In the Journals

HbA1c point-of-care test reliably diagnoses diabetes

A point-of-care HbA1c test using either finger stick or venous blood sampling can be used to accurately diagnose diabetes in adults, according to findings published in the Journal of Diabetes Science and Technology.

“Testing HbA1c at the [point of care] has the potential to decrease the fraction of undiagnosed diabetes because it can provide patient results within minutes and is well-suited for areas where medical laboratories may not be accessible,” Richard C. San George, PhD, of Abbott Rapid Diagnostics, a division of Abbott Laboratories in San Diego, and colleagues wrote. “However, the variable performance of some previous [point-of-care] devices in combination with a lack of mandatory proficiency testing in some [point-of-care] settings has led the [American Diabetes Association] to withhold its endorsement of [point-of-care] HbA1c methods for use in the diagnosis of diabetes.”

San George and colleagues assessed the Afinion HbA1c Dx test (Alere Technologies, subsidiary of Abbott Laboratories) by prospective and observational means using samples from 120 adults (mean age, 57 years; 56% women) across a range of HbA1c levels (4%-15%) that were taken by finger stick at three clinical sites in the U.S. Four groups were formed based on HbA1c levels and categorized as low (4%-5.99%), threshold (6%-6.99%), medium (7%-9.99%) and high (more than 10%). Venous blood samples were also taken from each participant, and three from each HbA1c group were analyzed using the point-of-care test.

The researchers found that using the point-of-care test with finger-stick and venous blood samples was “highly correlated” with the National Glycohemoglobin Standardization Program (NGSP) values (r = 0.99). They also noted “small bias results” when comparing point-of-care testing by finger-stick testing (mean differential bias, –0.021%) and venous blood samples (mean differential bias, –0.005%). In addition, 97.5% of results from the finger-stick point-of-care tests and 97.1% of the venous blood point-of-care tests fell within 6% of the reference method from the Diabetes Control and Complications Trial. At least 92.5% of results are currently required to fall within this range by the NGSP, although the program will adjust the requirements to be 90% within 5% of the reference result this year. The researchers noted that 95% of the finger-stick point-of-care test results and 93.3% of the venous blood POC test results fell within 5% of the reference in these new requirements.

“[Point-of-care] HbA1c testing has the potential to expand patient access to diabetes diagnostic testing and expedite medical decisions and interventions aimed at the prevention of diabetes and its complications, particularly for those who face challenges in accessing traditional health care settings or attending multiple laboratory and physician follow-up appointments,” the researchers wrote. – by Phil Neuffer

Disclosures: San George reports he is an employee of Abbott Laboratories, which funded this study. Please see the study for all other authors’ relevant financial disclosures.

A point-of-care HbA1c test using either finger stick or venous blood sampling can be used to accurately diagnose diabetes in adults, according to findings published in the Journal of Diabetes Science and Technology.

“Testing HbA1c at the [point of care] has the potential to decrease the fraction of undiagnosed diabetes because it can provide patient results within minutes and is well-suited for areas where medical laboratories may not be accessible,” Richard C. San George, PhD, of Abbott Rapid Diagnostics, a division of Abbott Laboratories in San Diego, and colleagues wrote. “However, the variable performance of some previous [point-of-care] devices in combination with a lack of mandatory proficiency testing in some [point-of-care] settings has led the [American Diabetes Association] to withhold its endorsement of [point-of-care] HbA1c methods for use in the diagnosis of diabetes.”

San George and colleagues assessed the Afinion HbA1c Dx test (Alere Technologies, subsidiary of Abbott Laboratories) by prospective and observational means using samples from 120 adults (mean age, 57 years; 56% women) across a range of HbA1c levels (4%-15%) that were taken by finger stick at three clinical sites in the U.S. Four groups were formed based on HbA1c levels and categorized as low (4%-5.99%), threshold (6%-6.99%), medium (7%-9.99%) and high (more than 10%). Venous blood samples were also taken from each participant, and three from each HbA1c group were analyzed using the point-of-care test.

The researchers found that using the point-of-care test with finger-stick and venous blood samples was “highly correlated” with the National Glycohemoglobin Standardization Program (NGSP) values (r = 0.99). They also noted “small bias results” when comparing point-of-care testing by finger-stick testing (mean differential bias, –0.021%) and venous blood samples (mean differential bias, –0.005%). In addition, 97.5% of results from the finger-stick point-of-care tests and 97.1% of the venous blood point-of-care tests fell within 6% of the reference method from the Diabetes Control and Complications Trial. At least 92.5% of results are currently required to fall within this range by the NGSP, although the program will adjust the requirements to be 90% within 5% of the reference result this year. The researchers noted that 95% of the finger-stick point-of-care test results and 93.3% of the venous blood POC test results fell within 5% of the reference in these new requirements.

“[Point-of-care] HbA1c testing has the potential to expand patient access to diabetes diagnostic testing and expedite medical decisions and interventions aimed at the prevention of diabetes and its complications, particularly for those who face challenges in accessing traditional health care settings or attending multiple laboratory and physician follow-up appointments,” the researchers wrote. – by Phil Neuffer

Disclosures: San George reports he is an employee of Abbott Laboratories, which funded this study. Please see the study for all other authors’ relevant financial disclosures.