A novel method to detect hPG₈₀ (human circulating progastrin) in the blood

hPG₈₀ (human circulating progastrin) is produced and released by cancer cells. We recently reported that hPG₈₀ is detected in the blood of patients with cancers from different origins, suggesting its potential utility for cancer detection. To accurately measure hPG₈₀ in the blood of patients, we developed the DxPG₈₀ test, a sandwich Enzyme-Linked Immunosorbent Assay (ELISA). This test quantifies hPG₈₀ in EDTA plasma samples. The analytical performances of the DxPG₈₀ test were evaluated using standard procedures and guidelines specific to ELISA technology. We showed high specificity for hPG₈₀ with no cross-reactivity with human glycine-extended gastrin (hG17-Gly), human carboxy-amidated gastrin (hG17-NH₂) or the CTFP (C-Terminus Flanking Peptide) and no interference with various endogenous or exogenous compounds. The test is linear between 0 and 50 pM hPG₈₀ (native or recombinant). We demonstrated a trueness of measurement, an accuracy and a variability of hPG₈₀ quantification with the DxPG₈₀ test below the 20% relative errors as recommended in the guidelines. The limit of detection of hPG₈₀ and the limit of quantification were calculated as 1 pM and 3.3 pM respectively. In conclusion, these results show the strong analytical performance of the DxPG₈₀ test to measure hPG₈₀ in blood samples.