C426 Haematex DOAC STOP product image

Direct oral anti-coagulant adsorbent

DOAC Stop eliminates all direct oral anti-coagulants (DOACs) from test plasmas, making it possible to obtain valid results for all conventional coagulation assays and tests for thrombophilia.  This adsorbent has amazing affinity for DOACs but no effect on clotting proteins, antibodies or heparins. Because it extracts only DOACs, a clotting test result which remains abnormal can be assumed to have other causes.  DOAC Stop minitabs (one/ml) disperse readily in plasma and take less than 5 minutes to bind more than 95% of DOACs in most cases. The adsorbent is quickly removable after it has done its work by centrifugation.  The minitabs work equally well on direct thrombin inhibitors (eg dabigatran) and those against FXa (rivaroxaban, apixaban, edoxaban) and have no effect on heparins or warfarin plasmas.  In most cases DOAC levels can be estimated quickly from the ratio of clotting test results before to after the extraction via an appropriate calibration curve. The best results are obtainable using high phospholipid dRVVT or APTT reagents.

HAEMATEX
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C427 Mobidiag Novodiag

Automated molecular diagnostics system for targeted and syndromic on-demand testing

Novodiag is an innovative molecular diagnostics solution for the detection of multiple or targeted pathogens in clinical samples. Combining qPCR and microarray technologies in a single-use cartridge containing all the necessary reagents, the Novodiag system allows an extremely simplified analysis process with minimal preparation time and results in approximately 1 hour. The latest addition to the tests already available includes detection of Clostridium difficile (Novodiag C.difficile), identification of bacteria responsible for gastrointestinal infections (Novodiag Bacterial GE+) and screening of more than 200 variants of most common CPE and colistin-resistance markers (Novodiag CarbaR+). Two new tests will be launched this year: one for the detection of parasites in stool with the identification of more than twenty targets (protozoa including microsporidia and helminths) and another for the diagnosis of meningitis. The complete system comprises the Novodiag instrument, touchscreen computer, barcode scanner, Novodiag software and Novodiag cartridge.

MOBIDIAG
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C444 BIOMERIEUX vidas 3 couverture 10091 01

Anti-HEV IgG and anti-HEV IgM tests for diagnosing hepatitis E

BioMérieux has expanded its hepatitis panel, which already included diagnostic tests for hepatitis A, B and C, with the launch of two VIDAS hepatitis E tests. Hepatitis E is a widely underdiagnosed liver disease that is prevalent all over the world. It is caused by infection with hepatitis E virus which is mainly transmitted by the fecal-oral route, particularly through contaminated water and some undercooked meats. It is a serious pathology, since it can lead to fulminant or chronic hepatitis which can prove fatal if not properly treated. The number of infections with the hepatitis E virus is estimated at 20 million per year, including more than 3.3 million acute cases. bioMérieux is now able to offer laboratories and clinicians the first automated serological tests for anti-HEV in a single-test format to diagnose the pathology reliably and quickly (40 minutes).
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C437 SEBIA Anticorps

Next generation free light chain assay

Sebia is expanding its offer with two innovative CE-IVD marked assays for the determination of serum free light chains: sebia FLC Kappa and sebia FLC Lambda. Serum free light chain assays (sFLC) form part of the diagnosis, prognosis and monitoring of multiple myeloma and other monoclonal gammopathies.
Sebia FLC Kappa and sebia FLC Lambda are clinically validated for patient diagnosis and follow-up. These tests are not affected by the analytical limits observed on the current nephelometric and turbidimetric methods used, i.e. antigen excess leading to underestimation of the result, small measuring range resulting in many re-dilutions and overestimation of the sFLC value leading to a discrepancy with electrophoresis results.
Overcoming these limitations, sebia FLC provides the added benefits of a significant cost reduction and a major improvement of the analytical performance.
With this next generation of serum free light chain assays, Sebia complements the existing range of electrophoresis tests for myeloma.
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C442 ROCHE Cobas Infinity 3

Software advances lab integration

Roche recently announced the release of cobas infinity 3.0, its proven global lab software solution  to help diagnostic laboratories maintain high operational performance, quality, integration and security within their labs across multiple locations.
One new feature further improves the intelligent routing of samples in high volume testing labs by dynamically adapting to changing lab conditions, such as priority testing, to reduce time to results. New improved quality control features ensure that the highest quality results are reported consistently, while new monitoring features secure high performance and stability of analysers and reagents 24/7 without additional costs. Finally, the addition of more work areas for different clinical laboratory disciplines (such as molecular, hematology, coagulation, etc.) enable lab staff to focus on what matters most to them. Additional features include an easy-to-use interface that allows lab technicians to customize and personalize their lab environment set-up across multiple sites.
The cobas infinity lab software management solution helps laboratories integrate a wide range of key processes along the patient journey from ordering diagnostic tests to actual test results. It does this while automating the entire sample flow and bringing meaningful insights for informed decision making about patient care and treatment options.
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C439 STAGO ST Genesia

