C416 Euroimmun

Automated evaluation of IFA for infection diagnosis

The EUROPattern system has been extended to include computer-aided evaluation of indirect immunofluorescence assays (IFA) for infectious disease diagnosis. Parameters encompass Chlamydia spp., Bartonella spp., Mycoplasma spp., HHV-6, CHIKV, coxsackievirus, EBV, DENV, hantaviruses, sandfly fever viruses, YFV and ZIKV. The assays utilize infected cells, antigen-expressing cells or bacterial smears to detect the corresponding antibodies in patient samples. IFA BIOCHIP Mosaics provide combinations of different substrates for efficient multiplex analyses. The EUROPattern microscope provides automated acquisition of the immunofluorescence images for convenient evaluation at the PC screen. It allows fast automated focusing and image recording for up to 500 fields in less than two hours. Slides are identified by means of matrix codes, eliminating the risk of mix-ups. Results can be checked retrospectively at the microscope if necessary. For selected parameters, e.g. EBV, sophisticated classification software provides positive/negative classification of the fluorescence signals, including titre designations with confidence values for positive samples. Negative results can be verified in batch for increased efficiency. The controlled LED in the microscope provides over 50,000 hours of constant light intensity, ensuring highly reproducible results. Results are consolidated into one report per patient and compared with previous findings. Different software user levels provide a hierarchical review of results, thus increasing security. All fluorescence images and reports are digitally archived. The software can be fully integrated into existing laboratory software (LIS) for a streamlined laboratory routine. The infection parameters complement established EUROPattern applications, such as the fully automated evaluation of ANA, ANCA, Crithidia luciliae, recombinant-cell and antigen-dot IFA.

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C419 Shimadzu

Benchtop MALDI TDF mass spectrometer

The new MALDI-8020 complements Shimadzu’s MALDI family. The linear benchtop time-of-flight mass spectrometer serves various applications in the positive ion mode, such as analysis of proteins, peptides or polymers. It is ideal for researchers developing MALDI-based diagnostic methods, and for routine labs carrying out quality control and fast analysis of intact samples. The MALDI-8020 is fast and accurate, has a high resolution and its compact size makes it fit in any laboratory. The robust design promises reliable analysis and low maintenance. With a mass range of 1-500,000 Da, a mass resolution of more than 5,000 (for ACTH18-39, m/z 2,465), a mass accuracy of < 20 ppm after internal calibration and a sensitivity of 250 amol (Glu-Fib, m/z 1,570), the MALDI-8020 achieves the same specifications as the more advanced version, the Axima Assurance for high throughput screening.  Thanks to its small dimensions of 450 x 745 x 1,055 mm and weight of 86 kg, the new MALDI-8020 fits on any lab workbench. The oil-free diaphragm pump and a turbo pump ensure reliable and low-noise operation (< 55 dB).
Extra-fast motors drive the highspeed stage. Motor installation outside the vacuum reduces the volume to be evacuated, so pumping time after changing of sample is the fastest on the market: around 90 seconds. The 200 Hz solid-state laser allows further optimization of the analysis time. The typical Shimadzu wide-bore ion optics increase ion transmission and reduce the likelihood of contamination. If the source is nevertheless contaminated, it can be cleaned within ten minutes using the UV laser-based TrueClean. The MALDI Solutions software provides intuitive and easy operation, and includes interfaces for evaluating polymer, protein and oligonucleotide spectra. SampleStation, AuraSolution and QC Reporter offer various options for automated lab routines. During sample preparation, data can be collected with the SampleStation software. The barcode reader integrated into the mass spectrometer enables automated measurement using AuraSolution. The QC Reporter software allows specification of different criteria that can be used for automatic evaluation of the analyses. Data is stored in a Microsoft® SQL database with automatic backup. Personalized user logins can be used to document quality control, and different levels can be assigned to individual users. In this way the user is prepared for potential audits.
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C420 DSM Pentapharm

