C351 Gonotec osmomat 3000

Single-sample freezing point osmometers

The Osmomat 3000 single-sample freezing point osmometer is especially designed for routine measurements in the medical field and is also very suitable for measurements in research. The instrument determines the total osmolality of aqueous solutions. It requires very small sample volumes and can thus be applied for extreme measuring tasks. Its rapidity allows serial measurements in a very short time.

A basic version of this instrument is also available for simple handling and precise measurements rather than automatic documentation. Measurements on the Osmomat 3000 basic have to be recorded by the operator, as it is not equipped with a printer nor with data output.

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EKF Quo Lab In use

EKF Diagnostics’ Quo-Lab analyser is setting new standards in HbA1c measurement

A study published in the Journal of Diabetes Science and Technology found that “Quo-Lab met all criteria” and “has no bias compared to the mean of four secondary reference measurement procedures.”*
Quo-Lab is a semi-automated analyser designed to meet the needs of diabetes clinics and labs that demand low cost of operation and ease of use. It provides HbA1c results in four minutes using a small drop of blood.
EKF has developed Quo-Lab in conjunction with industry experts to deliver a product that meets the tightening requirements of NGSP certification and CAP EQA criteria.
Find out what Quo-Lab can do for your practice today.
https://www.ekfdiagnostics.com/quo-lab.html
 
*Lenters-Westra E, English E. Evaluation of Four HbA1c Point-of-Care Devices Using International Quality Targets: Are They Fit for the Purpose? Journal of Diabetes Science and Technology. 2018; 12: 762-770.



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C372 Diazyme crop

2-reagent Vitamin D assay

Diazyme Laboratories, Inc. announced that the FDA has granted 510(K) clearance to market its two-reagent Vitamin D assay, the only fully automated two-reagent Vitamin D test for use on validated clinical chemistry analysers. Diazyme’s EZ Vitamin D assay is a universal fully automated Vitamin D test that is specifically designed for use on clinical chemistry analysers. This liquid stable, ready-to-use two reagent system measures total 25-hydroxy Vitamin D (25-OH Vitamin D2 + 25-OH Vitamin D3) levels. This assay enables clinical laboratories of almost any size to run Vitamin D test in house without the need for expensive specialized instrumentation. With no sample pre-treatment or pre-dilution steps required, this high-throughput liquid stable assay provides precise test results, is user friendly, cost effective and has excellent correlation to the existing commercial methods.

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beckman coulter life sciences logo

Flow cytometric casebook

Flow cytometric immunophenotyping is a rapidly evolving IVD technology which is establishing a place in the routine lab for the assessment of leukemia and certain lymphomas.  At the heart of the test is a panel of antibodies that can detect markers or antigens on the cells.  However, this depends on the accurate interpretation of complex patterns, determining whether a pattern is consistent (normal) or inconsistent with an expected population. To aid in this complex pattern recognition,  Beckman Coulter has developed a unique educational resource, the ClearLLab CaseBook. Users can also download the data to continue their diagnostic practice.
The casebook is based on the ClearLLab 5C reagents which were the first preformulated, IVD antibody cocktails for leukemia and lymphoma immunophenotyping to be granted de novo authorization by the Food and Drug Administration (FDA) for in vitro diagnostic use.  ClearLLab reagents simplify and standardize the process removing one of the limitations to flow cytometry gaining its place in the routine lab, and eliminating the need for a lab to manually prepare and design panels, a time- consuming process.
The ClearLLab 5C Casebook provides the clinical history of 16 patients, illustrating the progressive analysis of flow cytometric immunophenotyping data by means of numerous colour-coded illustrated scatter plots.  These first assess and then assign the cells before giving a detailed characterization of the aberrant population according to the presence or absence of antigens.  It includes patients with characteristic findings typical of various lymphoid and myeloid neoplasms as well as those with clinical and/or laboratory findings suggesting an underlying neoplastic process, but in which no immunophenotypic abnormality is identified.  Specimen types include peripheral blood, bone marrow, and lymph nodes. Each case concludes with an assessment of the immunophenotypic findings as well as potential pitfalls.
Flow cytometry has several advantages over immunohistochemistry in cancer detection.  This includes its ability to define distinct cell populations by their size and granularity, exclude weakly expressed surface antigens and measure several antigens at the same time with multi-colour analysis.

