Combines monoclonal antibody with HTRF technology
Cisbio International, Céze, France, a global developer of HTRF technology and services used in assay development and drug screening, launches HTRF KinEASE TK, a universal, sensitive assay for high-throughput screening of Tyrosine (Tyr) kinases, major targets in drug discovery, in particular in oncology research. With the development of this new tool, Cisbio now offers its customers a reliable kinase screening platform based on one technology to address a broad range of kinase targets. It combines a peptide substrate called S4 and a single, proprietary monoclonal antibody with Cisbio’s homogeneous, time-resolved fluorescence (HTRF) technology, a highly sensitive, robust technology for the detection of molecular interactions of proteins in vitro. The new kit limits assay development time and is easily miniaturizable and flexible, so the assay can be performed under a wide range of kinase assay conditions with low consumption of enzyme or with any ATP concentration.
Human Alpha-1 Antitrypsin Antigen
Blocks destructive effects of some enzymes
Lee Biosolutions, St Louis, now provides Alpha-1 Antitrypsin Antigen to clinical researchers worldwide. Alpha-1 antitrypsin is a protein produced in the liver that blocks the destructive effects of certain enzymes. An alpha-1 antitrypsin concentration test is used as a tool to help diagnose the cause of early-onset emphysema, especially when a person does not present obvious risk factors such as smoking and exposure to lung irritants such as dust and fumes. Alpha-1 antitrypsin tests are also implemented in diagnosing the cause of persistent jaundice and liver dysfunction indicators, primarily in young children. Lee Biosolutions also offers affinity-purified polyclonal antibodies of antihuman alpha-1 antitrypsin, including goat antihuman alpha1 antitrypsin and chicken antihuman alpha-1 antitrypsin.
PBG Test Kit
Detects acute porphyria attack
Thermo Fisher Scientific, Pittsburgh, offers a urine porphobilinogen (PBG) screening kit that is a semiquantitative procedure for excluding an acute porphyria attack or identifying patients who need more specialized investigation. During an acute porphyria attack PBG accumulates in the liver, raising levels in the plasma and urine. An increase in urinary PBG is strongly indicative of an acute porphyria attack. The kit, based on the Watson– Schwartz method, utilizes an anion exchange resin (prepacked in a syringe) that binds PBG that might be present in a random urine sample. A simple washing step removes interfering compounds such as urobilinogen. PBG is then eluted off the resin and added to a dimethyl aminobenzaldehyde solution. If PBG is present in the sample, a magenta color develops that can be compared to a color chart included with the kit.
Thermo Fisher Scientific
Dual Path Platform Immunoassay Device
An alternative to SPLF
Chembio Diagnostics Inc, Medford, NY, received a US patent for its immunochromatographic immunoassay—the Dual Path Platform (DPP) Immunoassay Lateral Flow Rapid Diagnostic Test System. The immunoassay is an alternative to current, well-established single-path lateral flow (SPLF) assays, and has potential applicability for rapid point-of-care testing over a diverse range. Potential DPP immunoassay applications are broader than just infectious disease/serology rapid testing. The product can be used in all areas of in vitro diagnostics, and licensees will have a lower cost compared to licensing multiple, overlapping SPLF IP. The DPP employs separate membrane strips for sample migration and test reagents and is able to control sample flow and the immunological reaction.
Chembio Diagnostics Inc
Steadylite Plus and Britelite Plus
Can be stored in refrigerator
PerkinElmer Inc, Waltham, Mass, has developed two luminescent gene-reporter assay kits, Steadylite Plus and Britelite Plus, which deliver speed and sensitivity in new odor-free formulations. The kits offer high-throughput screening laboratories the same performance and reliability of the company’s current luminescent reporter gene reagents. They can be stored at refrigerated temperatures instead of freezer temperatures so they can be used immediately without thawing. The odor-free reagents eliminate the need for working in hoods. With its long-lasting signal, Steadylite Plus is designed for batch-processing systems, while Britelite Plus is designed for continuous process systems. Both kits are suitable for high-density microplates such as 384- and 1536-well plates in high-throughput environments.
Update of the 340
The Versant 440 Molecular System from Siemens Medical Solutions Diagnostics, Tarrytown, NY, combines the efficiency of complete branch DNA (bDNA) automation with the proven reliability of bDNA technology. The system streamlines workflow through the integration of barcoded data entry, automated reagent processing, detection, and the download of a patient worklist and results through an LIS interface. The Versant 440 provides laboratories with the flexibility to start a run any time and allows for the placement of the system anywhere in the clinical laboratory. The solution uses bDNA, which simplifies viral load testing by eliminating nucleic acid extraction and removing the risk of cross-contamination. Pending FDA approval, the Versant 440 will deliver molecular assays for HIV, HCV, and HBV.
