EKF launches FDA CLIA-waived β-ketone and glucose POC analyzer

EKF Diagnostics, the global in vitro diagnostics company, announces a new addition to its Diabetes Care portfolio in the U.S. The STAT-Site® WB is a dual-use whole blood β-ketone and glucose meter for professional use in managing diabetes. The new FDA CLIA-waived handheld analyzer reliably and efficiently delivers results within five to ten seconds. It can be used in point-of-care (POC) and Certificate of Waiver settings, such as physicians’ offices, clinics, and other non-traditional laboratory locations.

As a dual analyte measurement system, the STAT-Site® WB can quantitatively measure β-ketone (Beta-Hydroxybutyrate or BHB) from both fresh capillary and venous whole blood in 10 seconds. Additionally, it provides quantitative measurements of glucose in fresh capillary, venous, and neonatal whole blood within five seconds. Results are reported on its clear LCD screen, and up to 400 can be stored in memory; these can be downloaded using a simple mini USB cable.

The new system is straightforward and intuitive to use as it is reagent-free. It uses test strips to which whole blood is added directly. These are available either individually foil-wrapped or in a vial with a shelf life of six months once opened. The test strips are wide for easy handling, and a strip indication light on the analyzer guides the insertion process.

Further enhancing its ease-of-use, the STAT-Site® WB’s strip identification system automatically differentiates whether a blood glucose or a β-ketone test strip has been inserted. It will be analyzed accordingly via its auto-start function. Just 1 µL of whole blood is required for this analysis, and the system will detect and alert if insufficient blood is available. Additionally, an automatic strip ejection function prevents cross-contamination, making it easier for inexperienced users.

Accurate with excellent linear range, the STAT-Site® WB has a measurement range for β-ketone of 0.1 to 8.0 mmol/L and blood glucose of 10 to 600 mg/dL (0.5 to 33.3 mmol/L). Its wide hematocrit range is 10 to 70% for β-ketone and 20 to 70% for blood glucose. To ensure its accuracy, the system has auto QC identification and is calibrated using the Liquicolor® Beta-Hydroxybutyrate method. This is used by almost 1,300 hospitals in the USA to identify and monitor patients with diabetic ketoacidosis, amongst many other clinical applications.

“The introduction of STAT-Site® WB further enhances our diabetes care product range. EKF Diabetes Care strives to improve patient access to diabetes care diagnostics by providing affordable, easy-to-use technology, reducing the cost of long-term healthcare for the growing diabetic and pre-diabetic population,” said Gavin Jones, Head of Product Management, EKF Diagnostics. “Having ready and efficient access to lab-quality β-ketone and glucose results at the POC provides practitioners and patients with the essential information they need to make clinical or lifestyle decisions in seconds.”

Due to its FDA CLIA-waived status, the new STAT-Site® WB is initially only available for sale to the U.S. market. The product is currently undergoing the CE mark process. This whole blood β-ketone and glucose meter will be available for professional use in managing diabetes globally.