Siemens Healthcare is announcing the availability of the new INNOVANCE Heparin Assay for the BCS XP System and the Sysmex CS-2000i, CS-2100i and the CS-5100 Systems. This truly liquid testing solution generates precise results with fewer steps, streamlining workflow with easy-to-use reagents and a single hybrid calibration curve for both unfractionated heparin (UFH) and low molecular weight heparin (LMWH). Non-liquid heparin assays typically require labour-intensive reconstitution and mixing of reagents before testing can occur, impacting laboratory workflow. Unlike other liquid heparin assays that may need to stand for up to 30 minutes before use, the INNOVANCE Heparin Assay can be used immediately. The assay’s single calibration curve for both UFH and LMWH adds confidence to results by eliminating the risk of evaluation on the wrong curve. This new assay is designed to significantly reduce hands-on time and improve security so that heparin testing can become a more routine laboratory operation. Heparin is an anticoagulant used to prevent and treat blood clots in at-risk patients. It exists in two forms, UFH and LMWH, both of which are widely used as prophylactic and therapeutic anticoagulants. The INNOVANCE Heparin Assay utilizes a universal calibrator set that is traceable to the World Health Organization (WHO) standards for UFH and LMWH. Dedicated controls for UFH and LMWH have two levels each, and the hybrid calibration curve includes five levels for greater precision and accuracy. It exhibits excellent correlation between Siemens and Sysmex systems and offers a comparable number of tests per kit across all systems.
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Zivak Technologies supplies ready to use LC-MS/MS and HPLC analysis kits with its own fully automated sample preparation and injection system which enables laboratories to make efficient use of their LC-MS/MS as well as HPLC instruments. Many scientific studies and papers show the inaccuracy of measuring total vitamin D with commercial immunoassays without separating and measuring vitamin D2 and vitamin D3 metabolites individually. HPLC and LC-MS/ MS methods are accepted as the Gold standard for separate analysis of 25-OH metabolites of vitamin D. Usage of these chromatographic methods is increasing significantly in clinical laboratories in recent years. Many of these laboratories cannot use their systems effectively due to the fact that these systems require qualified staff, complex sample preparation steps, high kit prices/ operation costs and do not allow walk-away operation. The VD-200 was especially designed for routine vitamin D2/D3 testing clinical labs. VD-200 enables to analyse vitamin D2/ D3 samples fully automatically – without any human intervention – from primer sample tube. The company offers higher sensitivity than entry level LC- MS/MS thanks to the newly designed Special D detector. This system is fully validated with the Zivak vitamin D2/D3 UHPLC analysis kit which includes all necessary reagents, calibrator and controls. It offers a complete solution to clinical laboratories performing routine vitamin D2/ D3 assays on HPLC-UV and LC-MS/MS systems. As they have a large number of vitamin D2/D3 samples, they cannot run all the other LC-MS/MS specific analyses on their LC-MS/MS systems effectively. The VD-200 has been designed especially for this kind of laboratory, providing a cost-effective and fully automated system that frees expensive LC-MS/MS systems for specific tests which have to be run on LC-MS/MS systems. The innovative design of the VD-200 enables barcode reading, reagent adding, vortex mixing, centrifuge and injection processes to be done by robotic arms. The system provides 240 accurate results in 12 hours fully automatically.
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The Iris iRICELL workcell integrates urine chemistry and microscopy into a fully automated walk-away urinalysis system that is easy to use and maintain. The integrated workcell combines the iQ200 Series automated microscopy system with the iChemVELOCITY automated urine chemistry system. The iQ200 Series delivers clear, clinically relevant urine particle images that are auto-classified for more objective and consistent results. This automated microscopy system is designed for all volume workloads, delivering a shorter turnaround time and standardizing results. The iQ200 Series are available either as a stand-alone system or connected to an iChemVELOCITY urine chemistry analyser to form an automated iRICELL workcell. The iQ200SPRINT is one of the fastest automated systems on the market, meeting high-volume productivity and workload requirements. It can handle 101 microscopic samples an hour. The IQ200ELITE manages medium- to high-volume workloads running 70 microscopic samples an hour; with the iQ200SELECT more suitable for lowvolume workloads running 40 microscopic samples an hour. iChemVELOCITY provides a fully automated, high-capacity urine chemistry analysis with excellent low-end sensitivity. The system delivers a high throughput of 210 samples an hour, with the continuous strip loading and a capacity of 300 strip loads. It has a pad on the strip designed to detect and measure the presence of ascorbic acid. This provides clinically significant information about potential interference with key chemistry assays. The system evaluates all standard urine chemistry parameters, including glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite and leukocyte esterase.

