Performance Evaluation of Point of Care Hemoglobinometers

Abstract

Nowadays, several point of care hemoglobinometers exist in the market. These devices have significant advantages such as an ability to take rapid non-invasive measurements and the ease of use. The Hb 201 DM Analyzer and the Hemo Control Manager are amongst such devices that come equipped with data management functions and provide convenience through a quality control system, barcode reader for patient identification, and ability to transfer patient results to a hospital’s information system. The aim of this work was to compare their performance. A precision study was conducted according to a standard clinical and laboratory guideline. The linearity of each device was assessed by measuring five concentrations of hemoglobin in blood samples. To ensure accuracy of the study, forty leftover venous blood samples were measured by the two point of care hemoglobinometers. The average result of each sample was compared against our routine analyzer, the Sysmex XN-3000. Both the Hb 201 DM Analyzer and the Hemo Control Manager had a CV of less than 2% and the measuring ranges were 0.8 - 21.4 g/dL and

1.0 to 22.2 g/dL, respectively. Bland-Altman plots of the Hb 201 DM Analyzer and the Hemo Control Manager compared against the Sysmex XN-3000 showed almost no difference. Moreover, the intraclass correlation coefficients displayed an almost perfect agreement (1.000 for the Hb 201 DM Analyzer and 0.999 for the Hemo Control Manager). Both the Hb 201 DM Analyzer and the Hemo Control Manager devices have good precision, acceptable measuring range, and reliable correlation with automated hematology analyzers.