Dengue Virus Proteins
12-month shelf life
Aalto Bio Reagents, Dublin, Ireland, offers a line of Dengue virus proteins from serotypes 1–4 for diagnostic test manufacturers, vaccine developers, and researchers. The upsurge in Zika virus serology and molecular testing is making it increasingly important to screen for other arboviruses with similar clinical presentations to Zika virus, including chikungunya virus and Dengue virus. Proteins are purified by immobilized metal-chelate affinity chromatography. The products have a shelf life of 12 months stored at –20°C.
Aalto Bio Reagents
[email protected]; www.aaltobioreagents.com
For heparin-induced thrombocytopenia
Instrumentation Laboratory (IL), Bedford, Mass, recently received FDA premarket notification (510(k)) clearance of the HemosIL HIT-Ab(PF4-H) assay for use on ACL Top family hemostasis testing systems. The fully automated, on-demand assay for heparin-induced thrombocytopenia (HIT) detects antibodies associated with HIT, a severe immunologic adverse reaction to a heparin complex that paradoxically causes blood clots to form. Diagnosis of HIT is key to positive patient outcomes and may prompt the use of alternative anticoagulants. A positive or negative result from the liquid, ready-to-use immunoassay aids in determining a risk for HIT when used in conjunction with other laboratory and clinical findings. For prescription use.
(800) 955-9525; instrumentationlaboratory.com
Developed for mid-volume laboratories
Siemens Healthineers laboratory diagnostics business has launched the Sysmex CS-2500 system, a mid-volume, fully automated coagulation analyzer with preanalytical sample integrity (PSI) technology to identify and automatically manage problematic test samples prior to analysis. The launch of the new Sysmex CS-2500 system will enable mid-volume laboratories to leverage globallyproven PSI technology, while providing regional reference laboratories and integrated delivery networks with the ability to standardize testing results across multiple Sysmex CS and CA hemostasis systems. The system features simultaneous multiwavelength scanning and such PSI technologies as primary-tube sample-volume checks, clog detection, assay-based preanalytical sample-quality checks for hemolysis, and clot waveform analysis. With an onboard capacity of up to 3,000 tests and up to 40 reagents, the Sysmex CS-2500 system delivers extended walkaway time to streamline workflow.
(888) 826-9702; usa.healthcare.siemens.com
Parathryoid hormone control
Available in liquid, human-based serum format
The new Acusera parathyroid hormone (PTH) control from the quality control division of Randox Laboratories, Crumlin, UK, is a third-party control for assessing the performance of tests for the measurement of intact PTH. The notoriously unstable marker, present in a number of immunoassay controls, is now available in a liquid, human-based serum format. The product has an open-vial stability of 30 days at 2–8°C, and a 2-year shelf life. It is designed to deliver an unbiased, independent assessment of analytical performance with any instrument or method.
(866) 472-6369; www.randox.com
Syphilis TP Test
Uses two algorithms
The Architect syphilis TP test from Abbott, Abbott Park, Ill, can detect antibodies to Treponema pallidum (TP), the bacterium that leads to syphilis infection. Upon infection with TP, an immune response develops that is directed not only against antigens specific to TP but also antigens released during TP-mediated cellular damage. A positive treponemal test result is an indication for an acute, latent, or past infection with TP. Nontreponemal tests are especially valuable for monitoring disease activity and therapy response. Abbott’s test is a treponemal test that detects IgG and IgM antibodies to TP. Two different algorithms, which combine a treponemal with a nontreponemal test, are used as an aid in diagnosis of syphilis. The algorithm starting with the treponemal test is called a reverse screening algorithm and has been implemented in laboratories due to the availability of automated treponemal tests.
(800) 553-7042; www.abbott.com
Automated Cell Counter System
Requires 30 µL of sample per test
Advanced Instruments Inc, Norwood, Mass, has received FDA premarket notification (510(k)) clearance to market its GloCyte automated cell counter system and GloCyte low- and high-level controls. The patented GloCyte system is intended to provide quantitative determination of red blood cells and total nucleated cells in cerebrospinal fluid (CSF) collected from adult and pediatric patients. Requiring only 30 µL of sample per test, the system uses disposable test cartridges, ensuring no sample carryover and easy disposal. The system also includes built-in quality control using Levey-Jennings charts and an audit table.
(800) 225-4034; www.aicompanies.com
Clinical Chemistry Analyzer
Produces 800 photometric test results per hour
Mindray, Mahwah, NJ, and MedTest, Canton, Mich, recently announced that they have received FDA premarket notification (510(k)) clearance to market and sell the Mindray BA-800M clinical chemistry analyzer. Meeting the testing needs of mid- and high-volume laboratories, the BA-800M chemistry analyzer produces 800 photometric test results per hour with an overall throughput of 1,200 tests per hour with ion-selective electrode. A sample delivery module provides a sample capacity of 440 positions, while the system’s reagent consumption design minimizes reagent use per test and reduces reagent bottle dead volume. Advanced features include continuous reagent loading, reagent bubble detection, water quality monitor, one-key stat touch button, probe liquid level detection, and sample probe clot and collision recovery. MedTest is the analyzer’s exclusive US distributor.
(800) 445-9853; www.medtestdx.com
Infectious Disease Control
Assesses HIV 1, hepatitis B, and hepatitis C tests
Bio-Rad Laboratories Inc, Hercules, Calif, has announced its continued expansion into the molecular diagnostics testing market with the launch of the Amplichek I quality control, for which FDA recently issued premarket notification (510(k)) clearance. The control is the second in a series of infectious disease controls that Bio-Rad has introduced for the molecular diagnostic testing market this year. Amplichek I is an independent, multianalyte quality control for the assessment of HIV 1, hepatitis B, and hepatitis C nucleic acid tests that can help mitigate the limitations of manufacturer controls. Amplichek I can help reduce the risk associated with reporting inaccurate patient results by monitoring the performance of the complete analytical process and detecting lot-to-lot variation of assay reagents.
