Verification of examination procedures for 72 biochemical parameters on the atellica® clinical chemistry and immunoassay analyzers.

ABSTRACT

The verification of examination procedures is a responsibility for clinical laboratories in order to guarantee that their performance characteristics comply with the specifications obtained during the validation process and are congruent with the intended scope of the assay. The aim was to perform an evaluation of precision, bias, linearity, linear drift, sample carry-over, and comparability of 73 assays from Siemens Healthineers, by following the CLSI EP10-A3 guidelines. The verification was performed by measuring 72 biochemical parameters in quality control (QC) materials from Bio-Rad (except for IL6) with 73 assays installed on eight measuring systems (five Atellica® CH 930 and three IM 1600 analyzers from Siemens Healthcare Diagnostics). The following information was collected validation data from manufacturer, biological variation data from the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) database, and specifications for fßhCG and PAPP-A assays to meet the Fetal Medicine Foundation standards. A total of 17550 results were obtained during EP10 verification process. Out of the 73 methods, only Cl-S, Mg-S, and Na-S failed the criteria for adequate precision, trueness, and comparability. The assays did not show significant loss of linearity, linear drift, or sample carry-over. This study allowed the initial training and familiarization with the instruments and the identification of operational issues. It also represented an opportunity to evaluate the QCs and to obtain analytical performance information for application of sigma six metrics for quality assurance. Professionals are advised to adequately standardize and protocolize their verification processes to ensure laboratory competence and patient safety.