An assessment of standardisation of HbA1c testing across clinical laboratories in India and its impact on diabetes management.

Objectives: This study is aimed at evaluating the degree of standardisation of HbA1c and glucose testing across accredited laboratories in India.

Methods: The information declared on the scope of testing by 147 medical laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) across India was used by the authors for this study (http://www.nabl-india.org). This information on the scope of testing is available within the public domain and is accessible through the NABL website and covered laboratories accredited between 2009 and 2012. We focussed on HbA1c and glucose tests offered by laboratories and documented the way tests were named, the methodologies used and the degree of confidence in testing based on the coefficient of variation (CV). The data was independently reviewed by two medical biochemists and then subjected to analysis.

Results: Although the glucose test appeared to be ubiquitous, HbA1c assays appeared on the scope of testing in 87.1% of the laboratories. The HbA1c tests however appear to be poorly standardised across laboratories. We noted gross differences in test nomenclature, methodology and analytical performance across laboratories.

Conclusion: This is one of the first studies that has focussed on the standards of laboratory care for diabetes management in India. The study highlights the lack of standardisation in nomenclature, analytical performance and methodology of tests used for HbA1c in NABL accredited laboratories across India. Affirmative actions in terms of improved regulation, patient advocacy, further studies on impact of laboratory quality and education of physicians, healthcare providers, laboratorians may improve harmonisation and quality of patient care in diabetes in India.