The Tosoh G8 (Tosoh Automated Glycohemoglobin Analyzer HLC-723G8) from Tosoh Bioscience Inc has received FDA clearance to be used as the first high-performance liquid chromatography (HPLC) instrument to measure HbA1c levels for the diagnosis of diabetes. The device was approved for diabetes monitoring in 2008.

Unlike other HbA1c testing methods, HPLC methodology enables users to ensure accuracy by visually identifying hemoglobinopathies that may interfere with test results. In proficiency tests, the Tosoh G8 has demonstrated high pass rates and CVs of less than 2%. “Having such a high level of precision gives you the confidence that you’re getting the right result every time you test,” says Ranka Milojkovic, senior HPLC product manager for Tosoh Bioscience.

The system offers HbA1c analysis time of 1.6 minutes, touch-screen navigation and automatic start-up, and a footprint of 21 inches x 19 inches x 20 inches. Flag level capabilities guarantee high-quality reporting, and the G8 eliminates sample pretreatment with direct primary tube sampling and cap piercing. Available in both 90- and 290-sample loader models, the device runs primary and secondary tubes in the same rack, allowing continuous loading of different-sized tubes.

For more information, visit Tosoh Bioscience Inc.