Multiple-Site Analytic Evaluation of a New Portable Analyzer, HemoCue Hb 201+, for Point-of-Care Testing

Abstract

The analytic performance of the HemoCue Hb 201+ system was validated to major automatic cell counters in the marketplace and to the previous HemoCue B-Hemoglobin system. In addition, the performance of all instruments was compared against the ICSH reference method. Between 119 and 138 samples were analyzed at 4 different hospitals. In all, 497 patient samples were tested. Imprecision calculated from duplicate samples for all systems ranged from 0.5 to 1.1%. The correlation for all systems against the reference method was better than 0.99 overall, with biases ranging from –0.28 to 0.21 g/dL. Correlations between the new Hb 201+ and ADVIA 120 (Bayer Diagnostics), GEN-S (Beckman Coulter), Sysmex XE 2100, CellDyn 4000 (Abbott), and the HemoCue B-Hemoglobin system showed all r > 0.99. The HemoCue Hb 201+ had a mean bias of 0.10 g/dL from the reference method and between –0.06 to 0.43 g/dL against the other instruments. Imprecision calculated from duplicate samples on the HemoCue Hb 201+ system was 0.75%. The authors conclude that all hemoglobin methods tested including the new HemoCue Hb 201+ system showed excellent correlation and very small bias to the international reference method. The Hb 201+ system yields results that agreed well with all tested systems, with an accuracy and precision similar to the cell counters.