Analytical performance of an automated immunoassay for tissue inhibitor of me talloproteinases-1 (TIMP-1)

Tissue Inhibitor of Metalloproteinase-1 (TIMP-1) measurements may be clinically useful in colorectal cancer detection and management, cardiac disease risk assessment, and in liver fibrosis monitoring. The analytical performance for an automated ARCHITECT® TIMP-1 immunoassay was evaluated, including precision, on-board reagent stability, effect of interfering substances, specimen collection and handling, analytical sensitivity, linearity, recovery, manual vs. autodilution, high-dose hook effect, and reagent lot-to-lot agreement. Precision was evaluated over 20 days across 2 test sites, 3 instruments, and 3 reagent lots. Total concentration CVs for a plasma panel and for low, medium, and high controls were 2.3, 2.8, 3.2, and 5.3%, respectively. No interferences were observed for other TIMPs, common interferences, and chemotherapeutic compounds. TIMP-1 results in plasma from EDTA, heparin, and plasma separator tubes showed no significant difference (<10%). The ARCHITECT TIMP-1 assay demonstrated good analytical performance necessary for evaluation of TIMP-1 as a potential biomarker in disease management.