<sup>Utility of reflex urine culture based on results of urinalysis and automated microscopy


Specimens submitted for urine culture in hospital settings are frequently negative for bacteria. Various approaches have been developed to select urine samples in the laboratory to improve the efficiency of handling these samples. At a time of concern for cost containment, utilization of a reflex testing policy using specific screening criteria would be beneficial to eliminate unnecessary urine cultures. With this in mind, an evaluation of Beckman Coulter’s IRIS iQ200 system (urinalysis and automated urine microscopy) was carried out in the US at the Johns Hopkins Bayview Medical Center (JHBMC) clinical microbiology laboratories. The study prospectively collected and reviewed 1248 clinical urine specimens submitted for urinalysis and/or urine culture. It investigated the IRIS iQ200’s utility in aiding a predictive algorithm for the implementation of reflex urine cultures. Findings showed that these test parameters, separate or combined, may be a useful screening method to determine the need for a reflex urine culture.</sup>
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The FDA-approved EUROPattern system provides fully automated evaluation of indirect immunof luorescence tests for anti-nuclear antibodies (ANA), antineutrophil antibodies (ANCA) and now also Crithidia luciliae (CLIFT), EUROPLUS antigens and cellbased assays (e.g. anti-neuronal antibodies). The EUROPattern system consists of a fully automated microscope with slide magazine and advanced diagnostic software for rapid recording, interpretation and archiving of IFT images. Up to 500 analyses can be processed in 2.5 hours, corresponding to 18 seconds per field. Slides are correctly identified by means of matrix codes. The controlled LED in the microscope provides over 50,000 hours of constant light intensity, ensuring highly reproducible results. Positive and negative results for the substrates are clearly differentiated by the powerful software. Crithidiae evaluation is based on specific kinetoplast fluorescence rather than just dark-light classification, increasing reliability. Different ANA, anti-cytoplasmic and ANCA patterns are reliably identified, even if more than one antibody is present. Furthermore, the software provides titre designations with confidence values. Images from further substrates such as liver, kidney and stomach or the new anti-Zika assay can be automatically recorded and archived. Images and results are viewed at the PC screen, and can be checked retrospectively at the microscope if necessary. The software consolidates all results into one report per patient and also compares new findings with previous records. Different user levels provide a hierarchical review of results, thus increasing security. The software can be fully integrated into existing laboratory software (LIS) for a streamlined laboratory routine.
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BioFire Diagnostics’ FilmArray Meningitis/ Encephalitis (ME) Panel is now available in the countries which recognize CE marking. The ME Panel provides highly beneficial medical value, as it addresses the critical unmet need for quick and accurate identification of central nervous system (CNS) infectious agents. The comprehensive ME Panel tests cerebrospinal fluid (CSF) for the 14 most common pathogens (6 bacteria, 7 viruses and 1 yeast) responsible for community acquired meningitis or encephalitis in about an hour. Currently, testing CSF for multiple organisms can take days and is not always possible because it can be difficult to obtain enough fluid from each patient to run multiple tests.
The ME Panel received a de novo clearance by the U.S. Food and Drug Administration (FDA) in October 2015. The ME Panel brings a unique opportunity to test simultaneously and rapidly for most bacteria, viruses and fungi found in those pathologies that can be extremely severe and sometimes lethal. Such an approach will positively impact the management of those patients by helping clinicians and biologists speed the diagnosis of these potentially severe conditions and make much faster decisions on appropriate therapy to prevent complications. More than 1.2 million people every year are affected by meningitis worldwide, resulting in 120,000 deaths globally from bacterial meningitis. Bacterial meningitis can occur suddenly in healthy people and even with prompt diagnosis and treatment, approximately 10% of patients may die and up to 20% or more may sustain permanent damage and disability. The ME Panel is cleared for the FilmArray and FilmArray 2.0 systems and is commercially available around the globe.
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