Transference and validation of reference intervals

Rather, for assays with established traceability, traceable assays should be used to both set and use the interval (6 ). [...]preliminary information gathered from the manufacturer, external quality assurance (EQA) programs, and other published data is a first step to determining an assay's tra...

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Bibliographic Details
Published in:Clinical chemistry (Baltimore, Md.) Md.), 2015-08, Vol.61 (8), p.1012-1015
Main Authors: Tate, Jillian R, Yen, Tina, Jones, Graham R D
Format: Article
Language:English
Subjects:
Advantages
Age
Architects
Bias
Blood Chemical Analysis - standards
Collaboration
Data mining
Female
Geriatrics
Hematology
Humans
Immunoassay
Laboratories
Local population
Male
Metabolic disorders
Pediatrics
Population
Quality assurance
Reference materials
Studies
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Summary:Rather, for assays with established traceability, traceable assays should be used to both set and use the interval (6 ). [...]preliminary information gathered from the manufacturer, external quality assurance (EQA) programs, and other published data is a first step to determining an assay's traceability claims and suitability for transfer of the reference interval. (9 ) did a similar method comparison in the Australasian harmonized reference interval study, in which aliquots of biobanked sera from healthy individuals were used to determine the bias between 8 major chemistry platforms in use throughout Australia and New Zealand.\n This method has advantages over the direct reference interval validation process by providing large amounts of data on the local population being tested and reflects the actual analytical and preanalytical conditions for the tested population.
ISSN:0009-9147
1530-8561
DOI:10.1373/clinchem.2015.243055