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

Abstract

SUMMARYObjectiveTo compare four haemoglobin measurement methods in whole blood donors.BackgroundTo safeguard donors, blood services measure haemoglobin concentration in advance of each donation. NHS Blood and Transplant’s (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).MethodsThe 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 donor’s 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 (“deferred”) incorrectly; and test preference.ResultsCompared 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.ConclusionIn 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.

SARS-CoV-2 responsive T cell numbers and anti-Spike IgG levels are both associated with protection from COVID-19: A prospective cohort study in keyworkers

“…We also measured total anti-Nucleoprotein antibody (Roche Elecsys), considering positive assays with index >1.0, which is the manufacturer’s recommended cut-off, as a secondary assay. To assess background levels in these assays, we analysed pre-pandemic plasma from the COMPARE study (36) using the same assays.…”

Accuracy of four lateral flow immunoassays for anti SARS-CoV-2 antibodies: a head-to-head comparative study

“…We analysed blood samples from 2,847 key workers participating in the EDSAB-HOME study and 1,995 pre-pandemic blood donors from the COMPARE study [27], in a laboratory setting. All samples were from distinct individuals.…”

“…Of the known positives reporting symptoms, the median (interquartile range) number of days between symptom onset and study clinic was 63 (52 to 75). COMPARE (ISRCTN90871183) was a 2016-2017 blood donor cohort study in England [27]. We performed stratified random sampling by age, sex and region to select 2,000 participants, of whom 1,995 had samples available for analysis.…”

Accuracy of four lateral flow immunoassays for anti SARS-CoV-2 antibodies: a head-to-head comparative study

“…We analysed blood samples from 2,847 key workers participating in the EDSAB-HOME study and 1,995 pre-pandemic blood donors from the COMPARE study (24), in a laboratory setting. All samples were from distinct individuals.…”

“…COMPARE (ISRCTN90871183) was a 2016-2017 blood donor cohort study in England (24). We performed stratified random sampling, by age, sex and region to select 2,000 participants, of whom 1,995 had samples available for analysis.…”