DIABETES: A Worldwide Epidemic
Article By Shannon Rose

Read full article at http://www.clpmag.com/issues/articles/2010-01_01.asp

As all forms of diabetes continue to increase in incidence, testing options also expand.

Approximately 23.6 million children and adults in the United States—almost 8% of the population—suffer from diabetes, according to the 2007 National Diabetes Fact Sheet.

Of these, approximately 5.7 million go undiagnosed, and 57 million people are estimated to be prediabetic. In addition, 1.6 million new cases are diagnosed every year in individuals 20 years and older, according to the fact sheet compiled by the Centers for Disease Control (CDC), National Institutes of Health (NIH), and the American Diabetes Association (ADA), among others. The World Health Organization (WHO) estimates that approximately 300 million individuals worldwide will be living with diabetes by the year 2025.

In all three forms of the metabolic disorder—type 1 and 2 diabetes, and gestational diabetes—the body is unable to effectively control its glucose levels. More than 90% of diabetics suffer from type 2 diabetes, in which either the pancreas does not produce enough insulin, or the body does not utilize the insulin it has to effectively control glucose levels. In individuals with type 1 diabetes, the body attacks the pancreas to such a degree that it does not produce insulin at all.

The high prevalence of the condition and its complications make diabetes a significant public health issue. The consequences caused by uncontrolled blood sugar in persons with diabetes are severe, and they include heart disease and stroke, high blood pressure, blindness, diseases of the nervous system, amputations, and dental disease.

According to the fact sheet, costs of the disease in the United States are estimated at $218 billion, including $18 billion for those with undiagnosed diabetes and $623 each for the 180,000 pregnant women with gestational diabetes. In 2006, the condition was the seventh leading cause of death in the nation.

“It’s not that diabetes is difficult to diagnose,” says Randy Byrd, vice president and chief technical officer at Bionostics Inc, Devens, Mass. “The problem is that many people are undiagnosed. The challenge for labs is the ability to access patients to perform the testing which provides diagnosis.”

Changing the Gold Standard

Until recently, the gold standard for diagnosis of diabetes was the measurement of glucose levels, with increased glucose concentration in urine or blood indicating diabetes.

The two main tests are the direct measurement of glucose levels in the blood during an overnight fast—the fasting plasma glucose test (FPG)—and a test that measures blood glucose levels four to five times over a 3-hour period—the oral glucose tolerance test (OGTT). While the WHO advocates the OGTT, the ADA advocates the FPG.

However, at the ADA’s annual meeting in June, a committee of international experts recommended the A1C assay test as a new diagnostic tool, except for gestational diabetes. The A1C test, also known as glycated hemoglobin or HbA1c, is a blood test that measures a person’s average blood glucose control over the preceding 2 to 3 months. The excess glucose produced by diabetics glycates with—or sticks to—hemoglobin, which carries oxygen from the lungs to the body’s cells.

The A1C test measures the percentage of this glycated hemoglobin in the blood, which is a reflection of average blood glucose control. The test is not new, but has been used for the past 30 years to determine how well a patient controls diabetes, rather than as a diagnostic tool.

The report could instigate a change in the way diabetes is diagnosed, the ADA said. The international committee concluded that an A1C level of 6.5% indicates that a person has diabetes, while values between 6% and 6.5% are likely to be at highest risk for developing diabetes.

“The A1C test is a more stable, reliable diagnostic tool than the OGTT or the FPG,” says Ranka Milojkovic, HPLC product manager at Tosoh Bioscience Inc, San Francisco. “There are problems with reproducibility and accuracy with the tests that measure glucose.”

Advances in Instrumentation—the Next Generation

According to Milojkovic, lack of standardization kept the A1C test from being recommended as a diagnostic tool. Advances in instrumentation and standardization have eliminated the major roadblocks to the use of the test for diagnosis. Currently, it is mainly performed in hospital and reference laboratories, using either high-performance liquid chromatography (HPLC), often considered the gold standard, or immunoassay methods.

Launched in December 2008, Tosoh’s G8 HPLC Analyzer is the next generation of Tosoh’s industry-leading HPLC testing systems. Designed from a user perspective and using ion-exchange technology, the G8 HPLC Analyzer enhances overall safety and convenience of operation.

The system, which is certified by the National Glycohemoglobin Standardization Program, features stable A1C results in 1.6 minutes through in vitro diagnostic measurement of HbA1c in blood specimens. It has a compact footprint of 21 x 20 x 19 inches and automated daily maintenance.

“We are always thinking of our customer,” Milojkovic says. “Labs are under pressure as there is greater demand to run more samples in less time, and we wanted to address that and design a high-speed analyzer with high resolution. There is no faster HbA1c assay out there.”

Forty flags, or machine parameters, allow the system to print out only those results that the user needs to analyze.

“This reduces review time for patient results,” Milojkovic says.

The throughput for 50 tests takes 1 hour and 20 minutes, while 100 tests can be performed in 2 hours and 40 minutes. There are two loaders available: the standard 90-sample loader, which has a walkaway time of 2 hours and 24 minutes, and the 290-sample loader, which has a walkaway time of 7 hours and 44 minutes (basically one shift for a lab technician).

“The technician can load it in the morning and leave it for the whole day,” Milojkovic says.

To continue reading, see complete article by Shannon Rose at http://www.clpmag.com/issues/articles/2010-01_01.asp

“DIABETES: A Worldwide Epidemic” CLP Article Discusses Tosoh G8 HPLC Analyzer

What is diabetes?

Diabetes is a disease in which the body is unable to produce or unable to properly use and store glucose (a form of sugar). Glucose accumulates in the bloodstream — causing one’s blood glucose or “sugar” to rise too high. 



There are two major types of diabetes.  In type 1 (also called juvenile-onset or insulin-dependent) diabetes, the body completely stops producing any insulin, a hormone that enables the body to use glucose found in foods for energy. People with type 1 diabetes must take daily insulin injections to survive. This form of diabetes usually develops in children or young adults, but can occur at any age.

Type 2 (also called adult-onset or non insulin-dependent) diabetes results when the body doesn’t produce enough insulin and/or is unable to use insulin properly (insulin resistance). This form of diabetes usually occurs in people who are over 40, overweight, and have a family history of diabetes, although it is increasingly occurring in younger people, particularly adolescents. One in three or 58 million American adults aged 20 through 74 are overweight. According to data from the Third National Health and Nutrition Examination Survey (NHANES III), the number of overweight Americans increased from 25 to 33 percent between 1980 and 1991.

HbA1c Testing News: Team Tosoh for Diabetes Awareness

Tosoh and Diabetes

Tosoh provides diagnostic systems that are used in managing diabetes.  Tosoh HPLC systems are fully automated and rapidly separate hemoglobins found naturally in human blood.  One of the components of red blood cells is hemoglobin. Glucose, combines with hemoglobin to form the ‘glycated hemoglobin’ molecule, called hemoglobin A1c or HbA1c.  The more glucose in the blood, the more hemoglobin A1c or HbA1c will be present in the blood.  Red cells live for 8 -12 weeks before they are replaced.  By measuring the HbA1c a person will know how well their blood glucose has been controlled over the last 8-12 weeks.  A normal, non-diabetic HbA1c is 3.5-5.5%. With type 2 diabetes 6.5% is a good target.

The HbA1c test is currently one of the best ways to monitor diabetic control.

For more information about Tosoh HbA1c Testing for diabetes monitoring, go to Tosoh G8 HPLC Analyzer.

Tosoh G8 HPLC Analyzer

Tosoh Manufactures Products for HbA1c Testing

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