C270 DiaSys

ß-Hydroxybutyrate ready-to-use reagent

DiaSys offers an improved, liquid-stable and ready-to-use reagent for common clinical chemistry analysers. For the determination of ß-hydroxybutyrate (ß-HBUT) serum and plasma samples can be used. ß-HBUT is an important marker to detect diabetic ketoacidosis (DKA), a potentially life-threatening complication in diabetes mellitus, which can lead to coma or even death. The new ß-Hydroxybutyrate 21 FS offers a wide measuring range which ensures few sample repeats and therefore is time- and cost-saving. Interferences to endogenous and exogenous substances were minimized and calibration and on-board stability were prolonged to 12 weeks. The new ß-Hydroxybutyrate 21 FS is robust and provides accurate and highly reproducible results.

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C285 DIAsource toxo 1

ToRCH ELISA assays

DIAsource ImmunoAssays has announced the CE-IVD certification of 6 parameters of the ToRCH panel: Toxoplasma IgG Elisa # KAPDTOXOG; Toxoplasma IgM Elisa # KAPDTOXOM; CMV IgG Elisa # KAPDCMVG; CMV IgM Elisa # KAPDCMVM; Rubella IgG Elisa # KAPDRUBG; Rubella IgM Elisa # KAPDRUBM. The new assays have a common protocol (only 10µl of sample required) which allows their easy adaptation to most of the common automated ELISA platforms e.g. Stratec Gemini. The “IgG Elisa” are quantitative assays and include one control. The “IgM Elisa” are based on the IgM µ-capture technique, are qualitative assays and include three controls. Moreover, their high diagnostics specificity and sensitivity allow respectively the accurate detection of acute infection and the reduction of false positive cases. Lastly, the colour coded kit reagents offer easy recognition in a manual setting.

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C282 Chromsystems

Assays for the reliable determination of metanephrines in plasma

Chromsystems launched MassChrom Metanephrines in Plasma new CE-IVD assays for the efficient quantification of metanephrine, normetanephrine and 3-methoxytyramine by LC-MS/MS. The kits are available in two configurations, either with sample clean up columns or 96 SPE well plates. The assays encompass all required components and enable a simple and fast sample preparation in just a few steps. The analytes are chromatographically separated, avoiding co-elution and minimizing the risk of interferences.  Stable isotope-labelled internal standards for every single analyte ensure a reproducible and reliable quantification. The 6PLUS1 Multilevel Calibrator Set and MassCheck controls are based on human plasma to minimize matrix-induced differences. MassChrom Metanephrines in Plasma complement the full range of CE-IVD assays from Chromsystems for the determination of biogenic amines. These include assays for HPLC and LC-MS/MS and in the plasma and urine matrices. Laboratories with higher sample throughput can also rely on the company’s automated systems.

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HORIBA Solution HELO pic for top product 2

New high-range hematology system

In order to meet the needs of the mid-high size laboratories segment, HORIBA Medical has developed a new high range solution in hematology : the HELO Solution (HELO : HORIBA Evolutive Laboratory Organisation). Based on the combination of innovative and proven technologies, it is perfectly suited to laboratories whose throughput extends from 300 to 20,000 tubes per day. The analysers Yumizen H2500 / H1500 and SPS (slide stainer) are the new analytical cores of this system. The overall results (patients and quality controls) produced by the instruments are analyzed, checked and validated by the Yumizen P8000, a new generation of specialized hematology validation station (Middleware). This solution allows laboratories organized in multi-sites to centralize data management, optimize automatic validation of results (customizable rules engine), while controlling productivity, thanks to real-time performance indicators (status connection, maintenance, TAT, manual validation, etc.). The management of reagents and waste has been optimized and is an integral part of the HELO Solution. In addition, the company’s system of connected analytical devices and high throughput tube conveyer, the Yumizen T6000 connection automation system, allows the link of all the analysers. Based on several patents, the Yumizen T6000 system optimizes the flow of tubes, in order to offer the best possible TAT. It offers 4 types of configuration: linear to replace identical configurations; angle to adapt the configuration of your laboratory; workcell to maximize personnel efficiency and island to minimize the floor area. Combined with the QAP programme (Quality Assurance Programme) the HELO Solution is in full compliance with ISO 15189.

