Evaluation of the utility of the HemoCue 301 haemoglobinometer for blood donor screening

Abstract

Reliable blood donor screening requires more accurate measure of haemoglobin (Hb) than by either copper sulphate or the haemoglobin colour scale. The HemoCue haemoglobinometer has established a method for this, but it is considerably more expensive; a modified version (HemoCue 301) has now been developed with a cheaper reagent-free cuvette for use in budget-restricted situations. This report describes evaluation of the performance, the assessment of reproducibility and accuracy of this modified analyser against the reference technique for Hb measurement. Over 300 routine blood samples from specimens received routinely in a hospital laboratory were tested in accordance with the International Committee for Standardization in Haematology (ICSH) protocol. Accuracy and linearity were confirmed by the reference method with the WHO international haemoglobincyanide reference standard. Tests were also performed on selected samples for checking interference by biochemical abnormalities and leucocytosis. The effects of various sample storage conditions prior to testing were also tested. Ninety per cent of results were within 4% of true values, 96% within 6% and in only three cases was the deviation > 10%, due to interference by bilirubinaemia and/or C-reactive protein. At an Hb value of 120 g/l for donor selection, there were no cases where the method would have been misleading. HemoCue 301 provides a simple and reliable anaemia screen method, conforming to the requirements of CLIA'88 regulations; it is reliable for discriminating Hb values for donor acceptance. The main advantage is that the cuvettes are significantly cheaper than the previous models, and will not deteriorate in adverse climatic conditions.