The BioPlex 2200 System is the industry’s first fully automated, random access multiplex testing platform. It combines innovative, reliable automation with the diagnostic power of proprietary multiplex chemistry and state-of-the-art eFlex software to bring a new level of flexibility and operational benefits to the laboratory. It improves workflow with random access sampling and priority processing. Performing multiplex analysis on the BioPlex 2200 is easy: simply load a tray of primary tubes and walk away. The system can automatically process up to 100 samples per hour – for a maximum of 2200 reportable results (assay-dependent) – with eight hours of walk-away capability. First results are available in approximately 40–60 minutes (assay-dependent), with subsequent patient samples completed approximately every 30 seconds. BioPlex 2200 immunoassays use magnetic 8 µm beads, infused with varying ratios of fluorescent dyes to create unique bead sets. Beads within each set are coated with a ligand (i.e. antigen, antibody, analyte, etc.) specific to a particular assay. Bead sets are then mixed in a single reagent pack, allowing for simultaneous detection of multiple analytes from a single sample. The dual-laser, multiplex flow detection method processes a minimum of 150 individual bead results for each assay. Intuitive, touch-screen eFlex software allows precise system control and powerful information management. eFlex interfaces with the laboratory information system (LIS) and direct connectivity solutions for troubleshooting, reportable billing and Internet-based QC programmes (i.e. Unity). Add-on tests can be ordered from previously processed samples without a patient redraw. Users can also create custom test groups, fine-tune quality control rules to accommodate facility needs and analyse results using interpretive software algorithms (available with certain panels). The expanded menu covers autoimmune, infectious diseases and vitamin D testing.

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A new addition to the Stat Profile line of blood gas critical care analysers, Stat Profile Prime Plus, has gained CE mark certification and is now available in all CE-regulated countries. Prime Plus features maintenance-free sensor technology to provide 22 essential critical care tests including blood gases, electrolytes, metabolites, hematology, and co-oximetry. Prime Plus also features new and patented, non-lysing whole blood co-oximetry technology, along with automated quality control (QC), powerful data management, bidirectional connectivity, and extensive cybersecurity protection. Prime Plus incorporates Nova’s innovative, maintenance-free sensor technology with individual MicroSensor cards, calibrator cartridges, and quality control cartridges. This design eliminates sensor and co-oximeter maintenance, improves analyser uptime, and reduces testing costs. The MicroSensor Card provides 22 whole blood assays including co-oximetry and new critical care assays for urea, creatinine, and ionized magnesium. Prime Plus provides a complete co-oximetry panel without chemically or mechanically lysing the blood, which eliminates corrosive lysing reagents and mechanical complexity and improves instrument reliability and reduces costs. Prime Plus delivers a comprehensive critical care panel in about one minute from 135 microliters of whole blood. Tests include pH, PCO2, PO2, SO2%, Na, K, Cl, iCa, iMg, TCO2, glucose, lactate, urea, creatinine, Hct, Hb, O2Hb, COHb, MetHb, HHb, HbF, and tBil. A special safety sample port allows for easy docking and hands-free sampling, and the Clot Bloc sample flow path protects sensors from blood clot blockages and related downtime. Prime Plus provides total quality monitoring with automated QC that verifies analyser accuracy and precision on assayed liquid controls, and supplemental quality monitoring that electronically monitors and verifies correct performance of all analytical components for each analysis and calibration. It also features a powerful data management system and bidirectional connectivity, remote analyser review and control of connected Prime Plus analysers, and the most comprehensive cybersecurity features to protect patient health information and prevent viruses.

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Cystatin C (CysC) is an endogenously expressed, non-glycosylated protein known as a sensitive biomarker for early detection of kidney failure. Beside its obvious advantages over creatinine in estimating the glomerular filtration rate, it has not yet found its way in clinical routine. One major reason for this was the lack of a suitable standardization process, which changed in 2010 with the availability of the certified reference material, ERM-DA471/IFCC. DiaSys achieved excellent results in a recent multicentre study with its Cystatin C FS assay with major advantages over competitors. The results showed that among all tested immunoturbidimetric CysC assays, only the DiaSys test met the performance criteria at the four relevant concentrations. Cystatin C FS is a particle-enhanced immunoturbidimetric test featuring outstanding analytical sensitivity, high prozone security and excellent onboard/calibration stability.
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BioSystems is introducing BA200, a benchtop analyser with a real throughput of 200 t/h with any combination of methods and parameters (or up to 286 t/h including 4-channel ISE option), washing station, barcode identification and ISE capabilities. Offering the highest loading capacity of its segment, with 88 positions barcoded, that could be adjusted with specific adaptors to be used either as reagent, sample (primary or pediatric tubes), standard or control, it provides maximum configuration flexibility to adapt to the workload of any small or medium size laboratory, from routine to special chemistries. A BioSystems’ patented LED light source allows a precise focus in the reading spot area with no energy loss, increased signal and a sustained performance over its lifetime, over 50,000 hours of continuous operation without change of intensity, reducing their maintenance to almost zero. Also, the newly developed Dynamic Baseline procedure allows multiple readings to be made as the rotor is spinning to obtain highly accurate blank readings used to offer higher reliability for low absorbance values, thus improving significantly the CV% of the test at low values. Finally, the BA200 system introduces also a dedicated range of reagents in package size adequate to small and medium laboratories (but also fully compatible with BA400 system), ensuring the highest performance and on-board stability.

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BioVendor has now launched hsa-miR-21-5p miREIA, a quantitative assay combining molecular diagnostics and immunoassay technology. MiRNA isolated from a patient sample is hybridized to a complementary biotinylated DNA oligonucleotide probe. The miRNA/DNA hybrids are then processed in an ELISA format in a microtitre plate coated with a monoclonal antibody specific to perfectly matched miRNA/DNA dimers. The miREIA kits have been designed to quantify circulating miRNA from whole blood, enabling investigators to explore these promising biomarkers in various conditions including cancer, cardiovascular diseases, pulmonary diseases, regulation of immunological processes, reliably and in an easy-to-use format.
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