American Association for Clinical Chemistry
Better health through laboratory medicine
2008 New Product Review

 


BioPlex™ 2200 Vasculitis kit

Bio-Rad announces the first and only fully-automated, random-access multiplex solution for autoimmune systemic vasculitis testing. The BioPlex 2200 Vasculitis kit is a multiplex flow immunoassay for the semi-quantitative detection of IgG autoantibodies to myeloperoxidase (MPO), proteinase 3 (PR3), and glomerular basement membrane (GBM) in human serum. In conjunction with clinical findings, the test system is used as an aid in the diagnosis of anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitides, microscopic polyangiitis (MPA), necrotizing glomerulonephritis, Churg-Strauss syndrome, Wegener’s granulomatosis, and the autoimmune renal disorder, Goodpasture’s syndrome. The BioPlex 2200 Vasculitis Kit is intended for use with the Bio-Rad BioPlex 2200 System.

 


 BioPlex™ 2200 ToRC IgG Kit*

The BioPlex 2200 ToRC IgG kit is the first and only fully automated, random-access, multiplex kit for the quantitative detection of IgG antibodies to Toxoplasma gondii and Rubella and the qualitative or semi-quantitative detection of IgG antibodies to cytomegalovirus (CMV). This kit allows your laboratory to perform one, two, or all three of these assays simultaneously on as little as 5 µL of serum or plasma. The BioPlex ToRC IgG Kit is the latest panel of multiplexed assays in the expanding menu of infectious serology tests on the BioPlex™ 2200 system. *In development.

 


MRSASelect™

The new MRSASelect chromogenic medium is used for the qualitative detection of MRSA in 24 hours. This test can be performed on nasal specimens from patients and healthcare workers to screen for MRSA colonization. Chromogenic media are used to grow bacteria in the laboratory and identify them based on a color reaction. With this medium MRSA can be differentiated from other microorganisms.


Hepatitis EIA Microplate Assays

Bio-Rad announces the launch of its new microplate EIA Hepatitis line (Hepatitis A and B): MONOLISATM Anti-HBs EIA, MONOLISATM Anti-HBc EIA, MONOLISATM Anti-HBc IgM EIA, MONOLISATM Anti-HAV EIA, and MONOLISATM Anti-HAV IgM EIA. These are qualitative assays with common reagents, standardized procedure, and colored reagents for monitoring procedural steps. MONOLISA Anti-HBs EIA is also quantitative when used with the calibrator kit. All assays are for manual and automated use. With these five new EIA assays, Bio-Rad is now offering a comprehensive hepatitis line expanding the current infectious disease menu of HBsAg, HIV-1, and HIV-2 assays.
 


in2it™*

Introducing Bio-Rad’s in2it A1C POC analyzer. This fully-automated system is designed for simplicity, convenience, and speed in near-patient testing, providing results while the patient waits. The in2it assay requires only 10 µL of capillary or venous blood and uses boronate affinity chromatography for results that are free from interference from the most common hemoglobin variants and traceable to the worldwide DCCT reference. The in2it analyzer is FDA cleared for prescription home use and is CLIA waived. The in2it supports multi-language screen displays and offers computer connectivity for complete data management.


Platella™ Lyme IgM and Platelia™Lyme  IgG

Bio-Rad announces a new Platelia Lyme IgM test kit and a new Platelia Lyme IgG test kit. These tests are qualitative and intended for use in the presumptive detection of human IgM and IgG antibodies respectively to Borrelia burgdorferi in human serum or plasma. They are EIA tests that can be used to test serum or plasma from patients with a history and symptoms of infection with B. burgdorferi. *Pending FDA clearance.

 


CandiSelect™4

CandiSelect™4 is a new chromogenic medium used for the selective isolation of several forms of Candida. This medium is designed for the direct identification of Candida albicans, the most significant member of the Candida genus, as well as the presumptive identification of Candida tropicalis, Candida glabrata, and Candida krusei. The CandiSelect™4 medium is currently the only chromogenic medium in the U.S. to presumptively identify Candida glabrata.