UFH monitoring kit

Pefaclot UFH is a powerful and economic kit to monitor unfractionated heparin (UFH) in patient plasma samples. It has been outlined in several studies that Pefaclot UFH shows excellent reproducibility, accuracy and lot to lot consistency. Pefaclot UFH shows superior accuracy when compared to aPTT and excellent correlation to anti-FXa measurement at a much lower cost(1). It has been shown that Pefaclot UFH routine monitoring was associated with a significantly (p=0.035) reduced daily dose of administered UFH (median 27’000U/day with aPTT vs 25’000U/day with Pefaclot UFH)(2). Data suggest that monitoring with Pefaclot UFH is analytically more accurate and allows more precise dosing. The higher precision and reliability during the induction phase but also for dosing adjustment may result in a reduced number of venipunctures.  As a consequence, the obtained results lead to an overall shorter turnaround time for UFH administration compared to aPTT. Furthermore, the reduced number of tests needed during UFH administration reduces the time spent for lab technicians. The improved UFH administration with reduced doses of needed UFH has the potential to reduce the bleeding risk as well as the risk of developing HIT (heparin induced thrombocytopenia) for patients because of the lower exposure to UFH. In addition to fewer tests being performed, Pefaclot UFH may lead to even more savings as a consequence of lower doses of UFH being administered and fewer blood collection tubes and other consumables. The potential of lower bleeding risk may also reduce the overall duration of the hospital stay. Pefaclot UFH relies on the activation of plasma at the level of the prothrombinase complex and measures the clotting time in seconds. The clotting time is then directly linked to the UFH concentration in the sample. Pefaclot UFH is optimized to give strong clotting signals on optical instruments, but also demonstrates excellent reproducibility on mechanical instruments. It can be applied to all major routine analysers (e.g. from Stago, Siemens, Sysmex, Instrumentation Laboratory).

References
1. Bürki S, Brand B, Escher R et al. Accuracy, reproducibility and costs of different laboratory assays for the monitoring of unfractionated heparin in clinical practice: a prospective evaluation study and survey among Swiss institutions. BMJ Open 2018:8:e022943
2. Korte W, Graf L, Knöpfel C. Replacing the aPTT for monitoring of unfractionated heparin with the Prothrombinase induced Clotting Time (PiCT) – significant influence on dosing. GTH 2017 (Abstract 663)

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C424 Diagenode

All-in-one instrument for molecular diagnostics

The geneLEAD VIII, manufactured by PSS and distributed by Diagenode Diagnostics in Europe, is a new all-in-one automated molecular diagnostics platform designed for carrying out small series of tests (1,000 to 4,000 tests/year), from nucleic acid extraction to patient result in 1,5 hour. This instrument can independently perform up to 8 different real-time PCR tests, without or with extraction validated on whole blood, serum, plasma, urine, CSF, swab, sputum and stool. Combining expertise in the development of molecular diagnostic assays acquired over the last 14 years, Diagenode Diagnostics presents here the first in a range of multiplex tests for the geneLEAD VIII, focused on respiratory and gastrointestinal infections, including Influenza A & B virus, together with respiratory syncytial virus (RSV), Mycobacterium tuberculosis complex, Legionella pneumophila & spp, Adenovirus (mid-2019), Bordetella pertussis & parapertussis (late 2019), Norovirus I / II & Rotavirus (late 2019) and Mycoplasma pneumoniae (2020). The geneLEAD VIII is also compatible with Laboratory Developed Tests (LDT) based on real-time PCR and other detection chemistries. The geneLEAD VIII represents a unique CE-IVD solution which is ready for accreditation, easy-to-use and allowing workflow optimization with the middle-to-high-throughput automated systems in molecular diagnostics laboratories.

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HbA1c assay

DiaSys offers a new enzymatic HbA1c assay – HbA1c net FS – for diagnosis and long-term monitoring of diabetes. This innovative test is setting new standards for accuracy through its outstanding specificity and excellent precision. HbA1c net FS delivers results equivalent to HPLC. Interferences  by hemoglobin variants or other blood components are minimized. The HbA1c net FS assay is standardized against the IFCC reference method and traceable to DCCT/NGSP. Fully automated handling on clinical chemistry platforms including onboard hemolysis allows convenient management of daily workloads.

