Introduction: The aim of this study was to evaluate the performance of the newly developed handheld hemoglobinmeter (TrueHb) by comparing its performance against and an automated five-part hematology analyzer, Sysmex counter XT 1800i (Sysmex).
Methods: Two hundred venous blood samples were subjected through their total hemoglobin evaluation on each device three times. The average of the three readings on each device was considered as their respective device values, that is, TrueHb values and Sysmex values. The two set of values were comparatively analyzed. The repeatability of the performance of TrueHb was also evaluated against Sysmex values.
Results: The scatter plot of TrueHb values and Sysmex values showed linear distribution with positive correlations (r = 0.99). The intraclass correlation (ICC) values between the two set of values was found to be 0.995. Regression coefficients through origin, β, was found to be 0.995, with 95% confidence intervals (CI) ranging between 0.9900 and 1.0000. The mean difference in Bland-Altman plots of TrueHb values against the Sysmex values was found to be -0.02, with limits of agreement between -0.777 and 0.732 g/dL. Statistical analysis suggested good repeatability in results of TrueHb, having a low mean CV of 2.22, against 4.44, that of Sysmex values, and 95% confidence interval of 1.99-2.44, against 3.85-5.03, that of Sysmex values.
Conclusion: These results suggested a strong positive correlation between the two measurements devices. It is thus concluded that TrueHb is a good point-of-care testing tool for estimating hemoglobin.
Keywords: Sysmex; TrueHb; hemoglobin; hemometer; performance validation.
© 2014 John Wiley & Sons Ltd.