Assessment of the practicability and analytical performance of a point-of-care affinity chromatography haemoglobin A1c analyser for use in the non-laboratory setting.

摘要

BACKGROUND: Haemoglobin A(1c) (HbA(1c)) is a pivotal pathology test used around the world for the long-term management of patients with diabetes. Point-of-care testing (POCT) provides a convenient means for conducting HbA(1c) testing outside the laboratory. METHODS: The practicability and analytical performance of the Micromat II POCT HbA(1c) analyser (Bio-Rad Laboratories, USA), which has affinity chromatography as its methods principle, was evaluated in Australia and compared with the DCA 2000 POCT device (Bayer Australia) and a laboratory-based high-performance liquid chromatography (HPLC) method. RESULTS: Overall between-day imprecision over 10 days was 1.9% for the laboratory HPLC method, 2.2% for the DCA 2000 and 7.0% for the Micromat II. In a second study over the same time period, the Micromat II's imprecision was 6.4%. The mean difference between the Micromat II and the laboratory method in a patient comparison (n = 100) was -0.25% (lower and upper limits of agreement -1.79 to 1.30). CONCLUSIONS: The imprecision obtained with the Micromat II was inferior to both the DCA 2000 and laboratory methods and did not meet current internationally accepted precision goals for this analyte. The Micromat II's poor imprecision can be explained by the high degree of technical expertise needed to perform the test; its use by non-laboratory health professionals such as nurses and Aboriginal health workers in rural and remote Australia cannot be recommended.