Analytical and Clinical Performance Characteristics of Hybritech’s Tandem-R free PSA Assay during a Large Multicenter Clinical Trial to Determine the Clinical Utility of Percentage of Free Prostate-specific Antigen

Chan, Daniel W.; Kelley, Cynthia; Ratliff, Timothy L.; D’Agostino, D.; Ritchey, Julie; Lamb, Dolores J.; Beck, Josie; Lott, Nadean; Wener, Mark H.; Daum, Phyllis; Henkin, Robert E.; Kaske, Diane N.; Golightly, Debbie W.; McBride, James H.; Layco, Grace; Ota, May K.; Tanasijevic, Milenko J.; Grudzien, Christine; Woodrum, David L.; Bray, Kurtis R.; Southwick, Paula C.; Gasior, Gail H.; Loveland, Kathleen G.

doi:10.1093/clinchem/45.10.1863

Cited by 7 publications

(2 citation statements)

References 12 publications

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“…Previous studies had confirmed the value of f/tPSA in the diagnosis of PCa in patients with PSA levels in the grey zone, 19 in which a low f/tPSA predicted a high risk of PCa. 20 However, the value of f/tPSA in the diagnosis of PCa in patients with a PSA level in the grey zone in East Asia remains controversial. For example, a previous study found that the predictive value of f/tPSA in grey zone PCa diagnosis in Chinese people was low.…”

Section: Discussionmentioning

confidence: 99%

Significance of the prostate central gland and total gland volume ratio in the diagnosis of prostate cancer patients in the prostate specific antigen grey zone

Guo

Yang

et al. 2021

J Int Med Res

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Objective To explore the significance of the prostate central gland to total gland volume ratio (PVc/PV) in the diagnosis of prostate cancer (PCa) in patients with prostate specific antigen (PSA) levels in the grey zone (4–10 ng/ml). Methods This retrospective study enrolled patients that had undergone prostate biopsy. The volume of the prostate and the central prostate gland were measured. The differences in PSA, the ratio of free to total PSA (f/tPSA), PSA density (PSAD) and PVc/PV between the PCa and non-PCa groups were compared. Receiver operating characteristic curve analysis for PCa and clinically significant PCa (csPCa) diagnosis were calculated according to PSA (reference), f/tPSA, PSAD and PVc/PV. Results This study enrolled 136 patients. There was no significant difference in PSA and f/tPSA between the PCa and non-PCa groups, while there were significant differences in PSAD and PVc/PV. The area under the curve values of PVc/PV for PCa or csPCa diagnosis were 0.876 and 0.933, respectively; and for PSAD, they were 0.705 and 0.790, respectively. These were significantly different compared with the PSA curve, whereas f/tPSA showed no significant difference from the PSA curve. Conclusion PVc/PV could be a predictor of PCa when PSA is between 4–10 ng/ml.

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Section: Discussionmentioning

confidence: 99%

Significance of the prostate central gland and total gland volume ratio in the diagnosis of prostate cancer patients in the prostate specific antigen grey zone

Guo

Yang

et al. 2021

J Int Med Res

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show abstract

“…Previous studies had con rmed the value of f/tPSA in the diagnosis of PSA gray zone PCa, [8] in which low f/tPSA predicted a high risk of PCa. [9] However, the value of f/tPSA in the diagnosis of gray zone PCa in East Asia is still very controversial. Huang et al found that the predictive value of f/tPSA in gray zone PCa diagnosis in Chinese people was low, [10] Jeong et al [11] reported that f/tPSA did not improve the diagnostic accuracy of PSA gray zone PCa for Korean people aged 50-65 in a prospective multicenter study.…”

Section: Discussionmentioning

confidence: 99%

Significance of the Prostate Central Gland and Total Gland Volume Ratio in the Diagnosis of Prostate Cancer Patients in the PSA Gray Zone

Guo

Yang

et al. 2021

Preprint

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Objective: To explore the significance of the prostate central gland to total gland volume ratio in the diagnosis of PSA 4-10ng/ml prostate cancer (PCa) patients. Method: A retrospective analysis was performed on patients who had undergone prostate biopsy in our hospital from July 2015 to December 2020.The anteroposterior, transverse and axial diameters of the prostate and the central prostate gland were measured using multiparametric magnetic resonance imaging (mpMRI). The differences in PSA, f/tPSA, PSAD and PVc/PV between the PCa group and the non-PCa group were compared. ROC curves for PCa and clinically significant PCa (csPCa) diagnosis were drawn according to PSA, f/tPSA, PSAD and PVc/PV respectively. Corresponding PSA was used as the reference standard for comparison.Results: There was no statistically significant difference in PSA and f/tPSA between the two groups (P>0.05), while there were statistically significant differences in PSAD and PVc/PV between the two groups (P<0.05). By comparing the AUC values of the ROC curve for any PCa or csPCa, the AUC value of PVc/PV was 0.876 and 0.933, and PSAD was 0.705 and 0.790. This is significantly different from that of the PSA curve (P<0.05), whereas f/tPSA was 0.589 and 0.692 showing no significant difference from the PSA curve (P>0.05).Conclusion: Low volume ratio of central prostate gland PVc/PV has a higher incidence of PCa and csPCa, which can be used as an important reference index for the diagnosis of PCa in PSA 4-10 ng/ml patients.

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Electrochemical Immunoassay for Free Prostate Specific Antigen (f‐PSA) Using Magnetic Beads

et al. 2008

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Prostate specific antigen (PSA) is a prominent marker for the prostate carcinoma. It is found in human blood in free (f-PSA) and complex forms. These two forms together are called total PSA (t-PSA). Estimation of both forms is essential to predict malignancy. In this study we report a unique and effective technique of electrochemical detection of f-PSA using magnetic beads on a three-electrode screen-printed sensor. A magnetic bead enzyme linked immunosorbent assay (ELISA) was performed in a cuvette. Following the immunoassay, magnetic beads were recovered by a magnetic concentrator and transferred on the working electrode of the 3-electrode assembly. The amperometric response, a measure of the amount of residual enzyme activity on the beads and hence the concentration of analyte in solution, was determined by addition of enzyme substrate. The device has a detection limit of < 0.1 ng mL À1 f-PSA and a linear range of 0 to 1 ng mL À1 f-PSA.

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Analytical and Clinical Performance Characteristics of Hybritech’s Tandem-R free PSA Assay during a Large Multicenter Clinical Trial to Determine the Clinical Utility of Percentage of Free Prostate-specific Antigen

Cited by 7 publications

References 12 publications

Significance of the prostate central gland and total gland volume ratio in the diagnosis of prostate cancer patients in the prostate specific antigen grey zone

Significance of the prostate central gland and total gland volume ratio in the diagnosis of prostate cancer patients in the prostate specific antigen grey zone

Significance of the Prostate Central Gland and Total Gland Volume Ratio in the Diagnosis of Prostate Cancer Patients in the PSA Gray Zone

Electrochemical Immunoassay for Free Prostate Specific Antigen (f‐PSA) Using Magnetic Beads

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