B-278 Pilot Clinical Study of the CarePoint Assay

Abstract Background An estimated >710 000 individuals live with bladder cancer in the United States, approximately 82 290 new cases expected this year (2023). Recurrence rates for are high: 65% of patients non-invasive or situ tumors and 73% more advanced disease experience recurrence within five years. Consequently, treated require prolonged surveillance to safeguard against tumor recurrence. The gold standard surveillance, cystoscopy—an uncomfortable, expensive, invasive procedure—is recommended every three 12 months. there is a need an inexpensive, effective, noninvasive diagnostic tool as alternative cystoscopy. CarePoint Assay (CPA) 30-minute electrochemical immunoassay detection disease-state biomarkers human urine. analytical performance CPA has been evaluated method comparison three-hour sandwich immunosorbent assay (ELISA) antigen (BTA), biomarker cancer. Method Receiver operating characteristic (ROC) curves were calculated by simple logistic regression Prism9 (GraphPad) using patient urine samples across multiple medical centers (n = 51), comparing BTA concentration (continuous variable) high-grade status (binary variable). Patient commercial potentiostats ELISA. data was analyzed linear regression. Results interpolated three-point calibration spiked into pooled from healthy donors. Data produced ELISA five-parameter nonlinear 12-point curve. Both methods showed good correlation: (r) 0.93. Simple analyte sensitivity specificity 52% 88% AUROC 0.71 CPA, 72% 77% 0.77 Sensitivities specificities Youden’s J statistic. Conclusions We established proof concept rapid, correlated well ELISA, measuring bodily fluids. Future work will focus on refinement architecture point-of-care use subsequent evaluation performance.