HbA1c Testing

Tosoh Introduces the ST AIA-PACK HbA1c Assay on the AIA-360 and AIA-600II Immunoassay Analyzers

admin — Wed, 26 Jan 2011 22:28:07 +0000

South San Francisco, CA (Tosoh Bioscience, Inc.) — January 26, 2011 — Tosoh Bioscience, Inc., a pioneer in HPLC HbA1c testing has developed an HbA1c test that uses Tosoh’s well known “Unit Dose Test Cup” technology for the AIA-360 and AIA-600II analyzers, providing a complete solution for HbA1c testing.

The ST AIA-PACK HbA1c assay uses EDTA whole blood specimens and is available in the 10 minute incubation format. The final result is in HbA1c % and does not require separate measurements of total hemoglobin and HbA1c. The ST AIA-PACK HbA1c is directly traceable to the International Federation of Clinical Chemistry (IFCC) reference calibration. Calibrator values are provided in both IFCC and NGSP units. The ST AIA-PACK HbA1c is NGSP certified on the AIA-360 and AIA-600II analyzers.

The ST AIA-PACK HbA1c has been shown to be substantially equivalent to the HPLC method – Tosoh Automated Glycohemoglobin Analyzer HLC-723G7. The ST AIA-PACK HbA1c assay has no interference from variants HbC, HbD and minimal interference with HbS and HbE. HbF does not interfere with the assay result up to HbF concentrations of 10%. The ST AIA-PACK HbA1c has a within run precision of <2% and a total precision of <4%. The unit dose test cup and 90 day calibration stability help low volume HbA1c users to minimize costs and prevent reagent wastage.

Tosoh believes that HPLC is the gold standard for HbA1c testing and offers the ST AIA-PACK HbA1c as a cost effective solution for low volume laboratories to expand their immunoassay test menu without compromising quality.

Tosoh Bioscience, Inc. (TBI) provides highly sophisticated diagnostic systems for immunoassay and HPLC testing to doctor’s offices, hospitals and reference laboratories throughout the Americas. Based in South San Francisco, CA, TBI is a U.S. subsidiary of Tosoh Corporation which is headquartered in Tokyo, Japan. TBI is part of Tosoh Corporation’s Bioscience Division.

HbA1c Testing for Diabetes Monitoring on Tosoh G8 HPLC Analyzer

admin — Tue, 28 Apr 2009 09:06:23 +0000

(April 26, 2008) … Video: Utilizing the gold standard ion-exchange method of
hemoglobin A1c measurement, the Tosoh G8 HPLC Analyzer processes results quickly
with less than 2% CVs. The instrument’s reliability and precision provide
caregivers the confidence necessary to deliver the best diagnosis and treatment.

Tosoh G8 HPLC Analyzer

HbA1c testing: delivering HbA1c Test Results with Confidence

admin — Tue, 10 Mar 2009 23:57:34 +0000

March 11, 2009 – HbA1c testing: delivering HbA1c Test Results with Confidence. In 2007, CAP began using accuracy grading with an acceptable limit of ±15% of a target value; this limit was lowered to ±12% in 2008 and future reductions are as follows:

• 2009 Surveys: ±10%
• 2010 Surveys: ±8%
• 2011 Surveys: ±6% (“educational grade”)

When laboratories participate in CAP surveys they are comparing the results obtained on their system to this target value.

Since grading criteria is dropping by 2% each year, it will be more difficult for laboratories to pass their CAP survey if they are using an analyzer which gives them results outside of the acceptable grading limit.

Tosoh Provides High Precision with Low CVs

Precision is a measure of the consistency of results in the entire customer installed base, and this in turn affects how well the 6% limit will be achieved in 2011. With CVs of <2%, Tosoh leads the industry in HbA1c precision. The typical industry performance is 1.5-3.5% CVs(JCCLM 2007; 45: 1083-1097). According to Tosoh HPLC Product Manager Ranka Milojkovic, “The instrument-reagent system utilizes the gold standard ion-exchange method for HbA1c level testing to effectively monitor diabetes.”

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 the chromatogram. This represents the changes in absorbance versus retention time for each peak fraction. An analysis requires only 1.6 minutes.

TOSOH BIOSCIENCE