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, Ken Yamaguchi

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)1557-1563
Number of pages7
JournalClinical Chemistry and Laboratory Medicine
Volume47
Issue number12
DOIs
StatePublished - Dec 1 2009

Keywords

  • Automated immunoassay
  • Chemiluminescent microparticle immunoassay
  • Pro-gastrin releasing peptide
  • Small cell lung cancer
  • Tumor marker

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

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    Yoshimura, T., Fujita, K., Kinukawa, H., Matsuoka, Y., Patil, R. D., Beligere, G. S., Chan, S. S., Dowell, B. L., Sokoll, L., Elliott, D., Chan, D. W., Scheuer, C., Hofmann, K., Stieber, P., Sakurai, Y., Iizuka, M., Saegusa, H., & Yamaguchi, K. (2009). Development and analytical performance evaluation of an automated chemiluminescent immunoassay for pro-gastrin releasing peptide (ProGRP). Clinical Chemistry and Laboratory Medicine, 47(12), 1557-1563. https://doi.org/10.1515/CCLM.2009.333