  
Liquichek™ Diabetes Control

The Liquichek Diabetes Control is a liquid, human, whole blood-based, third-party contol for monitoring the precision of hemoglobin A1c tests on commonly used methods and instruments. This control provides an unbiased assessment of the assay performance helping to improve the quality of test results. It is available in three levels and has a 3-year (-10ºC to -70ºC) frozen shelf life. Also available for Liquichek Diabetes Control are the Unity™ Interlaboratory Program with peer group comparison, and Unity Real Time™ software, a complete QC data management software system designed to improve the effectiveness of quality control processes.


  
Liquichek™ Microalbumin Control

The Liquichek Microalbumin Control is a liquid, human, urine-based, third-party control for monitoring the precision of microalbumin test procedures. Designed using human albumin, the control tests microalbumin across a wide range of popular instruments. Assayed values for microalbumin and creatinine are provided in two desirable levels. The control has a 30-day, open-vial stability at 2–8ºC and a 2-year shelf life at 2–8ºC. You may submit QC data for both analytes to the Unity™ Interlaboratory Program to obtain a monthly peer group report.

 


 

 


  
Lyphochek® Whole Blood Immunosuppressant Control

The Lyphochek Whole Blood Immunosuppressant Control is a lyophilized, third party, human, whole blood-based control that can be treated in the same manner as patient samples. It offers five individual levels and includes analytes cyclosporine, tacrolimus, and sirolimus from low to very high concentrations. Designed for use as an assayed QC material, this control monitors the precision of immunosuppressant drug test procedures in the clinical laboratory. It can be used with immunoassay or chromatographic techniques. Routine use provides a means to monitor the precision of test procedures and helps to ensure quality of reported test results.

 


  
Unity Real Time™ online

The Unity Real Time online program is a Web-based expert QC data management solution that facilitates regulatory compliance under CLIA and ISO 15189. It provides advanced statistical process control with audit trails, facilitates bench technologist and supervisory QC data review, offers comprehensive charts and reports, and enables participation in the Unity™ program, the most comprehensive interlaboratory program available to clinical labs. The Unity Real Time online program can also be used with the Westgard Advisor™ online program to automatically recommend and implement optimum QC rules. With the WebConnect™ feature, QC data can be uploaded directly into the Unity Real Time online program, eliminating the manual entry of data.

 


  
WebConnect™ 2.0

The key to improved lab QC is being connected to Bio-Rad’s Unity™ software, Web services, and the Unity Interlaboratory Program. Bio-Rad offers a complete suite of QC connectivity solutions designed to meet the needs of any lab environment. The WebConnect 2.0 system is a new addition to Bio-Rad’s suite of connectivity solutions, offering Web-based connectivity with no software to install. The WebConnect 2.0 Software allows labs to easily upload QC data from an instrument, middleware solution, and/or LIS directly into Unity software for complete QC data management. The WebConnect 2.0 system provides online QC connectivity for either the Unity Real Time™ online or UnityWeb™ 2.0 programs.

 


 

 


Westgard Advisor™ online

The patented Westgard Advisor online module is a Web-based, add-on module to Bio-Rad’s Unity Real Time™ online QC datamanagement solution that automatically recommends and implements optimum QC rules. By setting up proper QC design, the module decreases false rejections and helps attain designated quality goals with the highest error detection and lowest false rejection rate possible. This reduces false error flags and saves labs time and money associated with the reduction of unnecessary troubleshooting and repeats. The Westgard Advisor online module is very easy to use with a four-step wizard that guides users through the rule selection process.

 


  
UnityWeb™ 2.0

UnityWeb 2.0 is an entry-level, Web-based QC data management solution that facilitates regulatory compliance under CLIA and ISO 15189. The UnityWeb 2.0 system reduces IT dependence because no software installation is required. The program provides statistical process control with audit trails, charts and reports for data analysis, and enables participation in the Unity™ Interlaboratory Program for peer comparisons. The UnityWeb 2.0 system can also be used with the optional Westgard Advisor™ online module to automatically recommend and implement optimum QC rules. With the WebConnect™ program, QC data can be uploaded directly into the UnityWeb™ 2.0 system, eliminating manual entry of QC data.


