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Abstract

Background: Measurement of the prostate specific antigen (PSA) remains an important tool in prostate cancer (PC) diagnosis. Due to limited availability of laboratory devices in an outpatient setting, compact and easy-to-handle point-of-care (POC) systems are desirable. Recently, a chip for PSA measurement on the concile® Ω100 POC reader platform was introduced. To investigate the clinical applicability, we evaluated the system in a consecutive cohort of patients undergoing PSA measurement in our outpatient clinic. Methods: Between 07/2014 and 01/2015, PSA was analyzed in a total of 198 patients by the POC reader system and in parallel by an Immulite 2000® and Centaur® standard laboratory system, respectively. By standard (Immulite®) measurement, 67 (34,2 %) had PSA > 4 ng/ml and 131 (65,8 %) had PSA ≤ 4 ng/ml. Results were correlated by linear regression analyses for all patients and within PSA subgroups. For patients with available prostate histology after PSA measurement (n = 68), receiver-operating characteristic curves were created and area under the curve (AUC), sensitivity and specificity for the prediction of PC at best cut-off value were calculated. Results: The coefficients of determination (r2) for the POC device compared to laboratory testing were 0.72 (Immulite®) and 0.63 (Centaur®), respectively (both p