At the 2018 annual meeting of the American Association for Clinical Chemistry (AACC), global in vitro diagnostics manufacturer EKF Diagnostics, Cardiff, UK, highlighted its new Stanbio Chemistry Glycated Albumin (GA) assay kit and its newly FDA-cleared DiaSpect Tm hemoglobin point-of-care analyzer.
EKF Diagnostics’ DiaSpect Tm hemoglobin point-of-care analyzer.
The Stanbio GA assay has FDA premarket notification (510(k)) clearance for sale in the US market. GA is a sensitive intermediate-term marker for glycemic control in diabetes and can fill the gap between long-term and short-term measurements of blood glucose status. Such an intermediate-term marker 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. According to the company, GA 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 be readily glycated.
At the AACC meeting, EKF also demonstrated its easy-to-use and newly FDA-cleared and CLIA-waived DiaSpect Tm hemoglobin analyzer. DiaSpect Tm is a handheld and reagent-free system, suited and cleared for use in point-of-care (POC) and certificate of waiver settings, including physician’s offices, clinics, and other nontraditional laboratory locations.
EKF Diagnostics’ glycated albumin graph.
DiaSpect Tm analyzes 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 within about 1 second of the microcuvette being placed in the analyzer. This makes DiaSpect Tm the world’s fastest hemoglobin analyzer, suitable for efficient patient health checks and anemia screening at the point of care. While 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.
The DiaSpect Tm is palm-sized, lightweight, and easily transportable. It can be used in any screening setting, even in challenging climates. Its reagent-free microcuvettes have a shelf life of up to 2.5 years, even after opening, and are unaffected by temperature and humidity. In addition, its ‘always-on’ technology enables professionals to start using the device immediately. The unit’s rechargeable internal battery provides sufficient power for up to 10,000 tests or 40 days of continuous use, eliminating the need for access to an external power source for weeks at a time.
For more information, visit EKF Diagnostics.
