Clinical decision limits as criteria for setting analytical performance specifications for laboratory tests.
Analytical performance specification
Biological variation
Clinical performance
Clinically significant difference
Diagnostic variation
Journal
Clinica chimica acta; international journal of clinical chemistry
ISSN: 1873-3492
Titre abrégé: Clin Chim Acta
Pays: Netherlands
ID NLM: 1302422
Informations de publication
Date de publication:
01 Feb 2023
01 Feb 2023
Historique:
received:
02
09
2022
revised:
17
01
2023
accepted:
18
01
2023
pubmed:
25
1
2023
medline:
22
2
2023
entrez:
24
1
2023
Statut:
ppublish
Résumé
The biological (CV The sum of the CV The obtained CAAPS were 44.9% for urine albumin, 0.6% for plasma sodium, 22.9% for plasma pancreatic amylase, and 8.0% for plasma creatinine (z = 3, α = 2.5%, 1-β = 85%). For blood HbA The CAAPS models pose a new tool for assessing APS in a clinical laboratory. Their usability depends on the relevance of CD limits, required statistical power and the feasibility of repeated measurements.
Sections du résumé
BACKGROUND
BACKGROUND
The biological (CV
METHODS
METHODS
The sum of the CV
RESULTS
RESULTS
The obtained CAAPS were 44.9% for urine albumin, 0.6% for plasma sodium, 22.9% for plasma pancreatic amylase, and 8.0% for plasma creatinine (z = 3, α = 2.5%, 1-β = 85%). For blood HbA
CONCLUSIONS
CONCLUSIONS
The CAAPS models pose a new tool for assessing APS in a clinical laboratory. Their usability depends on the relevance of CD limits, required statistical power and the feasibility of repeated measurements.
Identifiants
pubmed: 36693582
pii: S0009-8981(23)00026-8
doi: 10.1016/j.cca.2023.117233
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
117233Informations de copyright
Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.