Laboratory evaluation of the DCA 2000 clinic HbA1c immunoassay analyser

The DCA 2000 clinical analyser for the measurement of haemoglobin A1c was evaluated for analytical quality. The analyser, which utilises inhibition of latex agglutination immunoassay, demonstrated good within-batch (1.9-3.1% CV) and between-batch (2.2% CV) imprecision, and was not affected by haemoglobin concentration. The analyser was linear throughout the analytical range, and was found to correlate well with agar electroendosmosis (r = 0.93), affinity chromatography (r = 0.97), HPLC (r = 0.90) and EIA (r = 0.98). The analyser was found to give reliable analytical results, and with its ease of use, will provide the diabetologist with HbA1c results in the clinic; although an analysis time of 9 min will limit sample throughput.