EKF Diagnostics has announced the successful evaluation of its Quo-Lab® point-of-care HbA1c analyser by the European Reference Laboratory for Glycohemoglobin. In a recently published paper. The reference laboratory’s evaluation study assessed HbA1c (glycated hemoglobin) POC devices using international quality targets, posing the question ‘Are they fit for purpose?’ Out of 30 available on the market and the four that agreed to participate, only EKF’s Quo-Lab and one other analyser passed the same stringent quality criteria as laboratory analysers, achieving excellent analytical performance.
The study aimed to evaluate the four POC HbA1c instruments according to Clinical and Laboratory Standards Institute (CLSI) protocols and how they performed when different criteria were applied using four certified IFCC and NGSP secondary reference measurement procedures (SRMPs). The reference laboratory study confirmed there was minimal bias between Quo-Lab and the mean of four SRMPs, it also passed all relevant performance criteria going far beyond what is required for NGSP and IFCC certification.
Notably, Quo-Lab showed no consistent clinically significant interference from the common hemoglobin (Hb) variants HbAS, HbAC, HbAD, HBAE and elevated A2. It also easily met imprecision criteria, achieving a ≤2.4% CV in IFCC SI units and ≤1.7% CV in DCCT units which represents a significant improvement on previous studies.
Commenting on the successful European Reference Laboratory for Glycohemoglobin evaluation, Gavin Jones, Diabetes Product Manager, EKF Diagnostics said, “The excellent performance that Quo-Lab has demonstrated in this latest study confirms that it is very definitely fit for purpose, delivering reliable HbA1c results in a range of settings. Quo-Lab® HbA1c is a desktop analyser designed specifically to meet the needs of diabetes clinics and laboratories in settings that demand low cost of operation and ease of use. From a simple semi-automated procedure, Quo-Lab provides test results within four minutes from a venous or finger prick blood sample of just 4 μLwww.ekfdiagnostics.com
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Thales introduces the latest Pixium Portable 3543 DR, the first ever truly standalone device with embedded patient identification working in auto-detection mode without connection to any
external device. This patented product allows for images to be taken at the bedside. By simply scanning the patient’s ID bracelet the images are linked to the patient and can be stored directly on the detector. An easy-reading display indicates the number of images taken per patient and the total number of images stored in the device for an ulterior upload into the radiology room.
Ever since the launch of the Pixium Portable 3543 DR in 2016, the company has been researching on how to ensure images are seamlessly assigned to patients and easily stored in a way that allows doctors and technicians to examine multiple patients easily. By working in auto-detection mode, the new Pixium Portable 3543 DR does not need to connect to any external devices, making it easier and quicker to operate than legacy portable systems. This makes for higher efficiencies since practitioners can examine multiple patients at minimal dose, anywhere in the hospital. Thanks to its optimized workflow, errors and stress are minimized and time and money are saved. Images and patient files can be uploaded directly to the radiology room, eliminating the need for numerous CR cassettes and answering the growing need of reducing system total cost of ownership.  

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Siemens Healthineers recently announced the new RAPIDPoint 500e blood gas system, their latest solution in critical point-of-care testing. The new system generates blood gas, electrolyte and metabolyte results used to diagnose and monitor critically ill patients typically in the intensive care unit, operating room or emergency room. The RAPIDPoint 500e blood gas system is available now in all countries requiring the CE mark. Developed with extensive customer feedback, the system is designed to elevate confidence in patient results with Integri-sense technology, streamline workflow with improved simplicity and raise the bar in data security. Cybersecurity is becoming a key operational factor. Healthcare providers must protect confidential operator and patient information.
The RAPIDPoint 500e blood gas system incorporates Integri-sense technology, a comprehensive series of automated functional checks designed to deliver accurate test results at the point-of-care. Integri-sense technology combines three levels of automatic quality control (AutomaticQC), multiple calibration routines and advanced software algorithms to generate reliable and clinically actionable test results. It also integrates seamlessly into hospital networks with the Siemens Healthineers Point of Care Ecosystem which offers convenient, remote management of operators and devices located across multiple sites.

