Comparison of four methods to measure haemoglobin concentrations in whole blood donors (COMPARE): a diagnostic accuracy study

Objective: To compare four haemoglobin measurement methods in whole blood donors. Background: To safeguard donors, blood services measure haemoglobin concentration in advance of each donation. NHS Blood and Transplant9s (NHSBT) usual method has been capillary gravimetry (copper sulphate), followed by venous HemoCue (spectrophotometry) for donors failing gravimetry. However, gravimetry/venous HemoCue results in 10% of donors being inappropriately bled (i.e., with haemoglobin values below the regulatory threshold). Methods: The following were compared in 21,840 blood donors (aged >=18 years) recruited from 10 mobile centres of NHSBT in England, with each method compared with the Sysmex XN-2000 haematology analyser, the reference standard: 1) gravimetry/venous HemoCue; 2) post donation approach, i.e., estimating current haemoglobin concentration from that measured by a haematology analyser at a donor9s most recent prior donation; 3) capillary HemoCue; and 4) non-invasive spectrometry (MBR Haemospect or Orsense NMB200). We assessed each method for sensitivity; specificity; proportion of donors who would have been inappropriately bled, or rejected from donation (ie, deferred) incorrectly; and test preference. Results: Compared with the reference standard, the methods ranged in test sensitivity from 17.0% (MBR Haemospect) to 79.0% (HemoCue) in men, and from 19.0% (MBR Haemospect) to 82.8% (HemoCue) in women. For specificity, the methods ranged from 87.2% (MBR Haemospect) to 99.9% (gravimetry/venous HemoCue) in men, and from 74.1% (Orsense NMB200) to 99.8% (gravimetry/venous HemoCue) in women. The proportion of donors who would have been inappropriately bled ranged from 2.2% in men for HemoCue to 18.9% in women for MBR Haemospect. The proportion of donors who would have been deferred incorrectly with haemoglobin concentration above the minimum threshold ranged from 0.1% in men for gravimetry/venous HemoCue to 20.3% in women for OrSense. Most donors preferred non-invasive spectrometry. Conclusion: In the largest study reporting head-to-head comparisons of four methods to measure haemoglobin prior to blood donation, our results support replacement of venous HemoCue with the capillary HemoCue when donors fail gravimetry. These results have had direct translational implications for NHS Blood and Transplant in England.