Skip to content
Licensed Unlicensed Requires Authentication Published by De Gruyter October 13, 2009

Development and analytical performance evaluation of an automated chemiluminescent immunoassay for pro-gastrin releasing peptide (ProGRP)

  • Toru Yoshimura , Kenju Fujita , Hideki Kinukawa , Yoshiharu Matsuoka , Rahul D. Patil , Gangamani S. Beligere , Sabrina S. Chan , Barry L. Dowell , Lori Sokoll , Debra Elliott , Daniel W. Chan , Cornelia Scheuer , Karin Hofmann , Petra Stieber , Yousuke Sakurai , Masayuki Iizuka , Haruhisa Saegusa and Ken Yamaguchi

Abstract

Background: Pro-gastrin releasing peptide (ProGRP) concentrations in blood play an important role in the diagnosis and treatment of patients with small cell lung cancer (SCLC). The automated quantitative ARCHITECT® ProGRP assay was developed to aid in the differential diagnosis and in the management of SCLC. The purpose of this study was to evaluate the analytical performance of this chemiluminescent microparticle immunoassay at multiple sites.

Methods: ARCHITECT ProGRP measures ProGRP using a two-step sandwich using monoclonal anti-ProGRP antibodies coated on paramagnetic microparticles and labeled with acridinium. Analytical performance of the assay was evaluated at four sites: Abbott Japan, Denka Seiken, the Johns Hopkins University, and the University of Munich.

Results: Total precision (%CV) for nine analyte concentrations was between 2.2 and 5.7. The analytical sensitivity of the assay was between 0.20 pg/mL and 0.88 pg/mL. The functional sensitivity at 20% CV was between 0.66 pg/mL and 1.73 pg/mL. The assay was linear up to 50,000 pg/mL using a 1:10 autodilution protocol. The calibration curve was stable for 30 days. Comparison with the Fujirebio microtiter plate enzyme-linked immunosorbent assay (EIA) ProGRP assay gave a slope of 0.93 and a correlation coefficient (r) of 0.99.

Conclusions: These results demonstrate that the ARCHITECT ProGRP assay has excellent sensitivity, precision, and correlation to a reference method. This assay provides a convenient automated method for ProGRP measurement in serum and plasma in hospitals and clinical laboratories.

Clin Chem Lab Med 2009;47:1557–63.


Corresponding author: Toru Yoshimura, Research and Development, Diagnostics Division, Abbott Japan, 278 Matsuhidai, Matsudo, Chiba, Japan Phone: +81-47-386-4805, Fax: +81-47-386-4257,

Received: 2009-5-13
Accepted: 2009-8-11
Published Online: 2009-10-13
Published in Print: 2009-12-01

©2009 by Walter de Gruyter Berlin New York

Downloaded on 29.3.2024 from https://www.degruyter.com/document/doi/10.1515/CCLM.2009.333/html
Scroll to top button