; calibration stability is 7 days, and on-board stability is 30 days. The bar-coded feature allows use of the within-lot-calibration feature, reducing calibration frequency. The company offers a line of calibrators and controls, and its multianalyte calibrator allows calibration of multiple tests from a single cup of calibration material, streamlining the process. A variety of calibrator cutoff points, such as opiates 300 and 2000, and THC 50 and 100, are available to meet the needs of labs—and comply with NIDA requirements. Multipoint calibrators for producing quantitative results also are available, and three levels of controls for all analytes are offered.
OratectX Oral Fluid Drug Screen Device
The new OratectXP™ from Branan Medical Corp, Irvine, Calif, is a patented test device for drugs of abuse in saliva that provides results with a one-step procedure. Results can be interpreted within 3 minutes. The design helps eliminate gender observation requirements, sample contamination, and the transfer of specimen to a separate device. It is noninvasive and user-friendly, and provides built-in confirmation sampling for further testing. The device detects four drugs: marijuana, methamphetamine (such as ecstasy), cocaine, and opiates. No collection site is needed to perform the test, and it can be performed at an employer’s facility, allowing for immediate job placement.
Branan Medical Corp
Nanogen Inc, San Diego, offers a new product that accurately identifies a wide range of drugs of abuse in a cost-effective configuration. Featuring a comprehensive test menu, Tox STATus detects up to 10 drugs of abuse with a single test, helping hospitals and urgent care facilities to maximize reimbursement claims and contain costs. The device eliminates cumbersome steps during the testing process, which helps meet the demands of urgent care environments. Positive results can be read in 5 minutes, and lab-correlated results are ready in 15 minutes or less. It can be used as a tool that helps assess and treat patients with complications due to drug overdose. The product can be stored at room temperature for up to 18 months, requires low sample volume, and accommodates multiple drug combinations. It has been cleared by the FDA. Test results are stable for up to 4 hours, and the product provides 99% correlation to GC/MS at 95% confidence level. A control line ensures an accurate reading. An optional i-Lynx data-capture device is offered that is an HL7 POCT1-A compliant interface. Used by emergency departments, emergency medical technicians, the military, and correctional facilities, and in the workplace.
Capillary CDT Assay
The automated carbohydrate-deficient transferrin (CDT) assay from Sebia Electrophoresis, Norcross, Ga, is a specific biomarker for detection of chronic ethanol consumption. It is performed via capillary electrophoresis and is a completely automated, stand-alone method that has received FDA clearance. The assay is suitable for screening and confirmation analysis due to its ability to visualize the total transferrin isoform pattern and to detect genetic transferrin variants. It automatically calculates percent CDT for each sample. Chronic alcohol (ethanol) use increases the concentrations of the CDT isoforms. The consumption of approximately 60 grams (or four to five drinks) of ethanol per day for a period of 7 to 10 consecutive days is required to cause an increase in the serum CDT fraction. Because CDT reflects alcohol intake during the 1 to 2 weeks prior to blood collection, and CDT levels return to normal in about 14 days, the test is suited for monitoring relapse and abstinence in an alcohol treatment setting. There is a trend toward investigating the utility of alcohol biomarkers as disease risk indicators in surgical and trauma settings. One study concluded that, due to the medical complications caused by excessive drinking for high-risk surgical and trauma patients, a detailed admission work-up is recommended, including an alcoholism-related questionnaire and preoperative CDT, GGT, and MCV testing.