Validation of the KL6 Method on the G600II Analyser (Lumipulse) for Clinical Use in Interstitial Lung Disease.

Abstract

The Clinical Laboratory (CL) is involved in the prevention, diagnosis and follow-up of disease, as well as in the monitoring of treatment. For this reason, the CL must have robust quality systems in place in order to provide reliable results that help to ensure correct health care. Since the entry into force of the European regulation (IVDR) on in vitro diagnostic medical devices (EU) 2017/746 has generated the loss of CE marking in some laboratory determinations. In our case, Krebs von den Lungen-6 (KL-6), a diagnostic, severity and prognostic marker, as well as a marker of response to treatment, currently has the RUO (research use only) marking and, given its importance in our healthcare environment, we have validated the method with the new reagent in order to be able to continue with the clinical care of patients. In addition, this would keep this analyte within the scope of accreditation. Following the specific CLSI protocols, we carried out a study of precision, linearity as well as the limit of blank and the limit of detection, obtaining results within the limits established by the laboratory. This positive validation of KL6 allows us to continue using this analyte for clinical use and within the scope of accreditation.