Résumé
The aim was to evaluate the analytical performance of a point of care system, based on boron affinity chromatography, for recommended laboratory tests for monitoring of diabetes and lipids e.g. Hemoglobin A 1 c and lipid profile tests. The Afinion[TM] system [Afinion] is intended for use as POCT [Point Of Care Testing]. It is a fully automated boronate affinity assay. Ten samples for HbA1c, CRP and Lipids [Total Cholesterol, HDL-C, LDL-C and Triglycerides] were analyzed on the Afinion[TM] system and chemistry analyzer Cobas 6000 for comparison. Cobas 6000 is a fully automated chemistry analyzer from Roche Diagnostics. The analyzer uses NGSP traceable, immunoturbidimetry based method and lipids by standard photometric methods traceable to reference respective methods. Five samples were also tested in duplicate to check imprecision for each of the tests. The percentage bias for each of the tests was evaluated using Total Error Allowable [TEA] based on biological variation. The bias percentage was 1.643% for HbA1C, -2.764% for CRP, 1.439% for Total Cholesterol, -1.794% for HDL Cholesterol, 3.013% for LDL cholesterol, 3.473% for Triglycerides as compared to those on Cobas 6000. The strong correlations of HbA1c, CRP and Lipid profile performed on POCT with state of art automated chemistry analyzer indicate that the POCT can be used for monitoring of treatment at sites remote from the central laboratory with confidence. This can result in a faster turnaround time, prevent sample integrity issues as well as save transport costs. Accurate check of a new point of care system [Afinion TM AS 100 Analyzer, Axis-Shield PoC, AS, Oslo, N] prior to consideration for procurement was to evaluate usability of the device for a small physician-office type of laboratory