Prada de Medio E.,Grupo Of Trabajo Interdisciplinar Of Calidad En El Laboratorio Clinico |
Blazquez Sanchez R.,Grupo Of Trabajo Interdisciplinar Of Calidad En El Laboratorio Clinico |
Perich Alsina C.,Grupo Of Trabajo Interdisciplinar Of Calidad En El Laboratorio Clinico |
Gutierrez Bassini G.,Grupo Of Trabajo Interdisciplinar Of Calidad En El Laboratorio Clinico |
And 10 more authors.
Revista del Laboratorio Clinico | Year: 2014
A fairly common situation in clinical laboratories is the existence of different analyzers used interchangeably for determining the same tests. It must be ensured that the level of agreement between the results obtained is independent of the systems or analytical platforms used, and that the measurements are comparable. Otherwise, we can create clinician misunderstanding and a possible misinterpretation of the results. Safety of the patient may be at risk.For this reason, this workgroup established two different situations: implementation of new equipment and review of previously verified equipment. In the first case, an analysis of the differences should be performed using the biological variability (VB) as a means to establish the maximum difference allowed. When VB data are not available, the statistical criterion should used for this calculation. A second possibility would be the use of linear regression for the study of comparability of analyzers.The use of the Clinical and Laboratory Standards Institute Protocol (CLSI), which allows up to 10 analyzers to be verified with a maximum of 2 analytical series, is proposed in the case of previously checked equipment.If the results provided by the different analyzers do not exceed the maximum deviation established, they would be considered as a single virtual equipment, otherwise, the results are not interchangeable, and the laboratory report should indicate clearly the analyzer used in each patient, as well as the appropriate reference range. © 2014 AEBM, AEFA y SEQC.