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Related Concept Videos

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Related Experiment Video

Updated: Oct 16, 2025

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Setting analytical performance specifications using HbA1c as a model measurand.

Tze Ping Loh1, Alison F Smith2, Katy J L Bell3

  • 1Department of Laboratory Medicine, National University Hospital, Singapore.

Clinica Chimica Acta; International Journal of Clinical Chemistry
|October 19, 2021
PubMed
Summary
This summary is machine-generated.

Analytical performance specifications (APS) ensure lab test accuracy for clinical decisions. Setting APS for HbA1c is challenging, with variations in methods and evidence impacting patient care quality.

Keywords:
Analytical performance specificationBiasExternal quality assuranceImprecisionProficiency testingQuality controlQuality goal

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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Analytical Measurement

Background:

  • Analytical Performance Specifications (APS) define minimum quality requirements for laboratory measurements.
  • APS are crucial for monitoring systematic (trueness/bias) and random errors (precision/imprecision) to ensure results are "fit for purpose" in clinical decision-making.
  • Ensuring the analytical quality of laboratory tests is vital for effective patient health management.

Purpose of the Study:

  • To review the variation in setting APS, particularly for HbA1c.
  • To explore different approaches and evidence levels for APS determination, referencing the Milan Consensus.
  • To discuss challenges and alternatives for establishing outcome-based APS for HbA1c.

Main Methods:

  • Literature review of current practices and recommendations for setting APS.
  • Analysis of different methodologies for APS determination, including outcome-based and biological variation approaches.
  • Examination of the role of external quality assurance (EQA) programs in improving HbA1c testing quality.

Main Results:

  • Significant variation exists in the methods and evidence used to set APS.
  • Establishing a priori outcome-based APS for HbA1c is difficult, with indirect methods showing promise.
  • APS based on biological variation in healthy individuals are often unachievable for routine HbA1c testing.
  • External quality assurance programs have successfully driven improvements in HbA1c testing quality.

Conclusions:

  • Laboratories must select APS aligned with clinical use and document their rationale.
  • Common APS adoption across regions can improve patient data portability and healthcare consistency.
  • Continued efforts are needed to standardize and optimize APS setting for critical measurands like HbA1c.