Validation Study of the Tamiacs Digital Hemoglobinometer

Abstract

Background: Accurate hemoglobin estimation is central to the detection and classification of anemia. Point-of-care digital hemoglobinometers can facilitate rapid testing in outpatient, community and resource-constrained settings. This study evaluated the analytical precision and diagnostic agreement of the Tamiacs Digital Hemoglobinometer at the C.R PARIKH BLOOD CENTER, KAPADWANJ. Methods: A cross-sectional validation study was conducted among 100 participants aged 15–74 years. Women constituted 53% of the study population and men 47%. Hemoglobin measurements obtained with the Tamiacs Digital Hemoglobinometer were compared with a designated reference method using Sysmex XP 300. Diagnostic performance was assessed using sensitivity and specificity. Analytical precision was summarized using coefficient of variation (CV), and agreement between methods was assessed using Bland–Altman analysis. Results: The reported sensitivity was 98.3% and specificity was 98.1%. The coefficient of variation was reported as less than 3%. Bland–Altman analysis demonstrated 95% limits of agreement from -0.3 to +0.5 g/dL. The mean bias, calculated as the midpoint of the reported limits of agreement, was +0.10 g/dL. The corresponding estimated standard deviation of paired differences is approximately 0.20 g/dL. Conclusion: In this study population, the Tamiacs Digital Hemoglobinometer demonstrated high reported sensitivity and specificity, low analytical variability, and close agreement with the reference method.