Thrombin generation now available in laboratories

The new ST Genesia analyser is designed to automate and standardize results for thrombin generation. For laboratories, this is a significant step forward for assisting with assessment of thrombotic and hemorrhagic risks in patients.
ST Genesia is an automated analyser, based on the same principles as the CAT system, which measures thrombin generation. Designed to support clinical applications in the lab, the key difference between systems is that CAT’s main purpose is for research and development.
ST Genesia aims at standardizing and automating the thrombin generation test in order to make it widely accessible and available for use in in-vitro diagnostics (IVD). ST Genesia is designed to add to the information usually provided by routine tests (TP, TCA, etc.) or specialized tests (Anti-Xa, ECA) and offer an improved assessment of thrombotic and hemorrhagic risks.
A range of reagents specifically developed for ST Genesia is available including STG-ThromboScreen for thrombin generation assessment in patients who are likely to suffer from thrombophilia; STG-BleedScreen for thrombin generation assessment in patients with bleeding risk, such as hemophiliacs; STG-DrugScreen for assessment of the effect of anticoagulants on treated patients, which could be useful for people at risk of drug accumulation (impaired renal function, people over 75, etc.).

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C436 BECKMAN DxA 5000 NEW IMAGE

Total laboratory automation solution sets new standard for turnaround time

Beckman Coulter announced early May that the latest addition to its automation portfolio, the DxA 5000 total laboratory automation solution, has achieved European CE Mark and China Food and Drug Administration approval. In today’s healthcare environment, laboratories are highly focused on enhancing patient care by driving faster turnaround time, delivering quality results and improving laboratory operations. The DxA 5000 helps laboratories meet these challenges through a collection of patented innovations that deliver rapid and consistent turnaround time, provide a new level of comprehensive pre-analytical sample quality detection, and reduce the number of manual processing steps to significantly improve laboratory efficiency.
Reporting results faster to physicians can positively impact patient outcomes. In the laboratory, specimen centrifugation is typically the most time-consuming pre-analytical activity. The DxA 5000 sets a new standard by utilizing a universal centrifugation protocol that significantly reduces the pre-analytical processing time by up to 73% for connected analysers across multiple disciplines.
Additionally, the DxA 5000 supports laboratories in delivering highly consistent turnaround time to their physicians. Leveraging first-of-its-kind dynamic system software, the DxA 5000 utilizes Intelligent Routing to bring automated patient-centric workflow to the laboratory. By understanding the tests requested, sample volume available and real-time analyser capacity and status, the DxA 5000 continuously calculates the most expeditious route for every patient sample – both STAT and routine.
Research shows errors that occur in the pre-analytical phase of testing may contribute up to 75% of erroneous test results, with 26% possibly having adverse effects on patient care.  Moreover, a vast majority of the factors causing erroneous results occur outside the laboratory, including inadequate volume, mislabeled samples and incorrect tube type. The DxA 5000 is designed with a sharp focus on sample quality assessment, screening each sample at multiple points to help laboratories substantially reduce the risk of errors. In three seconds, the system detects patient tube parameters such as volume, sample identification, tube type, cap colour, orders pending and tube weight. The system is also designed to check for sample volume at three separate points: pre-centrifugation, post-centrifugation and prior to sample storage to continually ensure sufficient volume is available for the tests ordered. Together, these quality assessments reduce the potential for release of erroneous results and can help accelerate time to result by quickly alerting the laboratory when a new patient sample is needed.
In addition to improving sample quality, laboratories also require workflow solutions that help them manage high volumes of outpatient, outreach and network samples, while processing urgent requests for both patient wards and emergency departments. The DxA 5000 simultaneously manages high volumes of multiple discipline requests, with a large variety of patient sample tubes and sizes, without impact to overall system throughput or STAT turnaround time. By automating sample processing steps, the DxA 5000 supports laboratories in delivering a higher number of results per hour with the same staffing level.
Based on research and work performed with the company’s laboratory partners, sample processing steps are shown to make up approximately 70% of a laboratory’s labour hours. The DxA 5000 significantly reduces the number of manual steps in sample processing to as few as one. From sample accessioning and quality assessment to add-on test management and sample disposal, the DxA 5000 enables laboratory professionals to deliver high-quality results and improve efficiency, empowering them to focus their efforts and skills on managing patient sample exceptions.
The first in a suite of DxA systems currently in development, the DxA 5000 enhances Beckman Coulter’s comprehensive portfolio of scalable solutions and is a key component of its vision to bring workflow automation to laboratories of all sizes.
Beckman Coulter has received purchase orders for more than 20 DxA 5000 systems across multiple countries where regulatory clearance has been achieved.

