Multicenter application and evaluation of automated quality control systems on fully automated assembly lines

To conduct a multi-center evaluation of the applicability of automated quality control (QC) on fully automated laboratory lines.

This study assessed the stability and out-of-control rates of both automated and manual QC for 12 biochemical parameters and 11 immunological parameters across 13 hospitals from different regions of China, between January 2021 and July 2021.

Compared to manual QC, which typically requires around 30 min, automated QC significantly reduced processing time to approximately 10 min. Performance comparisons across 23 test items covering 57 testing levels showed no statistically significant difference in sigma (σ) values between automated and manual QC, with both methods achieving σ ≥ 6 in two testing levels of the HCG assay. Additionally, automated QC demonstrated lower out-of-control rates than manual QC: 2.95 % vs. 3.77 % for biochemical tests and 1.54 % vs. 3.10 % for immunoassay tests. Homogeneity analysis revealed that the absolute Bias% between automated and manual QC results within regional peer groups was consistently less than one-quarter of the total allowable error (TEa), indicating good consistency. However, the BIO-RAD peer group showed slightly higher average Bias% values (4.97 %-5.11 %) for both QC methods compared to regional peer groups.

Automated QC demonstrated good consistency with manual QC and met laboratory quality requirements, optimizing internal QC processes. The standardization of automated QC procedures reduced out-of-control rates. Furthermore, automated QC had significant value in promoting the homogeneity of medical test results.