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

Gerard J. Davis, Philip M. Hemken, Willard Dunn, Sabrina S. Chan, Renu Dua, Lori J. Sokoll, Barry L. Dowell, Thomas T. Biegalski, Debra Elliott, Daniel W. Chan

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)70-76
Number of pages7
JournalJournal of Clinical Ligand Assay
Volume30
Issue number3-4
StatePublished - Sep 1 2007

Keywords

  • Biomarker
  • Colorectal cancer
  • Immunoassay development
  • TIMP-1

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

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    Davis, G. J., Hemken, P. M., Dunn, W., Chan, S. S., Dua, R., Sokoll, L. J., Dowell, B. L., Biegalski, T. T., Elliott, D., & Chan, D. W. (2007). Analytical performance of an automated immunoassay for tissue inhibitor of me talloproteinases-1 (TIMP-1). Journal of Clinical Ligand Assay, 30(3-4), 70-76.