Therapeutic Drug-Monitoring Assays
For use with plasma and serum sample types
The Beckman Coulter UniCel® and Synchron® Clinical Systems’ Therapeutic Drug Monitoring (TDM) assays are specifically engineered, formulated, and packaged to provide the critical elements of effective TDM analysis. When used in conjunction with a UniCel or Synchron Clinical System, these assays provide efficient TDM results. The comprehensive panel of TDM assays is enhanced to provide analysis of anticonvulsants, antiarrhythmics, aminoglycoside antibiotics, and antiasthmatics. The assays offer 60-day within-lot calibration (42-day within-lot calibration for Digoxin). They are used with plasma and serum sample types to speed the process by eliminating clotting, and include a multianalyte drug calibrator for theophylline, phenytoin, phenobarbitol, carbamazepine, and valproic acid, which improves lab efficiency. The assays provide enhanced formulation and eliminate interferences from hemolysis, lipemia, and bilirubin. The panel includes acetaminophen, alcohol, carbamazepine, cyclosporine, digoxin, gentamicin, lithium, phenobarbital, phenytoin, salicylate, theophylline, tobramycin, valproic acid, and vancomycin.
Beckman Coulter
(800) 352-3433;

Urine Screen Control
For the monitoring of drugs-of-abuse screening methods
Quantimetrix Drugs of Abuse urine screen controls 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 MDE. It 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). This 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).
Quantimetrix Corp
(800) 624-8380;

Oral-Fluid Drug Test
Samples can be collected anytime, anywhere
The Intercept® oral-fluid drug test is a drugs-of-abuse test that preserves the dignity of the individual being screened. Intercept oral-fluid samples can be collected anytime, anywhere, without the need for special collection facilities. Because each collection can be directly observed, the risk of adulterated samples is virtually eliminated. With Intercept’s collection service, donors can provide a sample and seal it in the shipping vial in approximately 2 minutes. The specimen vial and chain-of-custody form are then shipped overnight to laboratory partners performing Intercept testing. The laboratory uses immunoassay processes and reports negative results the same day the samples are tested. Positive results are confirmed using GC/MS/MS and are reported within 72 hours. The Intercept detects the NIDA-5 drug panel, which represents the most common drugs requested by employers for workplace drug testing. Additional drug tests are available for barbiturates and benzodiazepines.
OraSure Technologies Inc
(800) 869-3538;

Drug Screen Test
Detects multiple drugs and drug metabolites in urine
The Poly stat Panel 9 test is an in vitro immunoassay for the rapid detection of multiple drugs and drug metabolites in human urine. The test kit is used to obtain a visual, qualitative result. It is intended for professional and laboratory use only. The test detects nine drugs in one test with urine samples. Results are seen within 3 to 8 minutes. To perform the test, the user dispenses three drops of urine into each of the three sample wells. Results are given in as few as 3 minutes, and verified positive results are available in 8 minutes. Negative results are indicated when a line appears, while positive results are indicated with the absence of a line.
Polymedco Inc
(914) 739-5400;

Ecstasy Assay
Used for qualitative and/or semiquantitative analysis
The Syva® EMIT® II Plus Ecstasy Assay can be used for the qualitative and/or semiquantitative analysis of methylendioxymethamphetamine and closely related drugs in human urine. The liquid ecstasy assay is ready to use and based on EMIT technology. It is available in both large (1000 mL–9X129UL) and small (28 mL–9X029UL) kit sizes, supports 300 and 500 ng/mL cutoff levels, and complies with the proposed Substance Abuse and Mental Health Services Administration guidelines.
Dade Behring Inc
(847) 267-5300;

New Assays
Tests for amphetamines and ecstasy
Olympus has announced the availability of two new EmitT® II Plus assays: amphetamines and ecstasy. The assays expand the drugs-of-abuse testing capabilities of the entire Olympus AU® chemistry-immuno analyzer system platform, including the AU400/400e, AU600, AU640/640e, AU2700, and AU5400 chemistry-immuno analyzers. The Emit II Plus Amphetamines and Ecstasy assays come in a liquid, ready-to-use format with 30-day onboard stability. They are OSR bar coded for convenient reagent management. Specific calibrator cutoffs are provided in accordance with proposed Substance Abuse and Mental Health Services Administration guidelines.
Olympus Diagnostics Systems Group
(800) 223-0125;

Clinical Chemistry Tests
For drugs of abuse and toxicology 
Abbott Laboratories’ menu for drugs-of-abuse screening and toxicology assays includes amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, ethanol, methadone, opiates, phencyclidine, and propoxyphene. With the exception of ethanol, the assays use an enzyme-multiplied immunoassay technique, which uses antibodies that react with the particular drug being detected. If the target drug is present in the sample, highly specific antibodies attach to it and induce an optical change that can be measured by the immunochemistry system. The tests are designed for use on Abbott’s ARCHITECT® c8000™, ARCHITECT ci8200™, and AEROSET® Immunochemistry Systems; and they are available worldwide.
Abbott Laboratories
(847) 937-3774;

Oral Fluids Test
For drugs of abuse
Oratect® II, a test device for the detection of drugs of abuse in oral fluids, provides results via a one-step procedure. Collection and testing of oral fluids are combined in a single step producing results within 8 minutes and eliminating body-fluid handling. The amount of sample volume required is 0.5 mL to accommodate donors with dry mouth.
The test is designed to accurately detect six drugs, including marijuana (THC), amphetamine, methamphetamine, cocaine, opiates, PCP, and benzodiazepines. Since parent THC is present in the mouth cavity, the device’s cutoff concentration for parent THC is reduced to 40 ng/mL to provide a longer detection window. Presumptive positive results are confirmed by sending the collection pad of the Oratect II device in an included vial to a Substance Abuse and Mental Health Services Administration laboratory for GC/MS analysis.
Branan Medical Corp
(949) 598-7166;

Drugs-of-Abuse Controls
For urine toxicology
The Liquichek™ urine toxicology control, levels S1S and S2S, have been designed for use with Dade®/Syva EMIT® reagents for amphetamines, cocaine metabolite (benzoylecgonine), and MDMA (ecstasy). The controls are liquid, ready-to-use products prepared from human urine, and are designed to provide an unbiased assessment of a laboratory’s drugs-of-abuse testing system. Unopened, the controls are stable for as many as 3 years when refrigerated. Once opened, the controls can be stored in a refrigerator for 30 days.
Bio-Rad Laboratories Inc
(800) 224-6723;