 

 


Liquichek Tumor Marker Control

The Liquichek Tumor Marker Control is a liquid, human serum-based, third-party control used for monitoring the precision of tumor marker testing. This trilevel, multi-analyte control features 17 tumor markers: CA 15-3, CA 19-9, CA 27.29, CA 72-4*, CA 125, AFP, β-2-microglobulin, CEA, cyfra 21-1*, ferritin, hCG/β-hCG, IGF-1, PAP, prolactin, total PSA, free PSA, and thyroglobulin. The control has a 2-year shelf life when stored frozen, and 30-day, open-vial stability at 2–8ºC for most analytes. Assayed values are provided for manual and automated test methods, and participation in the Unity™ Interlaboratory Program is available.
*International use only. 


Gen5™CL Data Analysis Software

The latest in BioTek’s microplate data analysis software product line, Gen5 CL software is designed to provide powerful data analysis and output options in an intuitive user interface for the routine clinical lab. With Gen5CL, the user can select assays from a custom-programmed database or create open assays for optimal workload flexibility. The laboratory can ensure operational integrity by defining multiple permission levels to users on the system, and an optional QC Trending module can be installed for control tracking in Levey-Jennings charts. Gen5CL provides features designed for compliance to 21CFR Part 11 and the European Directive 98/79/EC (IVDD). 

 


Biotest Blood Group Serology Reagents

Biotest Traditional Blood Bank Reagents include ABO and Rh antisera, anti-human globulin reagents, potentiators, and QC products. The Reagent Red Blood Cell products include three configurations for antibody screening, antibody identification panels, coombs control cells, and reverse ABO products. Rare antisera includes anti-C, anti-E, anti-c, anti-e, anti-Lea, anti-K, anti-k, anti-Fya, anti-Jka, anti-Jkb, anti-M, anti-N, anti-S, anti-s, and anti-P1. All antisera are monoclonal and many of the clones have not been previously available in the U. S. *Pending FDA clearance.

 


Aware Messenger™

Aware Messenger is a research device for collecting, stabilizing, and transporting oral-fluid specimens used for detecting specific antibodies or analytes. Aware Messenger specimens may be adapted to conventional laboratory-based immunoassays (e.g., ELISA), enabling high-throughput batch testing, automation, quantitative results, and lower costs. The device provides a stabilized, high-quality, and immunoassay-friendly oral fluid specimen that is easily collected and requires no further processing (e.g., centrifugation). Aware Messenger specimens are rich in various analytes representative of those found in blood. Applications include detection of infectious disease antibodies and antigens, cancer markers, nucleic acids, illicit drugs, and hormones.
 


Chemistry Analyzer BioLis 24i

The new Carolina Chemistries BioLis 24i analyzer is a 400-test/hour, bench-top chemistry analyzer. With a menu of more than 100 chemistries, it serves well as a backup analyzer for hospitals that can’t afford to be down. Requiring only 31 inches of bench space, this instrument is also ideal as a primary analyzer for small hospitals and physician office laboratories where space is a consideration.

 


SpeciMinder™ Autonomous Specimen Transport System

The SpeciMinder autonomous mobile robot transports specimens within clinical labs and related areas. Onboard sensors guide the SpeciMinder through its environment, eliminating the need for control markings or external beacons. With a simple elevator-like user interface, operating the SpeciMinder is intuitive and uncomplicated. The robot is designed for 24/7 continuous operation and automatically recharges itself when batteries are low. Specialized electronics manage automatic doors and elevators as part of the SpeciMinder’s normal routine. The upper carrier section can be customized for a wide variety of payloads.

 


CellaVision® Body Fluid Application

Now body fluids can be analyzed on the CellaVision DM96 automated digital cell morphology system. Using a Cytospin slide preparation, the DM96 automatically performs a preliminary WBC differential and allows the user to scan the entire cell button. Regions of interest can be tagged, comments added, and images stored and shared anywhere on your network. An online reference library, access to a patient’s historical images, and real-time collaboration ensure the accuracy and standardization of the analysis. Body fluid slides can be run at the same time when performing WBC and RBC differential on stained peripheral blood smears.