Diagnosing Diabetes Mellitus: Performance of Hemoglobin A1c Point-of-Care Instruments in General Practice Offices

Abstract

BACKGROUND: Hemoglobin A 1c (Hb A 1c ) measurement by hospital laboratory instruments, but not by pointof-care (POC) instruments, has been recommended for use to diagnose diabetes mellitus. We evaluated results from 13 Hb A 1c external quality assurance (EQA) surveys over a 6-year period in Norway, from both POC instruments used in general practice (GP) offices and instruments in hospital laboratories, against the analytical quality specifications recommended for use of Hb A 1c to diagnose diabetes mellitus.

Three of 7 Hemoglobin A1c Point-of-Care Instruments Do Not Meet Generally Accepted Analytical Performance Criteria

“…In reviewing CAP survey results from recent years, it seems that not all POC instruments should be excluded for use in the diagnosis of diabetes because Afinion, DCA 2000, and DCA Vantage showed excellent results, even better than some laboratorybased methods (28 ). This was also the conclusion of an article recently published in clinical chemistry on the basis of the results of many years of an external quality scheme in Scandinavia (29 ). There are no barriers for the manufacturers of POC instruments to attempt to gain FDA approval to use their instrument for the diagnosis of diabetes.…”

Impact of HbA1c Testing at Point of Care on Diabetes Management

“…34 The remarkable improvement of analytical performance of POC devices for HbA1c testing in recent years, together with the development of new diagnostic materials 64 or the miniaturization of devices 48 argue in favor of an expansive diagnostic potential in the near future. 65 A further consideration for POC testing success is the implementation of appropriate quality control measures.…”

Overview of Diabetes Mellitus and its Treatment

“…[20] states that the diabetes are commonly diagnosed by conducting various tests such as A1C test, Fasting Plasma Glucose (FPG) test and Oral Glucose Tolerance Test. The A1C test is use to test the blood from the patient body and provides data about the level of sugar level in the body.…”