BioSystems is introducing new models of semi-automated coagulometers aimed at small to medium-sized laboratories. The COAX family includes 1, 2 or 4 optical channel devices. Operation is very intuitive, with a high quality colour touchscreen, allowing easy patient data management. Including state-of-the-art optics, the instrument uses disposable cuvettes with automatic light level adjustment at each channel to avoid optical disturbances, and a high optical resolution that allows high accuracy. The absorbance of the reaction is monitored continuously so time control starts immediately after reagent addition (thus, not requiring special pipettes as triggers). Also, thanks to their neat design making them easy to clean, as well as their minimum maintenance requirements, the instruments meet the typical needs of small and medium-sized labs. For all devices in the COAX series, BioSystems offers a complete range of the most common tests: PT, APTT, FIB and TT, validated lot to lot to achieve maximum performance. Besides, COAX2 and COAX4 are able to read additional tests using either chromogenic or latex reagents, such as individual coagulation factors, Antithrombin III, Protein C or D-Dimer.

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Hologic’s Panther Fusion Bordetella assay has received CE mark in Europe. This assay, the latest in a growing menu of Panther Fusion and Aptima assays, brings full automation, efficiency and excellent assay performance to Bordetella detection. The Panther Fusion system retains all the key benefits of the Panther platform, including full sample-to-result automation, and is suitable for any size laboratory.
The Panther Fusion Bordetella assay is a real-time PCR assay for the detection and differentiation of Bordetella pertussis (B.
pertussis) and Bordetella parapertussis (B. parapertussis) from nasopharyngeal swab specimens collected from symptomatic patients.Laboratories can combine cervical and sexual health, virology, respiratory, hospital-acquired infections, and Open Access tests on the Panther Fusion system, running up to 32 different assays at the same time. The system offers labs the potential to process up to 500 Panther Fusion and Aptima assays in an 8-hour period.
Panther Fusion is available as a full system, or the Panther Fusion module can be attached to existing Panther systems in the field to extend testing capabilities. The Panther Fusion module adds the capacity to run PCR (polymerase chain reaction) assays in addition to tests based on TMA (transcription-mediated amplification), the proprietary Hologic chemistry that powers the company’s Aptima brand. Key system benefits include the ability to run multiple tests from a single sample, random and continuous access, sample processing with rapid turnaround time, continuous loading, and STAT capabilities.
The Panther Fusion assays utilize ready-to-use, unit-dose lyophilized reagents, which have 60-day on-board stability to help reduce waste and the need for manual reagent preparation. Diagenode, a leading diagnostics assay provider based in Liege, Belgium and New Jersey, USA, was a principal partner in developing the Panther Fusion Bordetella assay in collaboration with Hologic, and is the manufacturer of the kit.

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A new CE-labelled Uromodulin ELISA allows measurement of the uromodulin concentration in serum or plasma, and represents a sensitive test for kidney function loss. Uromodulin is a glycoprotein which is synthesized exclusively in the kidneys and subsequently secreted. When renal function is impaired, the uromodulin concentration in the serum sinks rapidly. Thus, renal disorders can be detected at a very early stage, even when there are few symptoms. Uromodulin determination supplements established kidney function markers such as creatinine. Moreover, it enables detection of renal insufficiency in the creatinine-blind area in the initial stages of kidney disease. Uromodulin measurement is also suitable for monitoring kidney vitality during therapy, predicting clinical outcome after kidney transplantation and enhancing risk prediction for cardiovascular diseases. In the ELISA, uromodulin is detected using microplates coated with anti-uromodulin antibodies. The uromodulin concentrations are established using a simple cut-off-based interpretation (normal value in health adults around 200 ng/ml). External factors such as body weight, nutrition or muscle mass do not need to be factored into the results by additional calculations, as with classic markers. The fast and simple test procedure takes less than 3 hours and is fully automatable on all open ELISA processers.

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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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RPS Diagnostics recently announced an updated CE mark of its FebriDx test, clearing the way for its immediate launch in the European Union and all countries recognizing the CE mark. FebriDx is a rapid, accurate, and simple to use point-of-care test that provides clinicians with a 10-minute assessment of the body’s immune response to an acute respiratory infection (ARI) directly from a fingerstick blood sample. The single use, disposable test identifies patients who have a clinically significant underlying infection and aids in the differentiation of viral and bacterial ARIs through the rapid detection of both Myxovirus resistance protein A (MxA) and C-reactive protein (CRP). MxA is an intracellular protein that becomes elevated in the presence of acute viral infection and CRP is a nonspecific inflammatory protein that is elevated in the presence of any clinically significant infection. Thus, unlike a standalone CRP test, MxA confers specificity to the test through the combined interpretation of the results.
The updated FebriDx test incorporates an all-in-one plastic housing technology that includes a built-in safety lancet, blood collection and delivery system, and integrated push button buffer delivery feature, which together, improve test convenience. The FebriDx test requires no additional equipment to perform or to interpret results. Through comprehensive analytical testing as well as a multicentre precision and reproducibility study, RPS Diagnostics successfully demonstrated equivalency to the previously CE-marked version of the product.
The timely FebriDx test results enable clinicians to formulate a targeted clinical management and therapeutic decision plan during the initial patient encounter. Antibiotic misuse is a complex global problem that leads to antibiotic resistance, avoidable adverse events, and contributes to rising healthcare costs, largely driven by diagnostic uncertainty and patient pressure. More than 50% of all antibiotic prescriptions are unnecessary and are generated in the outpatient primary and urgent care setting. In a recent study in the United Kingdom, FebriDx was shown to alter clinical management decisions in 48% of patients tested, and to reduce unnecessary antibiotic prescriptions by 80%. Each day that goes by without the implementation of a cost-effective solution is exacerbating the current global antibiotic crisis.
It is equally important not to miss treating an underlying bacterial infection as it is withholding unnecessary antibiotics from patients with clinically insignificant or viral infection. While most research and investment over the past decade has focused on rapid molecular testing to identify specific pathogens, FebriDx utilizes the body’s own immune system to provide a broad, fast, accurate, and cost-effective method to identify patients who may benefit from appropriate antibiotic therapy.

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