Objectives: Sigma metrics in an invaluable and inexpensive tool used in laboratories to monitor analytical quality of the assays. Alinity ci platform is a relatively recent analytical system launched by Abbott Diagnostics, and as such performance studies on it are few. We have calculated sigma metrics of 39 clinical chemistry and immunoassay analytes on two Alinity ci systems.
Methods: Sigma metrics were calculated using results of method validation studies. Coefficient of variation (CV) was calculated according to CLSI EP 15 guidelines. Bias was calculated using three different methods i.e., proficiency testing material, alternate method comparison with existent analyzers and linearity experiment. Total allowable error limits were kept similar to or less than the ones used in reference studies.
Results: All analytes except blood urea nitrogen (BUN) demonstrated greater than six sigma value across one or more levels and methods. No analyte amongst clinical chemistry and immunoassays was at below three sigma class. Amongst electrolytes, sodium was below three sigma class at two levels by proficiency testing method, although it was above four sigma class by other two methods. Sigma levels obtained were comparable to those reported in previously published studies.
Conclusions: Acceptable sigma metrics were achieved for all clinical chemistry, immunoassays and electrolytes on Alinity ci. Sigma metrics is an objective and well established cost effective tool to tailor internal quality control practices. This study determines sigma metrics for a wide range of high throughput assays. Long term assay performance needs to be monitored.
Keywords: accuracy; performance specifications; precision; six sigma; validation.
© 2021 Fatima Zehra Kanani et al., published by De Gruyter, Berlin/Boston.