Clinical laboratory · 2026
Standardized Estimation of Measurement Uncertainty in Clinical Chemistry Using ISO 20914.
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Ahmad Mohammad I, Ahmed Fayha S, Rao Deepa, Begum Mohamedi, Joan Shiefa
Аннотация
BACKGROUND: The degree to which one is certain of results for a particular measurement/testing process is expressed as a confidence level within a range. Measurement uncertainty (MU) is a critical parameter in clinical chemistry, reflecting the degree of confidence in laboratory test results and directly influencing diagnostic accuracy and patient care.
METHODS: The study calculated MU for 27 general chemistry analytes using the ISO 20914:2019 top-down approach, which uses long-term internal quality control (IQC) data and manufacturer calibrator traceability certificate values. The study was conducted at Nad al Hammar Health Center, Dubai Health, Dubai, using Roche Cobas Pure analyzers. The study compared calculated MU values with maximum allowable uncertainty (MAU) thresh-olds obtained from the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) biological variation database.
RESULTS: The results show that 17 analytes met the desirable MAU criteria at IQC level 1, confirming robust analytical performance. However, 10 analytes - including albumin, alkaline phosphatase, calcium, magnesium, phosphorus, transferrin, troponin T hs, uric acid, urine albumin, and vitamin D - exceeded the desirable MAU limits, suggesting potential areas for method optimization or high signal to noise ratio at quality control level 1.
CONCLUSIONS: The findings underscore the importance of MU estimation in ensuring metrological traceability, fulfilling ISO 15189 accreditation requirements, and supporting risk-based quality management in clinical laboratories. This study highlights the practicality of ISO 20914 for routine MU assessment and advocates for its broader adoption to enhance result reliability and inter-laboratory comparability.
METHODS: The study calculated MU for 27 general chemistry analytes using the ISO 20914:2019 top-down approach, which uses long-term internal quality control (IQC) data and manufacturer calibrator traceability certificate values. The study was conducted at Nad al Hammar Health Center, Dubai Health, Dubai, using Roche Cobas Pure analyzers. The study compared calculated MU values with maximum allowable uncertainty (MAU) thresh-olds obtained from the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) biological variation database.
RESULTS: The results show that 17 analytes met the desirable MAU criteria at IQC level 1, confirming robust analytical performance. However, 10 analytes - including albumin, alkaline phosphatase, calcium, magnesium, phosphorus, transferrin, troponin T hs, uric acid, urine albumin, and vitamin D - exceeded the desirable MAU limits, suggesting potential areas for method optimization or high signal to noise ratio at quality control level 1.
CONCLUSIONS: The findings underscore the importance of MU estimation in ensuring metrological traceability, fulfilling ISO 15189 accreditation requirements, and supporting risk-based quality management in clinical laboratories. This study highlights the practicality of ISO 20914 for routine MU assessment and advocates for its broader adoption to enhance result reliability and inter-laboratory comparability.