Analytical Goals for Point-of-Care Testing Used for Diabetes Management in Australian Health Care Settings Outside The Laboratory

Diabetes mellitus is a major global health problem. Pathology testing for hemoglobin A1c (HbA1c), lipids, and urine albumin/creatinine ratio (ACR) has an important role in the management of diabetes patients. Each of these markers can be performed by point-of-care testing (POCT). This article focuses on setting analytical goals (quality specifications) for the imprecision, bias, and total allowable error of these selected POC tests in the public health environment in Australia. The article reviews published data on analytical goal setting for laboratory tests, considers the factors that set POCT apart from the laboratory, compares laboratory-based analytical goals with state-of-the-art performance, and then sets analytical goals that are designed to be relevant for nonlaboratory POCT environment. The desirable analytical goals for imprecision are the following: HbA1c, 3%; cholesterol, 3%; triglyceride, 5%; high-density lipoprotein cholesterol, 4%; low-density lipoprotein cholesterol, 4%; urine albumin, 10%; urine creatinine, 6%; and urine ACR, 12%. The analytical goals for total allowable error are the following: HbA1c, 4%; cholesterol, 10%; triglyceride, 15%; high-density lipoprotein cholesterol, 15%; low-density lipoprotein cholesterol, 15%; urine albumin, 12.5%; urine creatinine, 7.5%; and urine ACR, 15%. The recommended analytical goals are designed to be flexible and refinable as more data, particularly from clinical outcome studies, become available. They have the potential to be adopted by countries outside Australia, given the limited published data on analytical goals specifically for the nonlaboratory POCT sector.