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Two studies have been published that successfully evaluate the use of its Yumizen H500 hematology analyser for point-of-care testing (POCT) to enhance the care of oncology patients. With near-patient, full blood count results, patients undergoing chemotherapy can receive treatment without delay and greatly reduce their hospital/clinic exposure times. Both UK-based studies were presented at the recent ISLH 2018 (International Symposium on Technical Innovations in Laboratory Hematology) in Brussels.
The evaluation studies were performed by the Cardiff and Vale Health Board (CAVHB), University Hospital of Wales [1] and the Spire Bushey Laboratory, London [2] and can be viewed on the HORIBA Medical global website. Both studies demonstrated that the compact, easy-to-use analyser delivered at the POC clinically key parameters that showed exceptional correlation with larger laboratory-based hematology analysers. Blood samples from oncology patients may be abnormal, having low counts and atypical blood cells, therefore it is essential that near-patient testing does not compromise the clinical integrity of results.
The studies both found that in addition to speed and ease of use, the Yumizen H500’s functionality and audit systems fully adhere to ISO standards (both 15189:2012 and 22870:2016) with the same internal quality controls as larger analysers. This in turn ensured detailed, accurate results for timely and sound clinical decision making.
For example, the Cardiff study concluded that by using the Yumizen H500, “In CAVHB the potential for clinical improvement is potentially vast, average TAT (vein to report) for FBC is ~4 hours, this could be reduced to <15 minutes. This would mean that in certain patient groups (thrombocytopenic and anemic) they can request blood components earlier and be transfused more quickly, this in turn would reduce hospital stays. In neutropenic patients their treatment options could be considered more readily and reduce hospital/clinic exposure time in those that would not be appropriate for chemotherapy.”  With just three reagents and an intuitive touch screen user interface, HORIBA Medical’s Yumizen H500 compact hematology analyser is designed for ease of use; yet it offers a range of clinically key parameters, including: 5-population WBC differential, red blood cell parameters and platelet count. This makes the Yumizen H500 most suitable for rapid blood counting for use in POC settings for pediatric care and chemotherapy patients, as well as from emergency care to the routine laboratory.
The two POCT studies presented at ISLH 2018 can be viewed at:
https://www.horiba.com/en_en/products/by-segment/medical/

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Senographe Pristina features an option to use a first-in-industry patient-assisted compression remote control to enable the patient, with the help of a technologist, to set the compression that feels right for her.
The handheld wireless remote control, called Pristina Dueta, allows patients to adjust the compression force after breast positioning. The technologist then guides the patient while she operates the remote control to adjust compression until she reaches an adequate compression level. The design strives to minimize women’s perceived pain and discomfort by giving them an active role in the application of compression.
In a patient survey conducted with 160 patients in two sites in Europe, 4 out of 5 patients who received their mammogram on the Pristina coupled with Pristina Dueta found it improved the comfort of their exam. Pristina has other design enhancements to improve exam comfort. The gentle, rounded corners of the image receptor or “bucky”, where the woman places her breasts, helps reduce discomfort and anxiety. It is also thinner so there’s less hard metal pushing into the patients’ ribs. The design also changes the way the patient is standing: Instead of requiring patients to grab conventional handgrips, which may cause tensing of pectoral muscles and therefore make it harder for the technologist to acquire clear images, patients can instead lean comfortably on armrests and relax their muscles to simplify positioning, compression and image acquisition.
By improving patient comfort, technologists can focus on precise positioning, potentially making the exam easier and faster. Poor positioning is a leading cause of retakes, and the lack of proper positioning may decrease mammography sensitivity. Pristina also includes the latest in 3D digital mammography technology, also known as digital breast tomosynthesis, which delivers superior diagnostic accuracy at the same low dose as a 2D mammography exam – and the lowest patient dose of all FDA-approved 3D mammography systems.
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