Tosoh G8 HPLC Analyzer For Diabetes Monitoring And HbA1c Testing Cleared By FDA

Main Category: Diabetes
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 02 Oct 2008 - 5:00 PDT

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The Tosoh G8 (Tosoh Automated Glycohemoglobin Analyzer HLC-723G8) has been cleared by the FDA. Continuing Tosoh's legacy of extraordinary precision, the G8 provides pinpoint accuracy with the industry's lowest CVs of less than 2%. HPLC Product Manager Ranka Milojkovic says: "The instrument-reagent system utilizes the gold standard ion-exchange method of HbA1c levels testing to effectively monitor glycohemoglobin in diabetes patients."

With a compact footprint of 21"w x 19"h x 20"d, the G8 fits easily in most laboratory environments. The G8 provides fast results with an HbA1c analysis time of only 1.6 minutes. Simple touch-screen operation, automatic start-up and daily maintenance make the system extremely user-friendly.

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 easily adapts to changing laboratory workloads by offering a choice of either a 90 sample loader or a 290 sample loader. With the optional LA model linked via a sample belt line, the G8 can handle a massive workload.

Feature enhancements include a new calibration check function with a pop-up window that displays standard values during calibration. Features also include a flag check function with user-selectable levels, buffer monitoring and an automatic prime function. Tosoh designed G8 functions from the user perspective, enhancing overall safety and convenience of operation.

Tosoh's ion-exchange high performance liquid chromatography (HPLC) is the gold standard for HbA1c diabetes measurement. Ion-exchange HPLC was used in the Diabetes Control and Complications Trial in the United States.

The Tosoh G8 provides direct determination of stable HbA1c. The system is used for in vitro diagnostic measurement of HbA1c in blood specimens. The G8 uses a non-porous column and microcomputer technology to quickly and accurately measure the stable portion of HbA1c as a percentage of the total amount of hemoglobin present in the sample. The G8 provides accurate and precise separation of HbA1c from other hemoglobin fractions. Off-line pretreatment is not required and there is no interference from the labile portion of HbA1c.

The analyzer dilutes the whole blood specimen with Hemolysis & Wash Solution and then injects a small volume of the treated specimen onto the TSKgel Glyco HSi Variant Column. Separation is achieved by utilizing differences in ionic interactions between the cation exchange group on the column resin surface and the hemoglobin components in a step gradient elution. The hemoglobin fractions (designated as A1a, A1b, F, LA1c+, SA1c, A0, and H-V0, H-V1, H-V2) are subsequently removed from the column material by performing a step-wise elution using Elution Buffers HSi Variant 1, 2, and 3 that have specific salt and pH concentrations.

The separated hemoglobin components pass through the LED photometer flow cell where changes in absorbance are measured at 415nm. The G8 software integrates and reduces the raw data, and then calculates the relative percentages of each hemoglobin fraction. The print- out consists of the numerical results and chromatogram. This represents the changes in absorbance versus retention time for each peak fraction. An analysis requires only 1.6 minutes.

Tosoh Bioscience is a world leader in the development of diagnostic products for HPLC and diabetes monitoring. For more information, contact Tosoh Bioscience at (800) 248-6764 or visit http://www.diagnostics.us.tosohbioscience.com.

The Tosoh G8