Publications by authors named "Laurence Guis-Cabanne"
Article Synopsis
- The ISO 15189 accreditation requires that biological analysis reports include interpretations of the results.
- Interpreting autoimmunity tests can be tricky because biologists might lack clinical data, while clinicians may not know the technical challenges involved.
- A French group called EASI is providing tips for biologists to help them understand these results better, and it's important for biologists and clinicians to communicate for better patient care.
The ISO 15189 accreditation of biological analysis needs the validation of the analytical methods allowing the evaluation of their performance including all the factors that could influence the quality of their results. The field of autoimmunity includes many analyses and methods such as the indirect immunofluorescence technique (IIF) and the performance of this technique largely depends on the competency of staff members. For each staff member, the required levels of competency have to be precisely defined and evaluated after a period of formation before the final habilitation for the IIF technique.
View Article and Find Full Text PDFBackground: ISO 15189 accreditation remains a challenge for specialized laboratories. In the field of autoimmunity, beside the crucial problem of absence of standardization, laboratories have to manage the analytical performances of the large panel of assays in terms of sensitivity and specificity, but also on their measurement precision for which no reference values are available on biorepositories.
Methods: As an initiative of the French EASI (European Autoimmunity Standardization Initiative) group, French clinical diagnostic laboratories were requested to participate in a survey aiming to analyze the coefficients of variation (CVs) of intra-run and inter-run variability obtained with assays quantifying 14 different autoantibodies.