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C438 Thermo Fisher Sensititre ARIS HiQ System jpg 650

Instrument for automated antimicrobial susceptibility testing

A new benchtop automated reading and incubation system is now available in Europe for antimicrobial susceptibility testing (AST). The new instrument provides microbiology laboratories with the accurate MIC results that clinicians need to confidently select an effective antibiotic for critically-ill patients while safeguarding future patient care through more successful antimicrobial stewardship. The Thermo Scientific Sensititre ARIS HiQ AST System relies on broth microdilution, the industry’s gold standard, to provide an MIC result that supports the optimization of treatment decisions and ultimately, patient outcomes.
The new system adds value to laboratories that routinely retest invalid AST results or that require additional confirmatory testing prior to releasing results to clinicians. The immediate accuracy of phenotypically-driven MIC values delivers reliable results while minimizing re-tests and can support a reduction in hidden costs associated with reporting delays. Through close collaboration with leading pharmaceutical companies, the Sensititre System also offers one of the widest, most up-to-date selections of antimicrobials, enabling earlier access to the latest therapies for multidrug-resistant infections. In addition, laboratories can create their own custom AST plates from a selection of over 300 antimicrobials in broad dilution ranges to consolidate and reduce offline testing. The new Sensititre ARIS HiQ AST System provides microbiology laboratories with a unique combination of class-leading broth microdilution technology, for the most accurate AST, and access to cutting-edge antimicrobials. The availability of an AST device can determine whether or not a particular therapy can be used for a critically-ill patient. As the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) continue to report on the increasing threat of antibiotic resistance, the ability to use these newer antimicrobials is more important than ever.
The Sensititre ARIS HiQ AST System has an expanded capacity of up to 100 Sensititre plates in a limited footprint that makes it possible to process more tests at one time while conserving valuable bench space. It also features an intuitive touchscreen user interface for convenient operation; 24/7 access to critical test information; and batch load and unload capability for improved testing workflow.
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C435 EUROIMMUN ELISA microplate manuell

ELISA for urinary sCD163 measurement

Urinary soluble CD163 (sCD163) is a novel non-invasive marker of renal inflammation, and its determination supports early detection and monitoring of active glomerulonephritis (GN). Studies by experts in the field led by Prof. Mark Little (Trinity College, Dublin, Ireland) showed that significantly increased sCD163 levels in urine are present in up to 87% of patients with active ANCA-associated vasculitis (AAV) with renal involvement. In contrast, only slight increases are detected in AAV patients in remission, patients with acute kidney failure or sepsis, and patients with AAV without kidney involvement (O’Reilly et al. Am Soc Nephrol 27: 2906–2916, 2016). Furthermore, urinary sCD163 is elevated in patients with non-vasculitic forms of GN, especially in patients with lupus nephritis class IV (Endo et al. J Nephrol Dial Transplant. 31(12): 2023-2033, 2016).  sCD163 is a macrophage activation marker. The sCD163 level in urine correlates directly with the kidney disease activity, reflecting the accumulation of CD163+ macrophages in the glomeruli in response to pro-inflammatory stimuli. The direct correlation with renal inflammation means that urinary sCD163 is superior in performance to standard urinary markers, which have limited value in identifying a renal relapse. Monitoring of urinary sCD163 values can help to predict renal flares before irreversible kidney damage occurs and might enable invasive kidney biopsies to be avoided.  sCD163 can be measured quantitatively in urine samples using a new ELISA from EUROIMMUN. The detection is based on monoclonal anti-sCD163 antibodies. Values are determined by means of a simple cut-off-based interpretation using 6 calibrators. The EUROIMMUN sCD163 ELISA will soon be available as IVD CE-marked assay.

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CLI TRIMERO EPN on July 4 2019

C1q, C1 Inhibitor, C5 and Factor B assays for nephelometry and turbidimetry

TRIMERO offers C1q, C5, C1 (Esterase) Inhibitor and Factor B (C3 Proactivator) CE- marked assays for nephelometry and turbidimetry.
Assays are available for IMMAGE® immunochemical systems of Beckman Coulter and for BN™ Series nephelometers of Siemens Healthineers.
Turbidimetric assays and applications are also available for the most popular clinical chemistry analysers.
In order to ensure lot to lot traceability, values ​​have been referred to the International Ref. Preparation for human serum complement Factors (NIBSC code: W1032) of the WHO (World Health Organization). 
Other available assays for nephelometry and turbidimetry include:
KLoneus® Free Light Chains (FLC), Serum Amyloid A (SAA), IgD Immunoglobulins, Retinol Binding Protein (RBP) for serum and urine, Soluble Transferrin Receptor (sTfR), Hemopexin, Cystatin-C for serum and urine, A1-Microglobulin, B2-Microglobulin for serum and urine, Kappa and Lambda Light Chains for serum and urine.
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