Performance Evaluation and Validation of Neodocs Hb Testing Point-Of-Care Device with Standard Laboratory Analyzer

Accurate Hb measurement is crucial for diagnosing and managing anemia. In India, anemia represents a significant public health crisis, affecting over 40% of the population and necessitating comprehensive interventions to address its widespread impact. In April 2018, the Indian Ministry of Health and Family Welfare launched the Anemia Mukt Bharat (AMB) strategy as a comprehensive national initiative to address and significantly reduce the substantial and pervasive public health issue of anemia within the country. Pointof-care testing (POCT) of anemia using digital hemoglobinometers and treatment is one of the primary interventions under AMB. To improve clinical decision-making and enable large-scale screening initiatives, our organization designed an innovative point-of-care Hb testing device that provides quick, accurate results. The analytical performance was assessed through a validation study performed at the Dr. Jariwala Laboratory, a NABL-accredited facility, ensuring the reliability and accuracy of the results. A total 3 batches with 30 samples provided capillary blood samples which underwent simultaneous analysis using the Neodocs (ND)-Hb device and a standard laboratory haematology analyzer (Mindray BC-780 Haematology System) to ensure accurate and comparable results. The device exhibited high precision and minimal variability across different hemoglobin ranges, demonstrating strength in detecting moderate-to-severe anemia. No significant operational errors or user-related issues were reported during the study, highlighting the device's usability in point-of-caresettings.Further, the results were reproducible with maximum standard deviation 0.57, suitable for use on regular patient's sample.