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

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

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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 here 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 7-OH 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.