Abstract
OBJECTIVE: To evaluate a newly developed Hybiome ProGRP chemiluminescent assay. METHODS: Analytical sensitivity, precision, recovery, and equivalency of serum and plasma, serum stability, and complement interference of the Hybiome ProGRP assay were evaluated. Serum specimens from 318 individuals including 38 small cell lung cancer (SCLC), 65 non-small cell lung cancer (NSCLC), 53 benign lung diseases, and 162 healthy controls were assessed using the Hybiome ProGRP assay and Roche Elecsys ProGRP assay, and the results were compared. RESULTS: The Hybiome ProGRP assay showed good analytical sensitivity, precision, and accuracy, and it showed equivalence between serum and plasma and serum stability. The methodological comparison results showed good correlation between the Hybiome and Roche assays (slope, 0.9889; intercept, 1.28). Both the Hybiome and Roche assays showed good ability to distinguish between SCLC and NSCLC. Based on 95% specificity in the NSCLC cohort, a clinical differentiation cut-off for separating SCLC from NSCLC patients was 114 pg/mL for the Hybiome assay and 117 pg/mL for the Roche assay; the AUC was 0.9166 and the sensitivity was 71.05% for Hybiome and 0.9045 and 76.32% for Roche, respectively. CONCLUSION: The Hybiome ProGRP chemiluminescent assay shows good analytical performance and good correlation with the Roche Elecsys ProGRP assay.