Indian Journal of Medical Biochemistry

Register      Login

VOLUME 25 , ISSUE 2 ( May-August, 2021 ) > List of Articles

Original Article

Perception of Measurement Uncertainty among Laboratorians and Clinicians in Indian Scenario

Kavyashree P Siddaramegowda, Anitha Devanath

Keywords : Measurement uncertainty, MU implementation, Perception of MU, Qualitative research, Serial result monitoring

Citation Information : Siddaramegowda KP, Devanath A. Perception of Measurement Uncertainty among Laboratorians and Clinicians in Indian Scenario. Indian J Med Biochem 2021; 25 (2):60-64.

DOI: 10.5005/jp-journals-10054-0180

License: CC BY-NC 4.0

Published Online: 29-10-2021

Copyright Statement:  Copyright © 2021; The Author(s).


Aim and objective: Measurement uncertainty (MU) calculation for quantitative parameters is a mandatory requirement as per ISO 15189:2012. The concept of MU and its applicability is still ambiguous although the terminology has been around for more than two-and-a-half decades. Since accreditation bodies are aligned to ISO 15189:2012, it is interesting to understand the extent of awareness of MU and perception of its usefulness in our clinical setting. Materials and methods: A questionnaire-based survey was conducted to understand the awareness and perception of MU along with interviews and focused group discussions. Prior training on how to use MU in a clinical setting was given before the survey. Responses to the questionnaire were analyzed using Microsoft Excel. Results: The majority of laboratorians were aware of the terminology and confident to explain the use of MU during test result-related queries. However, there were challenges anticipated such as complexity in calculating the ranges, incorporation in laboratory information system, and acceptability by patient population. Both laboratorians and clinicians felt that MU helps in analyzing patient results more accurately and this process of change would require more time for better acceptance. Conclusion: We conclude from our study that laboratory consultants with enough knowledge of MU can confidently introduce and implement MU in their daily practice. Clinicians were willing to interpret results with MU provided it was documented alongside the test report especially for the critical parameters which is obviously the challenging aspect for the labs. Clinical significance: The feasibility of the introduction of MU alongside patient's report is useful in interpreting critical parameters and provides a scientific evidence for consideration in a change of patient management rather than an arbitrary subjective analysis of serial monitoring of results.

  1. Working Group1 of the Joint Committee for Guides in Metrology. Evaluation of measurement data - guide to the expression of uncertainty in measurement. 1st ed. JCGM 2008;100, Available at: Accessed on 17th July 2020.
  2. Rifai N, Horvath AR, Wittwer C, ed. Tietz textbook of clinical chemistry and molecular diagnostics. St. Louis, Missouri: Elsevier; 2018. p. 1867.
  3. Clinical and Laboratory Standards Institute (CLSI). Expression of measurement uncertainty in laboratory medicine – Approved Guideline. CLSI document C51-A. Wayne, USA: CLSI; 2012.
  4. The Royal College of Pathologists of Australasia. Uncertainty of measurement. Guideline No. 2/2004. Available at: Accessed June 15th 2020.
  5. United Kingdom Accreditation Service. The expression of uncertainty and confidence in measurement traceability. M3003. 3rd ed., 2012. Available at: Accessed June 15th 2020.
  6. National Pathology Accreditation Advisory Council (NPAAC). Requirements for the estimation of measurement uncertainty. 2007 ed. Available at:$File/dhaeou.pdf. Accessed on 17th July 2020.
  7. American Association for Laboratory Accreditation. Policy on estimating measurement uncertainty for ISO 15189 testing laboratories. P903,2014. Available at Accessed 18th July 2020.
  8. Bell S, The beginner's guide to uncertainty of measurement. Available at: Accessed 10th June 2020.
  9. International Organization for Standardization (ISO), ISO 15189:2012 Medical Laboratories – Requirements for Quality and Competence. Geneva, Switzerland: International Organization for Standardization; 2012.
  10. Plebani M, Sciacovelli L, Bernardi D, et al. What information on measurement uncertainty should be communicated to clinicians, and how? Clin Biochem 2018;57:18–22. ISSN 0009-9120 10.1016/j.clinbiochem.2018.01.017.
  11. Plebani M. What information on quality specification should be communicated to clinicians, and how? Clin Chim Acta 2004;346(1):25–35. DOI: 10.1016/j.cccn.2004.03.019.
  12. Padoan A, Sciacovelli L, Aita A, et al. Measurement uncertainty in laboratory reports: a tool for improving the interpretation of test results. Clin Biochem 2018;57:41–47. DOI: 10.1016/j.clinbiochem.2018.03.009.
  13. Ayyildiz SN. The importance of measuring the uncertainty of second-generation total testosterone analysis. Int J Med Biochem 2018;1:34–39.
PDF Share
PDF Share

© Jaypee Brothers Medical Publishers (P) LTD.