1. Assessment of a new point-of-care system for detection of prostate specific antigen.
- Author
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Rausch, Steffen, Hennenlotter, Joerg, Wiesenreiter, Josef, Hohneder, Andrea, Heinkele, Julian, Schwentner, Christian, Stenzl, Arnulf, and Todenhöfer, Tilman
- Subjects
POINT-of-care testing ,PROSTATE-specific antigen ,DIAGNOSIS ,PROSTATE cancer ,REGRESSION analysis ,SUBGROUP analysis (Experimental design) ,RECEIVER operating characteristic curves ,SENSITIVITY & specificity (Statistics) ,PSYCHOLOGICAL adaptation ,BLOOD coagulation factors ,CLINICAL medicine ,MEDICAL databases ,INFORMATION storage & retrieval systems ,LONGITUDINAL method ,PHARMACOKINETICS ,PROSTATE tumors ,PSYCHOLOGICAL tests ,RESEARCH evaluation ,EARLY detection of cancer - 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 (r(2)) for the POC device compared to laboratory testing were 0.72 (Immulite®) and 0.63 (Centaur®), 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®) and 0.771 (Centaur®). 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. [ABSTRACT FROM AUTHOR]- Published
- 2016
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