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Analytical performance of a new one-step quantitative prostate-specific antigen assay, the FREND™ PSA Plus

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Published/Copyright: December 7, 2013
Clinical Chemistry and Laboratory Medicine
From the journal Clinical Chemistry and Laboratory Medicine Volume 52 Issue 5

Abstract

Background: We evaluated the analytical performance of a new one-step rapid quantitative sandwich immunoassay for total prostate-specific antigen (tPSA), the FREND™ PSA Plus (FREND PSA) (NanoEnTek Inc., Seoul, Korea).

Methods: The imprecision, linearity, hook effect, detection limit (LoD), and interference were evaluated and trueness verification and matrix validation were performed. For method comparison, 79 patient specimens were analyzed with FREND PSA and two comparative tPSA assays (Architect® total PSA and cobas® total PSA assay).

Results: Total CVs of the imprecision for low (0.208 ng/mL), medium (4.051 ng/mL), and high PSA levels (5.469 ng/mL) were 15.9%, 6.4%, and 9.1%, respectively. Linearity was observed from 1.01 to 19.15 ng/mL and the hook phenomenon was absent up to 171.48 ng/mL. The LoD was 0.094 ng/mL. The regression equations between FREND (y) and Architect or cobas were as follows: y=0.0133+1.054x (r=0.973), y=–0.2144+1.066x (r=0.977), respectively. Differences between FREND PSA and the comparative methods at a medical decision level of 4.0 ng/mL were less than the optimum specification bias (9.3%). The percentage biases from the trueness verification and interference test were less than the desirable specifications for bias (18.7%). The plasma tPSA level measured with lithium heparin or K2EDTA was comparable to that in the serum.

Conclusions: The FREND PSA provided reliable analytical performance and test results in comparison to two widely used tPSA assays. It is a simple and rapid test for tPSA and can be applied in point-of-care testing.

Keywords: FREND™ PSA Plus; rapid quantitative immunoassay; total prostate-specific antigen
Corresponding author: Seungok Lee, Department of Laboratory Medicine, Incheon St. Mary’s Hospital, The Catholic University of Korea, 56 Dongsu-ro, Bupyeong-gu, Incheon, 403-720, Republic of Korea, Phone: +82 32 2805512, Fax: +82 32 2805520, E-mail:

Acknowledgments

This study was supported by a grant from the Korea Medical Devices Industrial Coop. Association, Korea (2011).

Conflict of interest statement

Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research support played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

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Received: 2013-7-15
Accepted: 2013-10-31
Published Online: 2013-12-7
Published in Print: 2014-5-1

©2014 by Walter de Gruyter Berlin/Boston

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https://doi.org/10.1515/cclm-2013-0545
Keywords for this article
FREND™ PSA Plus; rapid quantitative immunoassay; total prostate-specific antigen

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Potential application of fetal epigenetic markers on the non-invasive prenatal detection of chromosomal abnormality
  4. Review
  5. Epigenetic mechanisms in bone
  6. Opinion Papers
  7. Circulating fetal cell-free DNA and prenatal molecular diagnostics: are we ready for consensus?
  8. Hepcidin levels in chronic hemodialysis patients: a critical evaluation
  9. D-dimer testing for suspected venous thromboembolism in the emergency department. Consensus document of AcEMC, CISMEL, SIBioC, and SIMeL
  10. General Clinical Chemistry and Laboratory Medicine
  11. Effect of biobanking conditions on short-term stability of biomarkers in human serum and plasma
  12. Non-invasive detection of fetal trisomy 21 using fetal epigenetic biomarkers with a high CpG density
  13. Development and validation of dried matrix spot sampling for the quantitative determination of amyloid β peptides in cerebrospinal fluid
  14. Instability of cerebrospinal fluid after delayed storage and repeated freezing: a holistic study by drop coating deposition Raman spectroscopy
  15. Analysis of patients with γ-heavy chain disease by the heavy/light chain and free light chain assays
  16. Performance of urinary NGAL and L-FABP in predicting acute kidney injury and subsequent renal recovery: a cohort study based on major surgeries
  17. Rapid extraction, identification and quantification of drugs of abuse in hair by immunoassay and ultra-performance liquid chromatography tandem mass spectrometry
  18. Validity and reliability of the 13C-methionine breath test for the detection of moderate hyperhomocysteinemia in Mexican adults
  19. Quantitative detection of target cells using unghosted cells (UGCs) of DxH 800 (Beckman Coulter)
  20. Evaluation of different sized blood sampling tubes for thromboelastometry, platelet function, and platelet count
  21. Cancer Diagnostics
  22. Routine use of the Ion Torrent AmpliSeq™ Cancer Hotspot Panel for identification of clinically actionable somatic mutations
  23. Analytical performance of a new one-step quantitative prostate-specific antigen assay, the FREND™ PSA Plus
  24. Relationship between prostate-specific antigen kinetics and detection rate of radiolabelled choline PET/CT in restaging prostate cancer patients: a meta-analysis
  25. Methylation of OPCML promoter in ovarian cancer tissues predicts poor patient survival
  26. Cardiovascular Diseases
  27. Red blood cell distribution width predicts survival in patients with Eisenmenger syndrome
  28. Low serum adropin is associated with coronary atherosclerosis in type 2 diabetic and non-diabetic patients
  29. Corrigendum
  30. Standardization and analytical goals for glycated hemoglobin measurement
  31. Letter to the Editors
  32. Do we need to worry about contamination by circulating fetal DNA?
  33. Stat testing utilization in clinical laboratories. National survey of Italian Society of Clinical Biochemistry and Molecular Biology (SIBioC)
  34. Aldosterone measurement with LiaisonXL automated system: remarks about reference range
  35. Better blood collection tubes for plasma glucose: ready for prime time?
  36. Upregulation of cytokines and IL-17 in patients with hereditary angioedema
  37. Underestimation of platelet count on magnesium salt-anticoagulated samples
  38. Extensive elevation of BNP but not NT-ProBNP in a patient with advanced urothelial carcinoma in absence of cardiac failure and volume overload
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