EKF Diagnostics, an international in vitro diagnostics company, announces that it will be highlighting a new Stanbio Chemistry Glycated Albumin (GA) assay kit and its newly FDA cleared DiaSpect Tm hemoglobin point of care analyzer on Booth #3880 at the AACC 2018 Clinical Lab Expo. Located in Chicago, USA, from July 31st to August 2nd, AACC is the world’s largest exposition for clinical laboratory products and services.
The Stanbio GA assay has been awarded FDA 510(k) clearance for sale in the USA. GA is a sensitive marker for intermediate glycemic control in diabetes and can fill the gap between long-term and short-term measurements of blood glucose status. This is particularly useful just after the start or during an alteration in diabetes treatment, where measurement of GA can confirm blood glucose changes over just 2 to 3 weeks. It is also useful for prognosis in hemodialysis patients and during pregnancy when HbA1c may provide an insufficient indication of glycemic levels.
The Stanbio Chemistry GA assay uses an enzymatic method with liquid reagents and requires no preparation. It can be used on compatible open channel clinical chemistry analyzers and expresses results as a ratio of Glycated Albumin to Albumin in mmol/mol from a small amount of blood serum. GA accurately reflects the latest blood glucose status as it is found throughout the body and is a type of protein that can readily be glycated.
Also at AACC, EKF will be demonstrating the ease of use of its newly FDA 510(k) cleared and CLIA waived DiaSpect Tm hemoglobin analyzer. DiaSpect Tm is a hand-held and reagent free system, ideally suited and cleared for use in point of care (POC) and Certificate of Waiver settings, including physician’s offices, clinics and other non-traditional laboratory locations.
The analyzer’s simplicity of use means that it is suited to a range of settings and can be operated by a variety of healthcare personnel with a minimal amount of training. DiaSpect Tm analyses whole blood from a sampling microcuvette that has been designed to collect a blood sample from any angle without forming air bubbles. This feature has the benefit of minimizing the need to repeat the testing procedure. Lab quality hemoglobin results are delivered in about one second of the microcuvette being placed in the analyzer. This makes the DiaSpect Tm the world’s fastest hemoglobin analyzer and ideal for efficient patient health checks and anemia screening at the POC.
The DiaSpect is an ideal POC analyzer as it is palm-sized, lightweight and easily transportable. It can be used in any screening setting, even in challenging climatic environments. This is because its reagent-free microcuvettes have up to 2.5 years shelf life, even after opening, and are unaffected by temperature and humidity. In addition, its ‘always-on’ technology enables professionals to start using the device immediately and the rechargeable internal battery, which provides up to 40 days/10,000 tests continuous use, offers the flexibility of not needing a power source for weeks at a time.
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