Siemens Medical Solutions Diagnostics
Liquichek Spinal Fluid Control
Monitors automated and manual procedures
Bio-Rad Laboratories Inc, Hercules, Calif, has unveiled Liquichek Spinal Fluid Control, a liquid bilevel product designed to monitor the performance of automated and manual procedures for the analysis of proteins and other critical analytes assayed in cerebrospinal fluid. Most clinical interest in CSF electrophoresis focuses on the gamma region. Oligoclonal bands are multiple, distinct bands in the gamma zone of the CSF pattern that are not present in serum. This test helps support, though not confirm, the diagnosis of multiple sclerosis. Assayed values are provided to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Bio-Rad Laboratories Inc
CBC-5D Plus Retics
Whole blood 5-part differential
CBC-5D Plus Retics from R&D Systems, Minneapolis, is a trilevel whole blood control containing reticulocytes designed specifically for Beckman Coulter LH700 series hematology analyzers. Assay disks are provided for assay value uploading. The vial labels are also bar coded to allow the control sample values to load into the correct control file. The control is packaged in pierceable screw-cap 5.0 mL tubes and carries a 14-day open-vial and 105-day closed-vial stability. A companion calibrator product, CBC-CAL PLUS, is available. An online quality control program, CBC-Monitor Online, which includes a peer group analysis, is available to all CBC-5D Plus Retic customers.
AspirinWorks Test Kit
Test for heart health
Corgenix Medical Corp, Denver, a worldwide developer and marketer of diagnostic test kits, has received 510(k) FDA clearance to market its AspirinWorks Test Kit—the company’s newest diagnostic product. Those at risk for heart attack are eligible for aspirin therapy and should be tested for the presence or absence of the therapy’s effect. The test kit is an enzyme-linked immunoassay to determine levels of 11 dehydro thromboxane B2 (11dhTxB2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals postingestion. Unlike other platelet aggregation tests, which require freshly drawn blood that must be evaluated within at least 4 hours, the AspirinWorks test requires a urine sample that can easily be obtained in any doctor’s office.
Corgenix Medical Corp
Liquid Stable Calcium Reagent
Shelf life of 3 years
Diagnostic Chemicals Limited (DCL), Oxford, Conn, announced that the shelf life of its liquid stable calcium reagent has extended to 36 months from date of manufacture. This improved shelf life minimizes concerns about inventory management and ordering frequency. DCL’s liquid-stable, single-part calcium reagent incorporates the Arsenazo III test methodology to accurately determine concentrations of the analyte in serum. The reagent also displays a minimal specimen requirement, making it ideal for pediatric, geriatric, and veterinary testing. It has a rapid test turnaround time of less than one 1 minute by automated methods; a wide linear range, extending up to 20.0 mg/dL; and superior performance characteristics in test recovery, accuracy, and precision.
Diagnostic Chemical Ltd
Lee Biosolutions, St Louis, announces the availability of Human Hemoglobin, the latest in a long line of new products. Hemoglobin makes up roughly 97% of the dry content in red blood cells, and about 35% of a red blood cell’s total content. A molecule of human hemoglobin consists of 2 pairs of peptide chains (alpha and beta globins) and four heme groups, each with one atom of iron. Hemoglobin level is among the most routinely ordered blood tests, typically as part of a complete blood count. The amount of oxygen in body tissues depends on how much hemoglobin is in the red cells. Low hemoglobin levels usually indicate anemia. High levels may be caused by polycythemia vera, a disease in which too many red blood cells are made.
K-RAS Mutation Detection Kit
Employs real-time PCR
DxS, Manchester, UK, adds the K-RAS Mutation Detection Kit to its expanding portfolio of cancer mutation detection products. Recent publications suggest that in lung cancer patients the K-RAS mutation status is a strong predictor of resistance to therapy with tyrosine kinase inhibitors such as IressaT (AstraZeneca) and TarcevaT (Roche /OSI Pharmaceuticals). The mutation detection kit can identify these patients and also provide valuable biomarker information to drug companies with novel therapies in development. The kit is highly selective, detecting seven key mutations in the K-RAS gene. The company’s K-RAS assays employ a real-time PCR format combining ScorpionsR and ARMSR (allele specific PCR) technologies. The assays can detect <1% of mutant in a background of wild type genomic DNA and have a limit of detection of 10 copies or below.
