Analytical and Clinical Assessment of Prostate Specific Antigen Using an HISCL-5000 Chemiluminescence Immunoassay
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Background: Prostate cancer (PCa) is the leading cause of cancer-related death worldwide. Prostate specific antigen (PSA) is a useful biomark- er that can be screened for the diagnosis and prognosis of PCa. We evaluated the analytical performance of the PSA test using an HISCL-5000 im- munoassay (Sysmex, Japan). Methods: The analytical and clinical evaluation of PSA was performed using an HISCL-5000 chemiluminescent enzyme immunoassay. For analyz- ing the precision, linearity, trueness, limit of detection (LOD), limit of blank (LOB) and for comparing the method with UniCel DxI-800 ACCESS (Beck- man Coulter, USA), 510 samples of PSA were collected. Clinical analyses were performed for benign prostate hyperplasia (BPH) and PCa. The area under the receiver operating characteristic curve (AUROC) was used for evaluating the diagnostic potential. Results: The within-laboratory coefficient of variation (CV) for low- (3.81 ng/mL) and high- (18.19 ng/mL) level PSA was 5.46% and 8.50%, re- spectively. Linearity was verified from 0.002 to 189.900 ng/mL for PSA. LOB and LOD were 0.007 and 0.020 ng/mL, respectively. Bias between the expected true and measured values was -9.70-11.16%. The regression equation by method comparison was y = -1.0605+0.9223x (R2 = 0.99). AUROC values for diagnosis of PCa and BPH compared to non-malignant disease were 0.52 and 0.75, respectively. When compared to healthy sub- jects, AUROC values were 0.96 and 0.97, respectively. Conclusions: PSA analysis using an HISCL-5000 immunoassay is reliable and can be used in clinical settings.
Abstract
Background: Prostate cancer (PCa) is the leading cause of cancer-related death worldwide. Prostate specific antigen (PSA) is a useful biomark- er that can be screened for the diagnosis and prognosis of PCa. We evaluated the analytical performance of the PSA test using an HISCL-5000 im- munoassay (Sysmex, Japan). Methods: The analytical and clinical evaluation of PSA was performed using an HISCL-5000 chemiluminescent enzyme immunoassay. For analyz- ing the precision, linearity, trueness, limit of detection (LOD), limit of blank (LOB) and for comparing the method with UniCel DxI-800 ACCESS (Beck- man Coulter, USA), 510 samples of PSA were collected. Clinical analyses were performed for benign prostate hyperplasia (BPH) and PCa. The area under the receiver operating characteristic curve (AUROC) was used for evaluating the diagnostic potential. Results: The within-laboratory coefficient of variation (CV) for low- (3.81 ng/mL) and high- (18.19 ng/mL) level PSA was 5.46% and 8.50%, re- spectively. Linearity was verified from 0.002 to 189.900 ng/mL for PSA. LOB and LOD were 0.007 and 0.020 ng/mL, respectively. Bias between the expected true and measured values was -9.70-11.16%. The regression equation by method comparison was y = -1.0605+0.9223x (R2 = 0.99). AUROC values for diagnosis of PCa and BPH compared to non-malignant disease were 0.52 and 0.75, respectively. When compared to healthy sub- jects, AUROC values were 0.96 and 0.97, respectively. Conclusions: PSA analysis using an HISCL-5000 immunoassay is reliable and can be used in clinical settings.
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