PROCEDURE FOR STUDYING COMMUTABILITY VALIDATED BY BIOLOGICAL VARIATION

Citation
C. Ricos et al., PROCEDURE FOR STUDYING COMMUTABILITY VALIDATED BY BIOLOGICAL VARIATION, Clinica chimica acta, 268(1-2), 1997, pp. 73-83
Citations number
28
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Medical Laboratory Technology",Biology
Journal title
ISSN journal
0009-8981
Volume
268
Issue
1-2
Year of publication
1997
Pages
73 - 83
Database
ISI
SICI code
0009-8981(1997)268:1-2<73:PFSCVB>2.0.ZU;2-M
Abstract
In the field of laboratory medicine, the two quantitative approaches d esigned to identify the stabilized materials that produce results that are commutable with results from patients' samples were found to diff er. In commutability evaluations, the responses of each material and e ach method studied are specific, thus, it is vital to standardise the procedure used for determining this characteristic. We incorporated st atistical components from the two described methods that seemed to be consistent, and added a new element based on biological variation, to validate the criterion of acceptability that determines whether or not a material is commutable. The three methods for studying commutabilit y (using the confidence interval [alpha = 0.05], the +/-2s(yx) formula , and the limit based on biological variation as acceptability criteri a) were applied to creatinine results from 31 stabilised materials and serum samples analysed with seven instruments, when compared against a reference method for creatinine analysis. Over the wide range of con centrations studied, the confidence interval limit and the biological variation limit coincided in the identification of commutable material s, whereas the +/- 2s(yx) was excessively permissive at normal and low concentration levels. We therefore recommend the use of Passing-Bablo k regression with its confidence interval (alpha = 0.05) in studies co ncerning commutability, Using this method, commutability is simple to calculate with available software and, as validated by biological vari ation, results are reliable. (C) 1997 Elsevier Science B.V.