Abbott’s CELL-DYN Ruby Receives FDA Clearance
Abbott’s CELL-DYN^® Ruby™, an automated, midvolume analyzer designed to bring flexibility and convenience to hematology laboratories, received 510(k) clearance from the US Food and Drug Administration (FDA) in July. With its advanced laser optics, the CELL-DYN Ruby offers enhanced cellular analysis and greater efficiency for laboratories performing complete blood counts, a test routinely ordered by physicians to assess a patient’s overall health and to screen for a variety of disorders such as anemia and infection.

A key facet of CELL-DYN Ruby is its use of laser light to differentiate cellular components. Known as multi-angle polarized scatter separation (MAPSS™), this all-optical technology provides detailed results in easy-to-view diagrams, visually depicting changes in white blood cells, red blood cells, and platelets. CELL-DYN Ruby also underwent a multi-center medical evaluation showing clinically equivalent results with CELL-DYN Sapphire™, a higher-volume, automated analyzer introduced about a year ago.

To streamline inventory and simplify laboratory operations, CELL-DYN Ruby requires only four reagents. Additionally, the instrument uses advanced, intuitive software with online tutorials to help facilitate training.

“First-pass efficiency has been a hallmark of the CELL-DYN family of analyzers and an important part of improving patient care by providing hematology results quickly” says Harold Flynn, Abbott’s divisional vice president and general manager, hematology. “CELL-DYN Ruby further enhances our instrument portfolio by bringing a premium, midvolume analyzer to support the needs of small- to medium-sized hospital laboratories and clinics.”

Abbott’s full line of automated hematology instruments includes the CELL-DYN Sapphire, CELL-DYN Ruby, CELL-DYN 3700, CELL-DYN 3200, CELL-DYN 1800, and CELL-DYN SMS™ (slide maker stainer).

Abbott
(847) 937-3932; www.abbott.com

Nanogen Introduces New Analyte-Specific Reagents
The NGEN™ RVA analyte-specific reagents (ASRs) can be used to develop and validate assays to detect the sequences of and differentiate among influenza A and B; respiratory synctial virus; and parainfluenza 1, 2, and 3. Assays validated using NGEN RVA ASRs can be carried out with various sample types, including nasal swabs; and once validated by the laboratory, they can be used as a clinical diagnostic test. The product was developed in cooperation with Prodesse Inc, a leading supplier of molecular-based reagents for infectious-disease targets, and it is available in the United States as an ASR for which analytical and performance characteristics are not established. The product has been CE-marked in the European Union as an in vitro diagnostic and is available outside the United States.

Like all NGEN-brand reagents, these RVA reagents are specifically designed for PCR amplification, SNP genotyping, insertion/deletion detection or pathogen-sequence detection by use of a two-color fluorescence-detection system. The product line also includes reagents for mutations associated with cystic fibrosis, thrombosis, and hereditary hemochromatosis.

Nanogen Inc
(877) 626-6436; www.nanogen.com

Inverness Launches MMV for the AtheNA Multi-Lyte
Inverness Medical Professional Diagnostics has announced the availability of the AtheNA Multi-Lyte^® MMV test system, which is based on Luminex’s proprietary xMAP^® technology. The AtheNA Multi-Lyte MMV test system is intended for the qualitative detection of IgG-class antibody to measles, mumps, and varicella-zoster in human serum simultaneously in a single well. The use of the system allows for more reliable and accurate results, since each result is the median of at least 50 discrete events. The system has the capability to report results separately and/or simultaneously, and allows for additional results to be obtained well after the sample is discarded by analyzing data stored within the system.

The AtheNA Multi-Lyte test system uses Intra-Well Calibration Technology™, a proprietary technology designed to provide improved accuracy. Intra-Well Calibration Technology includes a multipoint standard curve within the bead suspension. Each patient sample is calibrated internally without any user intervention. The standard curve is designed to self-adjust based upon the unique characteristics of the patient or control serum. Sample verification is accomplished visually using SAVe™ Diluent, a color-changing sample diluent. The test procedure is the same as those AtheNA Multi-Lyte test systems currently in use.

The MMV test system is the latest in the ever-expanding menu of the AtheNA Multi-Lyte test system. The AtheNA Multi-Lyte software allows for flexible patient monitoring, automatic Levey-Jennings plots, population statistics, and more.

Inverness Medical Professional Diagnostics
(800) 257-9525; www.invernessmedicalpd.com