+44 (0) 161 606 7201
Works with small tissue sizes
McCormick Scientific, St Louis, has introduced a processing cassette called the MicrOflow II Mini Cassette. Smaller tissue sample sizes are the result of technological advances in identifying tumor sites. Precise location of tumors is identified using MRI, CAT scan, and PET scan technologies. With the aid of x-ray and ultrasound image guided biopsy techniques, biopsy specimens may be obtained from these identified tumor sites. These small tissue specimens have created the need for the new McCormick Mini Cassette and Mini System, which deliver benefits through every stage of the tissue processing procedure.
CBC-LINE Ultra Low Kit
Tests low end of linear range of hematology analyzers
R&D Systems, Minneapolis, offers the CBC-LINE Ultra Low Kit, a reliable method to establish a hematology analyzer’s performance and reportable range at the very low end of the linear range for white blood cell, platelet, and red blood cell determinations. Linearity combined with independently verified and documented calibration is used to establish the range of lowest patient values that can be accurately reported. Each multilevel kit contains gravimetrically accurate linear dilutions of cell concentrates. The dilutions are packaged in 3-mL pierceable tubes. An extensive instrument evaluation report of the results is included at no extra charge with each kit.
Liaison VZV IgG Assay
Detects previous varicella zoster infection
DiaSorin Inc, Stillwater, Minn, has FDA clearance for its Liaison VZV IgG Assay, a fully automated, chemiluminescent immunoassay that can determine whether a varicella zoster infection has previously occurred. The assay is designed to allow for quick and accurate identification of susceptible individuals who could benefit from vaccination. First results are available within 35 minutes, and labs can produce 90 results per hour.
DMA-80 Direct Mercury Analyzer
Generates results in minutes
The DMA-80 Direct Mercury Analyzer from Milestone, Shelton, CT, enables clinical laboratories to directly analyze blood, hair, nail, and urine samples for trace level mercury (from 0.005 to1000ng) in minutes, without sample preparation or the need for chemical processing. A built-in, 40-position autosampler, unattended operation, and no-waste disposal requirements are only a few of its advantages when compared to conventional methods.
Microwave paraffin heating sheets
Energy Beam Sciences, East Granby, Conn, has announced a reliable microwave paraffin heating method: PolarHeat. For microwave histoprocessing, paraffin required preheating to the protocol temperature before microwave exposure to save time and protect tissue. Microwave ovens heat polar material like water and alcohol; paraffin is nonpolar, and will therefore not heat directly via microwave energy. Without preheating, microwave energy not absorbed by paraffin would be absorbed by microwave components, accessories, and patient samples, often causing damage—the microwave merely maintains, rather than raises, the temperature. PolarHeat makes it possible to heat paraffin safely in the microwave, at rates comparable to water or alcohol, while providing protection to irreplaceable patient samples. A single, disposable sheet, properly placed and immersed in paraffin, converts microwave energy to heat, absorbs excess energy that might otherwise damage tissue, and provides significant time savings.
Energy Beam Sciences
Line Series Kits
For all major hematology analyzers
R&D Systems, Minneapolis, offers Line Series Kits, providing a simple, consistent way to establish a hematology instrument’s performance and reportable range with ease and confidence. Gravimetrically accurate linear dilutions of cell populations are provided in each instrument-specific kit. CBC-Line kits, CBC-Line Low Level kits, and CBC-Line Ultra Low Level kits contain prediluted WBC, RBC/Hgb, and Plt levels. PLT-Line kits contain prediluted platelet levels, RET-Line kits contain prediluted reticulocyte levels, and GLU-Line kits contain prediluted glucose levels. Each kit covers the following performance analysis: validation of analytical measurement range, verification of reportable range, analytical sensitivity, analysis of bias and imprecision error, and linearity check.
Susceptibility disks for agar diffusion test
The UriStar-AST from Hardy Diagnostics, Santa Maria, Calif, is a ring of five susceptibility disks recommended for the agar diffusion test procedure (Kirby-Bauer) for rapidly growing bacterial pathogens isolated from urine cultures. The test simplifies the process of urine susceptibility testing and contains the five most commonly used antibiotic disks for antimicrobial susceptibility testing on urine isolates. The 6-mm disks are linked by a ring structure, which enables easy handling of the disks without the need for antibiotic disk dispensers. The UriStar-AST allows users to set up Kirby-Bauers with perfect spacing every time. Antimicrobials impregnated on each disk include amoxicillin/clavulanic acid, cephalothin, ciprofloxacin, nitrofurantoin, and trimethoprim/sulfamethoxazole.