The Tosoh G8 (Tosoh Automated Glycohemoglobin Analyzer HLC-723G8) has been cleared by the FDA as an HPLC instrument to be used as an aid in diagnosis of diabetes and identifying patients who may be at risk for developing diabetes. The Tosoh G8 was initially cleared by the agency in 2008 as a diabetes-monitoring device. The intended use has now been expanded so the Tosoh G8 can be used for screening as well. The ADA Clinical Practice Recommendations state that HbA1c can be used to diagnose diabetes using a NGSP-certified method and a cutoff of HbA1c ≥6.5%.
Tosoh representatives say that the Tosoh G8 features flag level sophistication to ensure that highest-quality HbA1c results are being reported and has a compact footprint of 21″w x 19″h x 20″d; an HbA1c analysis time of only 1.6 minutes; touch-screen operation; and automatic start-up and daily maintenance. Sample pre-treatment is unnecessary, as the G8 utilizes direct primary tube sampling and cap-piercing. A variety of different-sized tubes can be loaded continuously. The operator can also run primary and secondary tubes in the same rack. The G8 offers a choice of either a 90-sample loader or a 290-sample loader.
Senior HPLC Product Manager Ranka Milojkovic says: “HbA1c is too important a test for you not to be able to see all that is behind the actual number. You can’t just trust that you have the right number; you have to be able to see it with your own eye.” Milojkovic also notes that the Tosoh G8 has demonstrated high pass rates and CVs of less than 2% in proficiency tests.
