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Enzyme immunoassay of immunoreactive progastrin-releasing peptide(31-98) as tumor marker for small-cell lung carcinoma: development and evaluation.

Abstract
Previously, using recombinant human progastrin-releasing peptide (ProGRP)(31-98), we developed a RIA for ProGRP(31-98) and demonstrated that the determination of serum ProGRP(31-98) was a reliable marker for small-cell lung carcinoma (SCLC) (Miyake et al., Cancer Res 1994;54:2136-40). Aiming for a more convenient assay system, we have now developed and evaluated a highly sensitive and specific ELISA for ProGRP(31-98). Only 50 microL of nonextracted serum is needed, and results are obtained in only 2 h. Intraassay and between-day CVs were 1.7-4.6% and 4.2-6.8%, respectively. The log-log calibration curve was linear to 1000 ng/L, and analytical recovery was 91.5-108.7%. The detection limit of this assay, 1.9 ng/L, means that basal concentrations of ProGRP(31-98) were detectable in all healthy subjects. The cutoff value, based on the mean + 3 SD of concentrations in 247 healthy subjects, was set to 45.1 ng/L. Serum concentrations exceeded this value in 18 of 25 SCLC patients, similar to the frequency of increased values found by RIA previously. In contrast, the frequency of increased serum ProGRP(31-98) in patients with nonmalignant pulmonary diseases or non-SCLC was quite low: 0% and 5.0%, respectively. Such results may justify a clinical trial for evaluating this ELISA for the diagnosis and monitoring of SCLC patients.
AuthorsK Aoyagi, Y Miyake, K Urakami, T Kashiwakuma, A Hasegawa, T Kodama, K Yamaguchi
JournalClinical chemistry (Clin Chem) Vol. 41 Issue 4 Pg. 537-43 (Apr 1995) ISSN: 0009-9147 [Print] England
PMID7720242 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Antibodies, Monoclonal
  • Biomarkers, Tumor
  • Peptide Fragments
  • Peptides
  • Recombinant Proteins
  • pro-gastrin-releasing peptide (31-98)
  • Biotin
Topics
  • Amino Acid Sequence
  • Antibodies, Monoclonal
  • Base Sequence
  • Biomarkers, Tumor (blood)
  • Biotin
  • Carcinoma, Small Cell (blood)
  • Enzyme-Linked Immunosorbent Assay (statistics & numerical data)
  • Humans
  • Lung Neoplasms (blood)
  • Microchemistry
  • Molecular Sequence Data
  • Peptide Fragments (blood, chemistry, genetics)
  • Peptides (blood, chemistry, genetics)
  • Recombinant Proteins (analysis, blood, chemistry, genetics)
  • Reference Values
  • Sensitivity and Specificity

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