Validation of Hemochroma PLUS: A Point of Care Testing Device for Haemoglobin Estimation

Abstract

Introduction: Anaemia is a major public health challenge in India. Advent of Point of Care (POC) testing devices for haemoglobin estimation may be useful in the field settings, albeit after proper validation of these devices. Aim: To assess the validity of Hemochroma PLUS in haemoglobin estimation by comparing it with an automated laboratory analyser in rural Indian context. Materials and Methods: A cross-sectional study was conducted at a tertiary care rural teaching hospital during NovemberDecember 2017. Adults visiting the out-patient laboratory collection unit for a haemogram test were included in the study. Venous blood samples were collected by trained phlebotomists and tested using autoanalyser in the laboratory. Capillary blood samples were collected by a trained study coordinator using a lancet (Ez-life) and tested on a Hemochroma PLUS device. Haemoglobin measurement by both methods was compared using Bland-Altman analysis. The analysis was performed using STATA (14.2). Results: A total of 100 (53 females and 47 males) adults participated in the study. Mean (SD) age of the participants was 44.62 (16.92) years. Bland-Altman analysis revealed that the mean difference (95% confidence limits) was 0.3 (-2.0, 2.7) gm/dL. Hemochroma PLUS was found to have sensitivity of 84.90% and specificity of 82.98% in identifying anaemia. Conclusion: Hemochroma PLUS showed good agreement with the cell counter in current study. Further studies may be undertaken in different study populations and study settings. Hemochroma PLUS, has a potential as a POC tool for community-based anaemia screening and evaluation of anaemia control programmes.

Keywords

• anaemia
• bedside testing
• cell counter
• method comparison