Digital Hemoglobinometers as Point-of-Care Testing Devices for Hemoglobin Estimation: A Validation Study from India

INTRODUCTION: India has launched Anemia Mukt Bharat (AMB) strategy in 2018, to deal with the high burden of anemia in the country. Point-of-care testing (POCT) of anemia using digital hemoglobinometers and treatment is one of the primary interventions under AMB. This study aimed to determine the diagnostic validity of digital hemoglobinometers (TrueHb and HemoCue 301) for screening of anemia compared to hematology analyzer. METHODOLOGY: A hospital-based, cross-sectional study was conducted among pregnant women attending antenatal clinics of a selected primary health center and subdivisional hospital of Haryana, India, during January 2019. Hemoglobin (Hb) levels of the pregnant women were estimated in digital hemoglobinometers using capillary blood samples and hematology analyzer using venous blood samples. Bias, limits of agreement (LOA), and validity of digital hemoglobinometers were assessed against a hematology analyzer. RESULTS: A total of 110 pregnant women were included. Bias (LOA) in Hb values estimated using digital hemoglobinometers was −0.09 g/dL (−1.97 to 1.80 ) for HemoCue301 and −0.04 g/dL (−1.69 to 1.60) for TrueHb compared to the hematology analyzer. HemoCue(®) 301 (sensitivity: 86% and specificity: 83%) had relatively higher sensitivity and specificity compared to TrueHb (sensitivity: 78.9% and specificity: 81%). CONCLUSIONS: Digital hemoglobinometers have high sensitivity and specificity. Thus, these can be a potential POCTs for screening of anemia in peripheral health facilities. Further studies are required to establish the validity of the digital hemoglobinometers at community settings.