(800) 424-6723; www.bio-rad.com
Pipette Calibration System
Includes touch-sensitive software
Artel, Westbrook, Maine, has introduced its next-generation pipette calibration system (PCS) designed to optimize pipette performance and boost confidence in data integrity. In addition to easy pipette calibration, the system offers an enhanced intuitive user interface for simplified scheduling and reporting, and a unique operator assessment module that standardizes pipetting technique across all skill levels. It is also equipped with touch-sensitive software and a streamlined design, including an integrated bar code scanner. Furthermore, the PCS can function as a scheduling tool for employees’ proficiency assessment plans and as a pipetting technique training tool to help meet compliance requirements.
(888) 406-3463; www.artel-usa.com
Sports wide, fingerhook design
Thermo Fisher Scientific, Waltham, Mass, has released two pipetting systems designed for accurate liquid transfer in a range of applications spanning high-throughput pharmaceutical and biotechnology laboratories to small academic and industrial laboratories. The redesigned Finnpipette F1 pipettes and Thermo Scientific F1-ClipTip pipettes now have added features designed to improve user comfort and productivity: volume adjustment with a textured knob provides a firmer feel when setting volumes, and a wider fingerhook design and handle-grip strips provide improved stability and a more secure, comfortable grip. Additionally, the lightweight handle and lower plunger help reduce the risk of repetitive strain injury.
Thermo Fisher Scientific
(800) 556-2323; www.thermofisher.com
Lateral-Flow Coupling Kit
Promotes monolayer binding
Anteo Technologies, Eight Mile Plains, Australia, has launched a new lateral-flow coupling kit. Designed for magnetic and nonmagnetic latex and silica particles ranging in size from 200 nm to 500 nm, the kit contains Anteo’s patented activation reagent with buffers for conjugating antibodies to a range of particles used for lateral-flow applications. Hands-on time for surface activation and coupling is 60 minutes. Promoting monolayer binding, the kit enables binding to any antibody without pretreatment.
[email protected]; www.anteotech.com
Point-of-Care Immunoassay System
Generates results 12 minutes or less
Sekisui Diagnostics, Lexington, Mass, has expanded its point-of-care (POC) diagnostics product line through a recent partnership agreement with Qualigen Inc, Carlsbad, Calif. Sekisui is now the exclusive worldwide distributor of the FastPack IP system, Qualigen’s POC immunoassay system. Based on chemiluminescent technology, the system delivers rapid results for FT4, hCG, testosterone, total and free PSA, TSH, and vitamin D. The FastPack IP system is a patented, fully automated, compact, quantitative immunoassay-based system that generates immunoassay results in 12 minutes or less. The system was designed specifically for the physician office and is designated as moderately complex under the terms of the Clinical Laboratory Improvement Amendments of 1988.
(781) 652-7800; www.sekisuidiagnostics.com
Combines plastic and glass properties
The DualFusion vial from Wheaton, Millville, NJ, combines properties of plastic and glass into a single container. Using plasma-enhanced chemical vapor deposition technology, an organosilicate protective layer is fused with a silica-like (SiO2) barrier layer that is fused to a cyclic olefin polymer (COP) shell to form a robust covalently bonded material. The outer COP shell provides mechanical strength, protects against breakage, and can withstand a temperature range of –196oC to 121oC without cracking. The inner layer is designed to maintain sample integrity and protect sensitive reagents. Furthermore, each ready-to-use, ready-to-sterilize vial has a unique barcode for rapid and easy traceability.
(800) 225-1437; wheaton.com
Enables the characterization of 37 exosome surface markers
Miltenyi Biotec, Bergisch Gladbach, Germany, has extended its portfolio with the MacsPlex exosome kit for humans, enabling the characterization of 37 exosome surface markers in a single experiment. The company developed the kit for the automated characterization of exosomes using flow cytometry. The screening approach is based on fluorescent immune conjugates—MacsPlex exosome capture beads—which are included in the kit and bind different exosome-specific epitopes. The MacsPlex exosome detection reagent marks the bound exosomes with the pan-exosome markers CD9, CD63, and CD81. The result is a sandwich complex, consisting of the MacsPlex exosome capture bead, the exosome, and the detection reagent, which can subsequently be analyzed based on their respective fluorescent properties. Using flow cytometry, one can obtain semiquantitative data on 37 exosomal surface epitopes.
(530) 888-8871; miltenyibiotec.com
Urine Collection Tube
Supports hygienic urine collection
Sarstedt, Nümbrecht, Germany, has released a 3.2 ml volume Urine Monovette tube in a 13 mm x 75 mm configuration for small-volume or dimensional requirements. The Sarstedt Urine Monovette system enables hygienic urine collection and testing without needles, adapters, cups, or transfers. All tubes are manufactured from impact-resistant medical grade plastics and feature secure screw caps for safe handling. After collection using a syringe technique, the plunger handle is removed to create a primary tube for transport, direct analysis, and centrifugation. Urine Monovettes are also available in 8.5 ml and 10 ml volumes, with and without preservative, in a white option to protect light-sensitive analytes, with a Luer-lock adapter for Foley catheters, and bulk or individually wrapped sterile.
(800) 257-5101; www.sarstedt.com