Performance analysis of point-of-care testing haemoglobin concentration methods with automated haematology analyser amongst blood donors

Abstract

Background: In terms of rapidness, testing methodology and sensitivity, point-of-care (POC) testing devices provide quality in haemoglobin (Hb) check for safe donation of blood. Methods: This was a prospective observational study in a tertiary care centre. Capillary finger-prick samples obtained from 100 blood donors were analysed prior to donation using reagent-free cuvettes (DiaSpect Tm), digital haemoglobinometer (True Hb) and Hb photometer (HemoCue 301). Venous samples were drawn for analysis on haematology analyser. Donors were accepted based on copper sulphate method acceptance criteria. The performance of the devices was evaluated considering automated haematology analyser (Sysmex XN 1000) as the gold standard. Results: The mean Hb value using Sysmex XN 1000, HemoCue 301, DiaSpect Tm and True Hb were 14.8 ± 1.1 g/dL, 15.4 ± 1.8 g/dL, 15.3 ± 1.8 g/dL and 18.6 ± 2.8 g/dL, respectively. The sensitivity of True Hb, DiaSpect Tm, HemoCue 301 and copper sulphate method were 96.8%, 96.8%, 3.7% and 98.9%, respectively. DiaSpect Tm had a specificity of 60% whereas specificity of True Hb and copper sulphate method were 20% each. True Hb, HemoCue 301, DiaSpect Tm and copper sulphate had a positive predictive value of 95.8%, 94.7%, 97.9% and 95.9% and accuracy of 93%, 89%, 95% and 95%, respectively. The mean turnaround time was 1 sec for DiaSpect Tm whereas 35.3 sec and 2.6 sec for True Hb and HemoCue 301, respectively. The copper sulphate test provided the highest rate of donor’s acceptance, despite unacceptable Hb levels. Conclusions: DiaSpect Tm has the advantage of rapid turnaround time, high specificity and accuracy when compared to gold standard method.

Keywords

• blood donors
• haemoglobin concentration methods
• performance analysis