Assessment of a new point-of-care system for detection of prostate specific antigen

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 (R) Omega 100 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 (R) and Centaur (R) standard laboratory system, respectively. By standard (Immulite (R)) 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 (r(2)) for the POC device compared to laboratory testing were 0.72 (Immulite (R)) and 0.63 (Centaur (R)), respectively (both p < 0.0001). In the PSA range of = 4 ng/ml, the observed correlations were 0.75 and 0.70, respectively. For the POC test system, AUC for detection of PC was calculated with 0.745 while the standard laboratory tests showed 0.778 (Immulite (R)) and 0.771 (Centaur (R)). At best cut-off of 3.64 ng/ml, PSA analysis by the POC system showed a sensitivity of 85.7 % and a specificity of 66.7 %. Conclusions: The POC system obtained good concordance to elaborate laboratory measurement. In a screening scenario, the system provides quick and reliable PSA measurement, especially in the PSA range up to 4 ng/ml.