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trimero CLI 180919 doc image

Urinary free light chain assays for BN™ nephelometric systems

KLoneus®, the TRIMERO’s new generation of Kappa and Lambda Free Light Chain assays, based on polyclonal specific antibodies, have been developed specifically to assay “neat” urine samples on Siemens’ BN™ nephelometric systems, by particle enhanced nephelometric method, with antigen excess control using the pre-reaction feature.
In order to ensure lot to lot traceability, values have been referred to the European Reference Material ERM-DA470k/IFCC (Institute for Reference Materials and Measurements, IRMM).
KLoneus® results, with excellent repeatability, correlate well with the quantification by densitometry of the Bence Jones proteinuria.
Other available assays for Siemens’ BN™ nephelometric systems include 
C1q Complement, C5 Complement, C3 pro-activator (Factor B), IgD (with pre-reaction feature)

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Greiner New Logo Greiner Bio One resized 01

Greiner Bio-One has a new logo

Greiner Bio-One, a division of Greiner AG specializing in the development, production and distribution of high-quality plastic laboratory products, is proud to announce that it has changed its logo on its website and on all its existing social media channels.
The new logos of all Greiner divisions were presented in September 2018 at the 150-years-anniversary gala in Kremsmünster (Austria) where the company is headquartered. The new Greiner Bio-One logo was developed with the aim of presenting Greiner AG visually more strongly as a group, without restricting the visual and perceived independence and autonomy of the divisions. Since this change is very time-consuming and many areas and content types are affected, it will take place in several stages over a period of up to five years. www.gbo.com
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T2 Biosystems Candida Panel

Rapid diagnostics from whole blood for bacterial and fungal pathogens

T2 Biosystems’ T2Bacteria® and T2Candida® Panels are the first and only FDA-cleared and CE-marked tests that identify the most serious bacterial and fungal pathogens directly from blood sample in just three to five hours, without waiting for a positive blood culture —which can take one to six or more days. These capabilities allow for faster species identification, enabling the potential for faster targeted treatment, de-escalation of empiric therapy and improved patient outcomes.
All T2Direct DiagnosticsTM panels are run on the T2Dx® Instrument using a patient’s blood sample with validated clinical sensitivity of 91 to 96% and specificity of 98 to 99%. The direct from blood capability is enabled by the proprietary T2MR-powered T2Dx® Instrument which can detect organisms at concentrations as low as 1 CFU/mL. This represents a thousandfold increase in sensitivity compared to products that detect species from positive blood culture bottles where the number of cells is typically in the range of 10,000 to 10,000,000 CFUs/mL.
T2 Biosystems recently received FDA Breakthrough Designation for the T2ResistanceTM Panel, a diagnostic panel that can detect 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample in 3 to 5 hours. The T2Resistance Panel is also run on the T2Dx instrument and is expected to be CE-marked and available in Europe by the end of 2019, and offered as a Research Use Only product in the United States before yearend.  
T2 Biosystems will showcase its latest innovations at ECCMID at Booth #1.22.

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C415 Awareness Chemwell APAC 19

Automated RPR Syphilis Analyzer – ChemWell® RPR

The FDA-cleared ChemWell® RPR replaces the manual labor-intensive and subjective visual RPR reading with a fully automatic, 190 results-per-hour process that objectively interprets and stores photographic images. Over the years and around the world many high throughput labs have already given up the advantages of non-treponemal screening, replacing it with more expensive treponemal ELISA testing simply to take advantage of automation. The compromise is no longer necessary.

Automated ChemWell® RPR allows laboratories to use the US CDC recommended traditional nontreponemal screening algorithm instead of the higher-cost and complicated reverse algorithm while reducing hands-on time by 92%, compared to a manual RPR test.

The innovative test system was developed in cooperation with Arlington Scientific Inc. (Salt Lake City, Utah USA) who is selling in North America and Europe under the brand name Evolution. Awareness Technology will supply the rest of the world through its distribution and technical service channels.  

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Randox QC Webvertorial CLI April 2019 IMAGE

Molecular IQC and EQA for infectious disease testing

Designed to meet the demands of today’s molecular diagnostics laboratory and laboratories carrying out nucleic acid testing, our range of Molecular IQC and EQA comprises hundreds of characterized viral, bacterial and fungal targets. These targets cover a wide range of transplant associated diseases, respiratory diseases, blood borne viruses, sexually transmitted infections, gastro-intestinal diseases and central nervous system diseases amongst others ensuring our molecular IQC and EQA range covers the full laboratory portfolio. Our samples are manufactured using only the highest quality material and the availability of whole pathogen samples ensures the performance of the patient sample is mimicked throughout.
https://www.randox.com/product-spotlight-molecular/
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