Proguanylin and prouroguanylin--assay evaluation and clinical analyte characterization

Abstract

Background: The biomarkers proguanylin and prouroguanylin are members of the natriuretic peptide family. The aim of this study was to evaluate two commercially available assays for proguanylin and prouroguanylin and to further characterize both analytes in terms of important clinical features.

Methods: We evaluated precision and linearity of the BioVendor human proguanylin and prouroguanylin ELISAs. In order to characterize both analytes, we tested in vitro analyte stabilities at -80 °C, and determined biological variability and reference values for proguanylin and prouroguanylin.

Results: Within-run and total coefficients of variation were <10% for the BioVendor proguanylin and prouroguanylin assays. Both methods were linear across the tested measurement ranges. The analytes proguanylin and prouroguanylin were stable for at least 2 months at -80 °C. With respect to biological variability, the reference change values (RCV) were 27% and 59% for proguanylin and prouroguanylin, respectively. For proguanylin, age-independent reference values were 4.0-13.4 ng/mL in males and 4.6-16.3 ng/mL in females. For prouroguanylin, age- and sex-independent reference values were 2.1-11.2 ng/mL.

Conclusion: The BioVendor human proguanylin ELISA and the BioVendor human prouroguanylin ELISA meet the needs of quality specifications of laboratory medicine. The results of the characterization of both analytes provide essential information for further clinical studies.