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beckman coulter logo

Remote instrument service application

Beckman Coulter recently announced the European launch of DxONE PROService, a custom remote-service application that enables laboratories to help ensure fast turnaround times for important patient test results through continuous instrument monitoring. DxONE PROService allows Beckman Coulter to work in collaboration with laboratories to identify potential system issues with alerts that notify of possible workflow disruptions. This helps to prevent circumstances that could compromise delivery of critical patient results and maximizes instrument uptime. The service securely channels performance information through Beckman Coulter’s proprietary data pipeline to a dedicated regional private cloud.
Through the secure, proprietary connection capabilities of DxONE PROService, laboratories can give Beckman Coulter service teams remote access to their instrumentation. Applying intelligent diagnostics, service professionals can take a forward-looking approach to identifying potential issues in advance, and proactively address them. Should issues arise, laboratory technologists and Beckman Coulter experts can engage in real- time troubleshooting and, if possible, fix issues remotely. If a service call is necessary, Beckman Coulter will have the information needed to expedite a resolution of the issue, ensuring laboratory operations are up and running as quickly as possible.
DxONE PROService meets the standard for the EU’s newly implemented General Data Protection Regulation (GDPR), which governs how the personal information of EU citizens is gathered, transferred and stored within the European Union. DxONE PROService uses encryption, VPN and authentication services, and dedicated regional private clouds that are in compliance with the GDPR.

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C384 Thermo best open

Compact refrigerators for secure and sustainable clinical storage

A new series of compact refrigerators has been specifically developed to address the need of clinical laboratories and patient care facilities for cold storage equipment that enable secure and energy-efficient storage of vaccines, medicines, lab kits and breast milk, while offering quiet operation and a small footprint. Powered by Phononic’s solid state cooling technology, the new TSG refrigerators have been designed to provide uninterrupted temperature stability and cleanroom-compatible readiness for reliable storage of the most sensitive materials. Furthermore, the systems offer whisper quiet operation at less than 35 dbA, meaning they can be placed in clinical laboratories, nurse’s stations, and even patient rooms and intensive care units, without disrupting the work environment and patient comfort. With ENERGY STAR-rated performance, the TSG Series refrigerators consume significantly less energy than similar models, meeting clinical settings’ sustainability objectives and reducing operating costs. In addition, as they feature fewer refrigeration components compared to other available units, they require only minimal maintenance and offer increased storage capacity. The solid state technology used in the TSG Series allows for minimal impact on the clinical environment through reduced operational noise and heat output, while the systems’ small size maximizes working space. As with the Thermo Scientific TSX Series of freezers and refrigerators, the new TSG Series uses environmentally-friendly refrigerants in line with global initiatives aimed at minimizing greenhouse gas emissions. Additionally, the systems feature an alarm capability, notifying users of temperature fluctuations, door ajar and power failure, enabling for corrective action to ensure ideal storage conditions are always maintained throughout the internal chamber. The TSG Series refrigerators are available in undercounter (TSG505) and countertop (TSG205) configurations to suit varying application needs.

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C388 Awareness Technology copy

Automated RPR syphilis analyser

Awareness Technology, Inc. has announced FDA clearance and release of ChemWell RPR for reliable and cost-effective syphilis screening. ChemWell RPR replaces the manual labour-intensive and subjective visual rapid plasma reagin (RPR) reading with a fully automatic, 190 results-per-hour process that objectively interprets and stores photographic images. This 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. RPR yields fewer false positives and is therapeutically useful unlike treponemal testing, The innovative 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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C393 Buhlmann

