Characteristics and clinical validity of two immunoassays for ProGRP

Tumour Biol. 2012 Aug;33(4):1105-13. doi: 10.1007/s13277-012-0351-1. Epub 2012 Mar 8.

Abstract

Progastrin-releasing peptide (proGRP) is a promising serum tumor marker for small cell lung cancer (SCLC). We have tested assay specificity and performed a correlation study between a recently developed time-resolved immunofluorometric assay (TR-IFMA) for proGRP and the established Advanced Life Science Institute (ALSI) ELISA method. Between-method correlation and comparison of clinical performance were studied in 481 individuals, among them, 178 lung cancers, 84 benign diseases of the lung, and 219 healthy controls. Follow-up time >6 years was observed for 89 patients with SCLC. The two assays had quite different epitope specificities where the TR-IFMA recognized a considerable smaller proGRP fragment than the ALSI ELISA. However, the correlation between the two methods for elevated proGRP values (>85 ng/l) was good (ρ = 0.948). Both assays displayed good discrimination between benign lung diseases and SCLC. The cut-off values for positive classification of SCLC versus non-small cell lung cancers and benign lung diseases at >95% specificity were 85 ng/l for the TR-IFMA and 42 ng/l for the ALSI ELISA. Both proGRP assays showed good clinical validity. However, due to differences in the recommended cut-off values, switching methods is not recommended. There was a significant difference in survival of patients with TR-IFMA proGRP values over the cut-off (85 ng/l) compared with patients with values under the cut-off, p = 0.0002. In contrast, the ALSI ELISA assay failed to provide statistically significant prognostic information, p = 0.066.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amino Acid Sequence
  • Carcinoma, Non-Small-Cell Lung / diagnosis
  • Carcinoma, Non-Small-Cell Lung / metabolism
  • Diagnosis, Differential
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Fluoroimmunoassay / methods*
  • Humans
  • Lung / chemistry*
  • Lung / pathology
  • Lung Diseases / diagnosis
  • Lung Diseases / metabolism
  • Lung Neoplasms / diagnosis
  • Lung Neoplasms / metabolism
  • Molecular Sequence Data
  • Peptide Fragments / analysis*
  • Prognosis
  • Recombinant Proteins / analysis
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Small Cell Lung Carcinoma / diagnosis
  • Small Cell Lung Carcinoma / metabolism

Substances

  • Peptide Fragments
  • Recombinant Proteins
  • pro-gastrin-releasing peptide (31-98)