Drug Assays

Detects amphetamines, cocaine, and PCP

Ortho-Clinical Diagnostics, Raritan, NJ, a Johnson & Johnson company, Ortho-Clinical Diagnostics, a Johnson & Johnson company, has announced the FDA 510(k) clearance and worldwide availability of eight new MicroTip assays for use in the diagnosis and treatment of drug use or overdose. The assays are used to detect the presence in urine of amphetamines (AMPH), cocaine metabolites (COCM), phencyclidine (PCP), barbiturates (BARB), benzodiazepines (BENZ), cannabinoids (THC), methadone (METD), and opiates (OP). These Vitros Chemistry Products reagents are used on the Ortho-Clinical Diagnostics Vitros 5,1 FS Chemistry System. The new assays allow the consolidation of drugs of abuse testing (DAT) with routine chemistry testing on a single platform using the VITROS 5,1 FS System.

Ortho-Clinical Diagnostics
(800) 421-3311; www.orthoclinical.com.

Trilevel Control

15-day open-vial stability

Liquichek D-dimer Control from Bio-Rad Laboratories, Hercules, Calif, is a trilevel control for monitoring the performance of D-dimer tests on most automated coagulation and chemistry/immunochemistry analyzers. This control includes values for the bioMérieux Vidas; Roche Cobas Integra and Hitachi systems; Diagnostica Stago STA Series, Instrumentation Laboratory ACL Series; Mitsubishi PATHFAST; Dade Behring Stratus CS and BCT/BCS; and Sysmex CA series. The control is liquid, ready to use; and each level is individually packaged in 6- x 1.0-mL configurations. This product has a 15-day open-vial stability at 2°C to 8°C and a 3-year shelf life when stored at -20°C to -70°C. Controls from a third-party manufacturer provide an unbiased assessment of any testing system. They can help detect assay problems early and improve the quality of results. The Unity Interlaboratory Program is available through the life of the lot. Users may also subscribe to one of the company’s Unity QC data-management solutions designed to improve the effectiveness of your statistical process control.

Bio-Rad Laboratories
(800) 224-6723; www.bio-rad.com/diagnostics.

Immunoassay Control

Designed to complement Lyphochek and Liquichek

The Liquichek specialty immunoassay control from Bio-Rad Laboratories, Hercules, Calif, is the first liquid, third-party, multianalyte control that includes Intact PTH with 30-day open-vial stability. It is designed to complement the popular Lyphochek and Liquichek immunoassay plus controls. This product is specially formulated to include Intact PTH, Anti-TPO, Anti-Tg, C-Peptide, IGF-I, 25-Hydroxy vitamin D, and osteocalcin. This human-based product has a 2-year shelf life when stored frozen. It provides 30-day open-vial stability at 2°C to 8°C for Intact PTH and most analytes. Assayed values are provided for manual and automated test methods. Three critical levels are available. The Unity Interlaboratory Program is available through the life of the lot. Customers can also subscribe to one of its Unity QC Data Management Solutions designed to improve the effectiveness of statistical process control. A sample of Liquichek specialty immunoassay control is available upon request.

Bio-Rad Laboratories
(800) 224-6723; www.bio-rad.com/diagnostics.

Drug Screen

Awarded CLIA-waived status

Branan Medical Corp, Irvine, Calif, has announced that the QuickTox Rapid Drug Screen has been awarded CLIA-Waived status. CLIA-Waived status indicates that the test is easy enough to be used by both laboratory and nonlaboratory personnel. Now, the device can be used at all sites, including treatment centers and hospital laboratories, without having to follow CLIA guidelines. CLIA-Waived status demonstrates that the unit is not only simple to use but is also reliable and accurate enough to pass the rigorous requirements of CLIA-Waived classification. The unit is a one-step test for the rapid detection of five to 11 drugs of abuse and requires no instrumentation or accessory supplies. To use QuickTox, just uncap the device and dip it into a specimen cup for approximately 10 seconds. Recap the device, and lay it on a flat surface. The test results are available within 5 minutes or less and include an internal procedural control. Results can be read for up to 1 hour and can be easily copied or photographed to maintain a permanent record. The test has an 18-month shelf life when stored at room temperature (59°F to 86°F).

Branan Medical Corp
(949) 598-7166; www.brananmedical.com.

Shiga Toxin Test


The BioStar OIA Shigatox assay is an innovative immunoassay for the qualitative, rapid detection of the presence of Shiga toxins in human diarrheal fecal specimens, broth culture, or colonies collected from a culture plate. The in vitro diagnostic test from the Bedford, England-based company is an aid in the diagnosis of infection by Shiga toxin-producing Escherichia coli (STEC) and other Shiga toxin-producing enterohaemorrhagic organisms. Due to the morbidity and mortality associated with outbreaks and sporadic cases of Shiga Toxin-producing bacterial diseases. these pathogens are considered major public health problems of worldwide importance. The assay is the only rapid diagnostic test directly capable of analyzing stool samples without overnight growth or pretreatment. The assay provides a simple test methodology, allowing all laboratory personnel to perform the test. Results are available in 15 minutes compared to other products that can take hours or days. This rapid and reliable detection method can be used to aid improved patient care by reducing days spent in hospital and the costs associated with unnecessary procedures and antibiotics.

(800) 637-3717; www.biostar.com.

Mitochondria Isolation

Able to maintain intact membranes

Focus Mitochondria kit from G-Biosciences, St Louis, enables the fast and simple isolation of enriched mitochondrial fractions from animal cells and tissue. By reducing sample complexity, more in-depth mitochondrial studies can be performed. The majority of the isolated mitochondria obtained from this kit contain intact inner and outer membranes. The line of products will not affect downstream applications.

(800) 628-7730; www.gbiosciences.com.

Controls for Fast HIV Testing

No reconstitution is required

RNA Medical, a division of Bionostics Inc, Devens, Mass, has introduced the Xsera Rapid HIV-1/2 Antibody Controls. This product has been evaluated for use with FDA-cleared rapid HIV test kits. The controls are solutions of heat-inactivated human plasma and require no reconstitution before use. They feature a 2-year shelf life when stored refrigerated (2°C to 8°C) and may be stored for up to 60 days at room temperature (up to 30°C) after opening. The controls are provided in screw-cap vials, each containing 1 mL of solution. Kits contain one vial each of HIV-1 antibody-positive, HIV-2 antibody-positive, and HIV antibody-negative controls. HIV-1-positive control source materials are reactive for antibodies to HIV-1. HIV-2-positive control source materials are reactive for antibodies to HIV-2. HIV-negative control source materials are nonreactive for antibodies to HIV-1 and HIV-2.

RNA Medical
(800) 533-6162; www.RNAMedical.com.

TB Test Kit

Complies with NCCLS guidelines

The TB Prep Kit from Hardy Diagnostics, Santa Maria, Calif, contains the reagents necessary for the decontamination and digestion of sputum specimens for the recovery of Mycobacterium spp. Each kit is packaged with five vials of premeasured NALC (N-acetyl-L-cysteine), five bottles of premixed and filtered TB Digestion Solution, and detailed instructions for their use. The kit’s components are designed to comply with NCCLS guidelines for the processing of sputum samples for mycobacteria. Phosphate Buffer rinse solution can be purchased separately, giving technicians the choice and flexibility of four different bottle styles to meet their individual needs. These ready-to-use reagents eliminate time-consuming hours of weighing, pH adjustment, and filtering; and require no additional measuring or mixing.

Hardy Diagnostics
(800) 266-2222; www.hardydiagnostics.com.

For more information on lab products go to the buyers guide and search for the companies listed in this section.