May 2017 Product Spotlight: Immunoassay Analyzers

Digital Influenza Immunoassay
Meets updated FDA performance requirements
BD, Franklin Lakes, NJ, has announced that its BD Veritor system Flu A+B, a digital immunoassay for the rapid detection of influenza, meets new FDA performance requirements. FDA recently reclassified antigen-based rapid influenza detection tests (RIDTs) intended to detect influenza virus directly from clinical specimens from Class I devices into Class II devices subject to special controls. With the new FDA requirements, rapid flu tests, which are used by healthcare providers and laboratory personnel, must now attain a higher level of performance.
BD
(201) 847-6800; www.bd.com

Benchtop Immunoassay System
Performs up to 36 tests per hour
The Vidas 3 from bioMérieux, Marcy l’Etoile, France, is a benchtop immunoassay system that can perform up to 36 tests per hour, on demand, individually, or in series. The FDA-cleared and CE-marked instrument incorporates enhanced preanalytical automation features, including automated scanning of reagents and barcoded primary sample tubes for improved traceability, automated calibration and onboard dilution, and new software capabilities. Three separate racks each containing three configurable segments can hold a total of 27 samples, diluents, and calibrators. Users have access to more than 100 tests in a single-test format for the diagnosis of allergies, cancers, cardiovascular diseases, infectious diseases, infertility, pregnancy, and thyroiditis.
bioMérieux
(800) 682-2666; www.biomerieux.com

High-Throughput Immunoassay System 
Processes up to 240 tests per hour
Designed for hospitals and reference laboratories that demand high throughput, the Advia Centaur XPT immunoassay system from Siemens Healthineers, Tarrytown, NY, can process up to 240 tests per hour and offers laboratories a portfolio of more than 70 disease-state tests. The system consolidates infectious disease testing otherwise conducted on multiple instruments for improved efficiency and better turnaround time. It enables uninterrupted processing through on-the-fly loading and unloading of samples, reagents, and supplies. The system also eliminates the lengthy automated monthly cleaning procedure for increased uptime.
Siemens Healthineers
(888) 826-9702; usa.healthcare.siemens.com

Rapid Immunoassay Testing System
Suited for POLs or any POC testing needs
Designed to provide rapid, accurate quantitative immunoassay results with the push of a button, the FastPack IP system from Sekisui Diagnostics, Lexington, Mass, fits into any size physician office laboratory (POL) or any facility with point-of-care (POC) testing needs. Requiring 200 µl of sample, the system can deliver results for free thyroxine, human chorionic gonadotropin, prostate specific antigen, testosterone, thyroid stimulating hormone, and vitamin D in 12 minutes or less. The system utilizes a simple three-step process: add sample, load pack in system, push ‘run’ button.
Sekisui Diagnostics
(781) 652-7800; www.sekisuidiagnostics.com

Open ELISA Analyzer
Automates manual tests
The ASI Infinity fully automated enzyme-linked immunosorbent assay analyzer by Arlington Scientific Inc is designed to run virtually any enzyme immunoassay application from most manufacturers while still being in compliance with regulatory requirements. The walkaway system can automate nearly any manual assay, saving labor, time, and bench space. The ASI Infinity can perform multiple assays with distinct incubation periods or unique wash solutions simultaneously. The stainless steel probe and dedicated wash cup eliminate the need for expensive disposable pipette tips.
Arlington Scientific
(800) 654-0146; www.arlingtonscientific.com

Rapid Response Chemiluminescent Analyzer
Delivers 450 results in a single shift
Inova Diagnostics, San Diego, offers Bio-Flash, a fully automated, random-access chemiluminescent analyzer for the autoimmune laboratory. Designed to enhance workflow efficiencies, the system achieves a throughput of 450 results in a single shift, and provides results in as little as 30 minutes. Stable onboard reagents allow for samples to be run as they arrive, and a reagent carousel stores up to 20 reagent packs with onboard refrigeration. Primary samples are placed directly onto the rack and scanned by an internal barcode reader. A master calibration curve is uploaded through the reagent pack barcode.
Inova Diagnostics
(800) 545-9495; www.inovadx.com

Automated ELISA
Featuring SmartKit technology
The Agility from Dynex Technologies, Chantilly, Va, is a fully automated, open system for enzyme-linked immunosorbent assay (ELISA) testing. With full walkaway processing and the ability to load up to 12 microplates onboard at once and multiple assays per plate, the Agility maximizes throughput in a benchtop footprint. Agility SmartKit technology allows for the direct loading of reagent bottles and lot-specific reagent tracking using unique 2D barcode software. Features include independent transport and pipetting arms, bidirectional LIS integration, and real-time monitoring software to measure consumable levels, timelines, and worklist performance.
Dynex Technologies
(800) 288-2354; www.dynex.com

Immunoassay Platform
Offers ultrasensitive measurement capabilities
Quanterix, Lexington, Mass, offers a fully automated immunoassay platform with multiplexing and custom assay capabilities. The company’s single-molecule array (Simoa) technology provides ultrasensitive, single-molecule measurement capabilities to access previously undetectable proteins. Quanterix also delivers complete assay kits, including one for neurofilament light (NF-L), a protein biomarker that has been shown to be associated with traumatic brain injury, multiple sclerosis, and other neurodegenerative diseases. The Simoa NF-L assay is a digital immunoassay for the quantitative determination of NF-L in cerebrospinal fluid, plasma, and serum. The antibodies also crossreact with bovine, macaque, and murine NF-L epitopes, and the assay can be used for research with these species.
Quanterix
(617) 301-9400; www.quanterix.com