Come and see us at EuroMedLab 2017
Booth #14 (Skalkotas Hall – Level -1)
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HORBIA Yumizen H2500 Yumizen SPS Yumizen P8000 pic for top product 3

New range of hematology analysers

With a genuine throughput of 120 tests per hour for CBC including differential and nucleated RBCs, the Yumizen H2500 and Yumizen H1500 are able to absorb the workflow of laboratories with high activity. Both analysers are equipped with a three-dimensional count capable of combining the measurements of cellular complexity, volume and distribution for each of the leukocyte subpopulations. In order to manage leucopenic, thrombocytopenic and anemic samples, an integrated ‘low value’ cycle allows automatic readjustment of the counting constants. In addition, a new platelet determination system operates via two methods, impedance and optical extinction in separate channels. Also included is the company’s newest middleware, the Yumizen P8000, which allows laboratories to centralize data management and optimize automatic validation of results (customizable rules engine), while controlling productivity and real-time performance (connection status, maintenance, TAT, manual validation …). The Yumizen SPS can be optionally added to the Yumizen H2500 and allows fully automatic slide-making at a rate of 120 slides per hour. The Yumizen H2500 / H1500 + Yumizen SPS module are available as standalone units or combined in the HELO Solution (HELO = HORIBA Evolutive Laboratory Organization) allowing several instruments to be connected to the Yumizen T6000 high-speed tube conveyor.

Come and see us at EuroMedLab 2017
Booth #14 (Skalkotas Hall – Level -1)
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C278 Haematex new

DOAC removal tablets

DOAC-Stop removes all types of Direct Oral Anti-Coagulants (DOACs; dabigatran, apixaban, rivaroxaban, and edoxaban, etc) from test plasmas with minimal effect on underlying blood clotting tests. The simple procedure involves adding one mini-tablet per 1ml test plasma (volume is not critical), mixing for 5 minutes and centrifuging down the adsorbent. The resulting plasma is then depleted of DOACs and yields similar APTT, dRVVT, PT(INR) and other results as if DOACs had not been present. Reversing agents coming into therapeutic use for individual DOACs are not widely available for lab tests. DOAC-Stop is now offered for simplifying the diagnostic problems associated with DOACs. It absorbs up to an estimated 2,000ng/ml of any DOAC in less than 5 minutes. Unlike therapeutic  additives for reversing DOACs it leaves no residual effect. It can be used for checking if DOACs are present in samples giving unexpectedly prolonged clotting test or abnormal chromogenic test results. There is negligible interference with vitamin K antagonist or heparinoid anticoagulants. Plasmas treated with DOAC-Stop can be used for valid factor assays and in testing for thrombotic risk. In particular it can prevent false LAC positive results due to DOACs or other agents in testing for lupus anticoagulants. The product is currently for research use only.
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C294 Beckman

Software expands capabilities of flow cytometer in routine labs

Beckman Coulter has significantly expanded the workflow capabilities of its AQUIOS CL Flow Cytometer with the addition of the AQUIOS Designer Software, developed specifically to handle user-defined tests in the routine lab. The AQUIOS Designer Software allows for the creation of customer-defined applications to be run on an instrument that combines sample preparation and flow cytometry analysis in one platform (AQUIOS Load & Go technology). Until recently, this feature combination was only available for pre-defined applications like CD4 analysis and basic immunophenotyping. With traditional flow cytometry, sample preparation and analysis required a two-step approach carried out on different instruments. Even with semi-automated processes this would slow down the lab’s overall productivity and cause bottlenecks. It also limited the role of flow cytometry technology in today’s lab, which requires 24/7, streamlined workflow and a consistent turnaround time (TAT). Many laboratories now create their own reagent cocktails for routine applications to accommodate the specific marker combinations required by their individual focus. The addition of AQUIOS Designer Software fundamentally changes the way flow cytometry technology performs within the routine lab.  It reduces the routine, repetitive task of having to manually mix reagent combinations.  Far greater workloads can be handled quickly and efficiently, without bottlenecks. The optional AQUIOS Designer Software provides an intuitive and user-friendly interface with powerful features to set up user-defined protocols, acquisition templates, panels, compensation settings, and the parameters needed for statistical and quality control compliance. All features can easily be accessed via pull-down menus or slider bars. On the small footprint, high precision AQUIOS CL Flow Cytometer, sample loading is as easy as on a hematology analyser, with integrated automated sample preparation. It delivers first results within 20 minutes for routine applications such as immunophenotyping, with subsequent sample results at a rate of approx. 25 samples per hour for up to a full 96-well plate for each test of Tetra Combo. The company provides the reagents for user-defined assays either through the Contract Manufacturing (GMP) or Custom Design Services of user-defined reagents. Either option provides barcoded and cap-pierceable vials that can be run on the AQUIOS CL instrument with automated tracking of all QC functionalities, including reagent type, container ID, and lot number.

