Performance verification experiment for enzyme-linked immunosorbent assay in blood screening laboratory

Abstract

Objective To verificate the performance of enzyme-linked immunosorbent assay (ELISA) in blood screening laboratory. Methods The repeatability, precision, sensitivity, specificity, compliance, detection limit and anti-interference of ELISA items in the laboratory detection system were verified. Results The repeatability was 100%.The intra batch imprecision of each system was less than 10%, and the inter batch imprecision was less than 15%. The sensitivity, specificity and compliance were 100%, with the minimum detection limits of the two reagents at 0.75 NCU/mL and 0.25 NCU/mL respectively, The anti-interference met the requirements of the reagent manual. Conclusion The analysis of the performance verification data of ELISA test items will help continuously improve the performance of detection system and ensure the safety of clinical blood use.

Keywords

• performance verification
• detection system
• elisa