Assessment of the Konsung hemoglobin analyzer’s accuracy and precision compared to the standard method in measuring hemoglobin and hematocrit levels

Abstract

            Background: The measurement of hemoglobin (Hb) and hematocrit (Hct) is essential for the diagnosis and monitoring of anemia. Automated hematology analyzers and the microhematocrit centrifuge are considered standard methods. However, point-of-care testing (POCT) devices such as the Konsung hemoglobin analyzer have gained increasing interest due to their convenience and rapid turnaround time. This study aimed to evaluate the accuracy and precision of the Konsung hemoglobin analyzer compared with standard methods.

                   Methods: This quasi-experimental analytical study included 100 patient blood samples, classified into three groups based on hemoglobin levels: low (male < 13.0 g/dL, female < 12.0 g/dL; n = 46), normal (male 13.0–16.5 g/dL, female 12.0–15.0 g/dL; n = 34), and high (male > 16.5 g/dL, female > 15.0 g/dL; n = 20). Hemoglobin and hematocrit levels were measured using the Konsung hemoglobin analyzer and compared with the Sysmex XN-3000 and the microhematocrit centrifuge within 2 hours after sample collection. Correlation analysis was performed using Pearson’s correlation coefficient. Agreement was evaluated using Bland–Altman analysis, including bias and limits of agreement (LoA). Precision was assessed using the coefficient of variation (%CV).

                   Results: Hematocrit values showed a strong correlation with the standard method (r = 0.975, p < 0.001), while hemoglobin values demonstrated a very strong correlation (r = 0.985, p < 0.001). Hematocrit showed a slight positive bias compared with the microhematocrit centrifuge method (+0.36%) and the Sysmex XN-3000 (+0.19%). The limits of agreement (LoA) for hematocrit ranged from -3.26% to +3.98% compared with the microhematocrit centrifuge method, and from -3.44% to +3.82% compared with the XN-3000. Hemoglobin measurements showed a positive bias of +0.49 g/dL compared with the XN-3000, with LoA ranging from -0.49 to +1.47 g/dL, all within clinically acceptable limits. Precision analysis demonstrated %CV values of less than 7% at all levels.

                   Conclusion: The Konsung hemoglobin analyzer demonstrated acceptable accuracy and precision compared with standard methods and can be used as a point-of-care testing device to support rapid clinical assessment. However, confirmatory testing using standard methods should be considered in cases with significant clinical implications.