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C290 Edan crop

3-part hematology analyser

Edan is expanding its product line into the In-vitro diagnostics area by cooperating with BIT-Messer, Germany, who has accumulated experience in the IVD field for decades. The new line, consisting of a 3-part hematology analyser, is the culmination of that effort. Compact yet powerful, full featured yet affordable, simple yet reliable, the H30 provides 20 parameters and 3 histograms. With only 9.6µl needed for blood aspiration as well as the possibility of using capillary whole blood samples, the H30 could be an ideal choice for pediatric hospitals and clinical laboratories. The instrument just needs 3 reagents for sample analysis. Features of the analyser include low reagent consumption, high stability and zero maintenance of the tubing system.

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C293 Dirui

Urine microscopy and chemistry analyser

FUS-2000 Urinalysis Hybrid is a unique system integrating urine automatic microscopy and chemical analysis into a single instrument with one sample aspiration. Thanks to a flat flow cytometry technique applied to automatic microscopy, unlike other urine microscopy analysers, the FUS-2000 separates the same types of particles and puts them all in one category to review, allowing much higher linearity. Various strips choices and as many as 14 dry chemistry parameters provide doctors and patients with more diagnostic data. FUS-2000 software is intuitive, well-designed and up-to-date. With flexible and quick response to customers’ request, the software has relatively frequent upgrades with new features. The instrument saves labs space as well as time with its constant throughput of 240t/h in dry chemistry mode and of 120/h in sediments or hybrid mode. In addition, the FUS-2000 features extremely quiet operation.

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C292 Nova cropped

Capillary blood analyser for point-of-care testing

Nova Biomedical recently announced CE-mark certification for Allegro, a capillary blood analyser for point-of-care testing in primary care settings. Allegro and its StatStrip A companion meter provide 14 clinically important tests to monitor glycemic control, assess cardiac risk with a full lipids panel, and assess kidney function. All results are ready during the patient visit, simplifying clinic workflow and producing cost savings for providers, while offering clinical benefits for patients. All Allegro tests use easy capillary fingerstick sampling and disposable test cartridges or strips. To monitor glycemic control, Allegro provides HbA1c, glucose, and estimated average glucose tests. To assess cardiac risk, Allegro provides total, HDL, non-HDL, and LDL cholesterol tests, cholesterol/HDL ratio, and triglycerides tests. To assess kidney function, Allegro provides urine creatinine, urine albumin, and urine a1bumin/creatinine ratio, and blood creatinine with eGFR tests. Allegro is the only analyser that can measure HbAlc, lipids, glucose, and creatinine from a capillary sample. Its innovative design comprises dual measurement bays, which offers the ability to measure two cartridges simultaneously, doubling throughput and improving efficiency. Allegro’s companion meter wirelessly transmits results to the analyser, where they combine with all cartridge test results for one patient report. All results can be transmitted to electronic medical records for providers to review with patients during the visit. Having immediate results during the patient visit reduces clinic follow-up calls, letters, and patient re-visits, and improves patient satisfaction, compliance with care plans, and outcomes. The analysers’ HbA1c accuracy is certified by the National Glycohemoglobin Standardization program (NGSP), and total cholesterol and HDL cholesterol are certified by the U.S. Centers for Disease Control Cholesterol Reference Method Laboratory Network.
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