The aim of this study was to evaluate the performance of the portable Hemoglobinometer “HbChek” by comparing its performance against automated Three-part hematology analyzer, Medonic M20. Total 731 venous blood samples were subjected through their total hemoglobin evaluation. Each sample was run only once on reference device and HbChek. The two set of values were comparatively analyzed. The repeatability of the performance of HbChek was also evaluated against Medonic M20 values. The scatter plot of HbChek values and Medonic M20 values showed linear distribution with regression correlations r=0.99. The intraclass correlation (ICC) between the two set of values was found to be 0.9952 with 95% confidence intervals (CI) ranging between 0.9945 and 0.9959. The mean difference in Bland–Altman plots of HbChek values against the Medonic M20 values was found to be -0.08 g/dL, with limits of agreement between 0.60 g/dL and -0.75 g/dL. Coefficient of Variation was found to be 2.8% (SD/Mean=0.35/12.4). Sensitivity & Specificity was found at 93.2 % & 98.6% respectively. These results suggest a strong positive correlation with laboratory machines differences less than 0.8 g/dL. In addition, high sensitivity &high specificity value with easiness of use can make HbChek appropriate technology for public health systems like Sub-Centers & PHCs.
Keywords: Hemoglobinometer, Coefficient of Variation, Sensitivity & Specificity
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