Comparative Performance Analysis of a Digital Hemoglobin Meter (HBSPOT) Against Standard Laboratory Method in a Real-World Setting

Background: Timely and accurate hemoglobin measurement is essential for anemia diagnosis, especially inoutreach and rural healthcare settings. Digital POC devices may serve as effective alternatives to laboratory-basedmethods.Aim and Objectives: To evaluate the diagnostic utility and agreement of the HB SPOT digital hemoglobin meterwith the standard cyanmethemoglobin method at Site B.Materials and Methods: This prospective diagnostic accuracy study was conducted from March 2024 toSeptember 2024 at Department of Medicine, DY Patil Medical College and Research Centre, Pune. A total of 250adults participants ≥18 years from inpatient and outpatient settings underwent hemoglobin testing via the HBSPOT device and the reference method. Statistical analyses included Pearson’s correlation, Bland-Altman plot,ROC curve, and calculation of sensitivity and specificity.Results: The HB SPOT yielded a mean hemoglobin of 12.04 ± 2.51 g/dL, while the reference method reported12.16 ± 2.43 g/dL. Pearson’s correlation coefficient was 0.951. The Bland-Altman analysis indicated a mean biasof -0.14 g/dL (limits: -1.55 to +1.27 g/dL). Sensitivity and specificity were 91.8% and 90.2%, respectively. TheROC curve had an AUC of 0.957 (95% CI: 0.932–0.979), confirming high diagnostic accuracy.Conclusion: The HB SPOT device closely aligns with standard hemoglobin measurement, offering rapid, reliableresults. Due to its ease of use and strong diagnostic metrics, it is well-suited for screening in decentralized healthenvironments.