Ping Loh, T, Smith, AF orcid.org/0000-0001-7709-1869, Bell, KJL et al. (6 more authors) (2021) Setting analytical performance specifications using HbA1c as a model measurand. Clinica Chimica Acta, 523. pp. 407-414. ISSN 0009-8981
Abstract
Analytical performance specifications (APS) for measurands describe the minimum analytical quality requirements for their measurement. These APS are used to monitor and contain the systematic (trueness/ bias) and random errors (precision/ imprecision) of a laboratory measurement to ensure the results are “fit for purpose” in informing clinical decisions about managing a patient’s health condition. In this review, we highlighted the wide variation in the setting of APS, using different levels of evidence, as recommended by the Milan Consensus, and approaches. The setting of a priori defined outcome-based APS for HbA1c remains challenging. Promising indirect alternatives seek to link the clinical utility of HbA1c and APS by defining statistical confidence for interpreting the laboratory values, or through simulation of clinical performance at varying levels of analytical performance. APS defined based on biological variation estimates in healthy individuals using the current formulae are unachievable by nearly all routine laboratory methods for HbA1c testing. On the other hand, the APS employed in external quality assurance programs have been progressively tightened, and greatly facilitate the improved quality of HbA1c testing. Laboratories should select the APS that fits their intended clinical use and should document the data and rationale underpinning those selections. Where possible common APS should be adopted across a region or country to facilitate the movement of patients and patient data across health care facilities.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2021 Elsevier B.V. All rights reserved. This is an author produced version of a review published in Clinica Chimica Acta. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | analytical performance speficiation; bias; external quality assurance; imprecision; proficiency testing; quality control; quality goal |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Leeds Institute of Health Sciences (Leeds) > Academic Unit of Health Economics (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 20 Oct 2021 08:59 |
Last Modified: | 16 Jan 2023 14:16 |
Status: | Published |
Publisher: | Elsevier |
Identification Number: | 10.1016/j.cca.2021.10.016 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:179391 |