Fully automated calprotectin testing

Fecal calprotectin testing has historically been a challenging test. Sample preparation is smelly and time consuming; and the assays have previously taken a long time to run.
The CALEX Cap from Bühlmann already eased the sample preparation, providing rapid, clean and consistent preparation, offering a simplified workflow solution for fecal calprotectin extraction without the need to decant or further dilute samples. Now modifications to the blue and white caps at either end of the CALEX device enable them to be used on laboratory track systems for a truly automated hands-off approach to fecal calprotectin testing.     The white cap has been rounded so that once the stool has been sampled the CALEX can fit easily into the racks and pucks of laboratory track systems for front loading or full random access mode. The CALEX is then automatically identified from the barcode and centrifuged. The modification to the blue cap enables automated de-capping after which the CALEX is transported on the track to the appropriate analyser for calprotectin analysis using the Bühlmann fCAL turbo before being moved to the automatic sealer and storage area. Results are then automatically reported on the laboratory LIM system. Combined with the speed of result and wide assay range (20 – 8000µg/g) of the fCAL turbo, the new Track CALEX completely transforms the approach to Calprotectin testing.

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C389 Coris crop

Carbapenemase variants detection test

Surveillance and control of resistance to beta-lactam among gram-negative bacteria remains nowadays a big concern for microbiologists worldwide. Descriptions of OXA-48 associated infections are still revealing huge impact on antimicrobial treatment and patient morbidity. For clinical laboratories, OXA-48 and its variants represent the most challenging resistance mechanism to detect and are often under-detected by routine diagnostic methods. Multiple allelic variants of OXA-48 have been described, with diverse hydrolytic profiles. As an example, the single amino acid substitution and four amino acid deletion described in OXA-163 confer an increased hydrolytic activity against cephalosporins, coupled to a loss of resistance to carbapenems. This particular hydrolytic profile makes detection confusing. Treatment failures can impede patient recovery and favour the selection of new resistant strains. Until recently, efficient identification of OXA-163-expressing strains relied on gene sequencing, which is not practical for a clinical laboratory daily routine. The recently available immunochromatographic lateral flow assay developed by Coris BioConcept to specifically differentiate OXA-163 from OXA-48 proteins, replaces costly and lengthy genotypic methods. This phenotypic test is an easy-to-use and instrument-free test that provides a fast (15 minutes) and accurate (100%) identification of variants. Precise detection of other carbapenemases will be included in the test to reach a 5-parameters assay. This up-coming “RESIST-5” test commercialized by the same company is the ideal tool to precisely identify the most prevalent carbapenemase-mediated resistance mechanisms on a single phenotypical assay. Its use on a daily routine in healthcare facilities will enable a broader surveillance of worldwide-disseminating new carbapenemase variants and help clinicians in the daily patient care.

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C387 Euroimmun

Microarray for detection of polymorphisms in lactose intolerance

A DNA microarray based on EUROArray technology provides parallel detection of the two main polymorphisms associated with primary lactose intolerance (13910 C/T and 22018 G/A) in one test. Genetically-caused deficiency of the digestive enzyme lactase affects around 20% of Europeans and almost all adults in large parts of Asia.  According to current knowledge, homozygous carriers of the wild type variant (13910 C/C or 22018 G/G) develop lactose intolerance, while heterozygous carriers of the polymorphisms (13910 C/T or 22018 G/A) only show corresponding symptoms in stress situations or with intestinal infections. Homozygous carriers of the mutant variant (13910 T/T or 22018 A/A) are lactose tolerant as adults. These latter gene variants prevail especially in population groups with a long tradition of pastoralism, for example in Europe.  Primary lactose intolerance needs to be distinguished from the secondary (acquired) form, which can develop as a result of other gastrointestinal diseases and is often only temporary. Molecular genetic determination is able to differentiate the two forms, in contrast to classical diagnostic procedures such as the hydrogen breath test or blood sugar test which cannot distinguish the primary and secondary forms.
The EUROArray Lactose Intolerance Direct provides simple and fast detection of the two polymorphisms 13910 C/T and 22018 G/A, allowing confirmation or exclusion of primary lactose intolerance with high probability. In the case of positive results, homozygous and heterozygous states are differentiated. The assay can be performed directly on pre-treated whole blood, eliminating the need for time- and cost-intensive DNA isolation. Numerous integrated controls ensure high reliability of results, for example, by verifying that there are no other rare mutations in direct proximity to the tested positions which could interfere with the analysis. Data evaluation, interpretation and archiving are fully automated using the EUROArrayScan software, ensuring standardized, objective results. All EUROArray processes from sample arrival to report release are IVD validated and CE registered.

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