Abstract

EVALUATION OF THE DIAGNOSTIC PERFORMANCE OF THE HEMOSPARK+ HEMOGLOBIN METER: A COMPARATIVE ANALYSIS AGAINST THE MINDRAY BC760 FULLY AUTOMATED HEMATOLOGY ANALYZER REFERENCE STANDARD

M. Bindu*, N Akshitha, Praveena

Abstract

Background: Given that Hemoglobin (Hb) is the vital respiratory protein responsible for oxygen transport and carbon dioxide removal, its accurate estimation remains a cornerstone of diagnostic blood analysis and anemia screening. While laboratory-based Automated Hematology Analyzers remain the gold standard, the increasing need for point-of-care testing by healthcare personnel necessitates the use of portable meters. This study evaluates the diagnostic accuracy and clinical reliability of the HemoSpark+ Hemoglobin meter in comparison to automated analyzers to determine its efficacy for both clinical and bedside monitoring. Objective: To evaluate the diagnostic accuracy of the HemoSpark+ Hemoglobin meter, hemoglobin levels were estimated in parallel with an Mindray BC760 Fully Automated hematology analyzer within a NABLaccredited laboratory environment. Materials and Methods: To determine the diagnostic correlation for anemia classification, hemoglobin levels were estimated simultaneously using the HemoSpark+ meter and an Mindray BC760 Fully Automated hematology analyzer. The study utilized 631 samples (565 adults and 66 pediatric cases) processed in a NABL-accredited facility between September 2025 and December 2025, ensuring sample integrity through standardized equipment-aided mixing protocols prior to analysis. Results: Comparative analysis confirmed the HemoSpark+ reliability against the Mindray BC760 Fully Automated hematology analyzer reference standard; The linear regression analysis shows an exceptional correlation between the two methods,the study recorded a strong r2 value of 0.985. The 95% LOA were narrow, ranging from -0.230 to +0.259 g/dL. It also has a negligible positive bias of +0.015 g/dL, indicating no systematic overestimation or underestimation by the HemoSpark+ meter. Conclusion: This study concludes that the HemoSpark+ digital hemoglobin meter demonstrates high analytical parity with the Mindray BC760 Fully Automated Hematology Analyzer reference standard. Given its strong statistical agreement and cost-efficiency relative to traditional hematology analyzers, the HemoSpark+ is highly suitable for point-of-care applications, particularly where rapid, isolated hemoglobin estimation is required.

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