This study introduces a completely Random Quality Control (R-QC) method for Enzyme-Linked Immunosorbent Assay (ELISA) tests and compares it with traditional Fixed Quality Control (F-QC) methods across different testing items. A random quality control system was constructed using a Time-series model, enabling fully random positioning of quality control in ELISA tests. The Coefficient of Variation (CV) for R-QC were found to be lower as compared to F-QC in Hepatitis B surface antigen (HBsAg), anti-Human Immunodeficiency Virus (anti-HIV), and Treponema Pallidum (TP) items, and there were significant differences among them. Moreover, the alarm rates and out of control rates in the R-QC groups were notably lower than those in the F-QC groups. The experimentally designed R-QC method demonstrates superior stability, reducing alarm and out of control rates, with has significant implications for improving ELISA testing at the Nanjing Blood Center.
