Fig. 6.

Clinical utility of TEX101 ELISA as a test to evaluate vasectomy success, differentiate between non-obstructive azoospermia (NOA) and obstructive azoospermia (OA), and predict the success of sperm retrieval in patients with NOA. A cut-off value of 0.9 ng/mL provided 100% sensitivity at 100% specificity, with an area under the Receiver Operating Characteristic curve (ROC AUC) of 1.00 (95% CI 1.00–1.00), for distinguishing pre- and post-vasectomy men. A combination of TEX101 ≥ 0.9 ng/mL with epididymis-specific protein ECM1 ≥ 2.3 μg/mL provided 81% sensitivity at 100% specificity to differentiate between NOA and OA. A TEX101 cut-off value of ≥0.6 ng/mL provided 73% sensitivity at 64% specificity and ROC AUC of 0.69 (95% CI 0.48–0.89) to predict sperm retrieval in patients with NOA. NPV negative predictive value, PPV positive predictive value