hPG(80) (human circulating progastrin) is produced and released by cancer cells. We recently reported that hPG(80) is detected in the blood of patients with cancers from different origins, suggesting its potential utility for cancer detection. To accurately measure hPG(80) in the blood of patients, we developed the DxPG(80) test, a sandwich Enzyme-Linked Immunosorbent Assay (ELISA). This test quantifies hPG(80) in EDTA plasma samples. The analytical performances of the DxPG(80) test were evaluated using standard procedures and guidelines specific to ELISA technology. We showed high specificity for hPG(80) 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 hPG(80) (native or recombinant). We demonstrated a trueness of measurement, an accuracy and a variability of hPG(80) quantification with the DxPG(80) test below the 20% relative errors as recommended in the guidelines. The limit of detection of hPG(80) 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 DxPG(80) test to measure hPG(80) in blood samples.
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