EKF to highlight new Glycated Albumin assay kit at AACC 2018

EKF Diagnostics, a global in vitro diagnostics company, announces that at Booth #3880 at the AACC 2018 Clinical Lab Expo, it will highlight a new Stanbio Chemistry Glycated Albumin (GA) assay kit and its newly FDA-cleared DiaSpect Tm hemoglobin point-of-care analyzer. Located in Chicago, IL, from July 31st to August 2nd, AACC is the world’s largest exposition for clinical laboratory products and services.

The Stanbio GA assay has received FDA 510(k) clearance for sale in the United States. 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 immediately after the start or during an alteration in diabetes treatment, where measurement of GA can confirm blood glucose changes throughout just 2 to 3 weeks. It is also helpful for prognosis in hemodialysis patients and during pregnancy, when HbA1c may provide an insufficient indication of glycemic levels.

The Stanbio Chemistry GA assay utilizes an enzymatic method with liquid reagents, eliminating the need for 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, using 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 demonstrate the ease of use of its newly FDA 510(k)- cleared and CLIA-waived DiaSpect Tm hemoglobin analyzer. DiaSpect Tm is a handheld, reagent-free system, ideally suited and cleared for use in point-of-care (POC) and Certificate of Waiver settings, including physicians’ offices, clinics, and other non-traditional laboratory locations.

The analyzer’s simplicity of use means that it is suited for a range of settings and can be operated by a variety of healthcare personnel with minimal training. DiaSpect Tm analyzes whole blood from a sampling microcuvette 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 about one second after the microcuvette is 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 Tm is an ideal point-of-care (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 a shelf life of up to 2.5 years, even after opening, and are unaffected by temperature and humidity fluctuations. In addition, its ‘always-on’ technology enables professionals to start using the device immediately. The rechargeable internal battery, which provides up to 40 days or 10,000 tests of continuous use, offers the flexibility of not needing a power source for weeks at a time.

For more information about the FDA (510k) -cleared Stanbio Chemistry GA assay, as well as the FDA (510k) -cleared and CLIA-waived DiaSpect Tm hemoglobin POC analyzer, please see www.ekfusa.com. For complete information on the EKF Diagnostics Group, please visit www.ekfdiagnostics.com.