July 2017 Product Focus – IVD

June 22, 2017
Automated cell counter

The GloCyte automated cell counter for CSF is an FDA-approved analyzer that delivers consistent TNC and RBC counts and timely turnaround with just 30 µL of sample per test using a novel combination of fluorescence imaging technology and a one-of-a-kind sample cartridge. GloCyte is linear down to 0 cells/µL with a limit of detection of 1 cell/µL for both TNC and RBC. Advanced Instruments

ESR analyzer

The iSED is a fully-automated ESR analyzer that is capable of analyzing samples in 20 seconds, using just 100µl of blood directly from the primary EDTA collection tube. The 20-position iSED has a continuous, random access feed and is also compatible with BD Microtainer MAP Microtubes without any additional sample manipulation, making it ideal for pediatric testing and avoiding QNS issues. No batching, pipetting, sample splitting, or duplicate primary tubes are necessary. The analyzer interfaces with any LIS, measures 14.3 x 10.5 x 13.4 inches, and is manufactured in the United States. Alcor

Pre-analytical interference monitoring

Specimen interferences are a contributor to pre-analytical variation that affects clinical chemistry testing. Liquichek serum indices help reduce pre-analytical errors caused by hemolyzed, icteric, and lipemic (HIL) specimens. Liquichek serum indices can be part of the pre-analytical phase of an IQCP program to monitor instrument detection of HIL specimens, and help improve patient test results. Bio-Rad

PCT assay

Diazyme’s procalcitonin (PCT) assay is a 510(k) cleared assay used for the quantitative determination of PCT in serum, EDTA or lithium heparin plasma samples. The assay is based on a latex enhanced immunoturbidimetric method and can be run on most Clinical Chemistry analyzers. PCT proteins in the sample bind to the specific anti-PCT antibody which is coated on latex particles, and causes agglutination. The degree of turbidity caused by agglutination can be measured optically and is proportional to the amount of PCT in the sample. Diazyme’s PCT assay kit consists of two liquid stable reagents: R1 and R2. Calibrators and controls are packaged separately. Diazyme

ELISA assay kit

The KRONUS 3-Screen Islet Cell Autoantibody ELISA Assay Kit is for the simultaneous and non-differential detection of GAD and/or IA-2 and/or ZnT8 autoantibodies in human serum. The kit depends upon the ability of the autoantibodies to act divalently and form a bridge between the antigens coated on the ELISA plate wells and the 3-screen biotin. Once this bridge is formed, streptavidin peroxidase attached to the colorogenic substrate (TMB) is bound. The 3-screen biotin and absorbance of each well is directly proportional to the amount of autoantibody present. For research use only. Not for use in diagnostic procedures. Manufactured under assigned patents and licenses. KRONUS

Blood gas analyzers

Nova Biomedical delivers critical care and point-of-care blood gas analyzers with the Stat Profile Prime Critical Care System (CCS). Prime CCS features no-maintenance cartridge technology consisting of individual cartridges for biosensors, calibrators, and automated, on-board, external liquid QC. This design optimizes cartridge life, improves analyzer uptime, and eliminates the waste, downtime, and higher costs of older, combined calibrator/sensor cartridge systems—providing exceptional value in a critical care whole blood analyzer. Prime delivers a full 10-test profile in just 60 seconds: pH, PCO2, PO2, Na, K, iCa, Cl, Hct, Glucose, and Lactate. Nova

Quality control module

Visiun’s quality control module provides sigma level performance of IVD clinical equipment to assist laboratories with their vendor selection. Comprehensive sigma metrics cover over 250 analyses representing all of clinical pathology including Chemistry/Heme/Coag/UA. Visiun covers real-world conditions reflecting day-to-day operations to ensure performance and efficiency is measured accurately from all vendors and instrument models. Visiun

Hematology analyzer

The BC-5390 is a five-part differential hematology analyzer with built-in autoloader and a single closed tube sample mode. The hemoglobin analysis is performed using cyanide-free reagent. The analyzer processes up to 60 samples per hour and stores up to 100,000 results with histograms and Scattergram. The barcode reader and optional LIS connectivity enable seamless sample data transmission. Nearly all scheduled maintenance procedures are automated by touch buttons. The intuitive software enhances workflow efficiency and provides operators with a pleasant user experience. Mindray