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pISSN 2384-2458 eISSN 2288-7261
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Original Article

J Lab Med Qual Assur 2019; 41(4): 207-213

Published online December 31, 2019

https://doi.org/10.15263/jlmqa.2019.41.4.207

Copyright © Korean Association of External Quality Assessment Service.

Performance Evaluation of the Total ProstateSpecific Antigen (PSA), Free PSA, and [–2]proPSA Assay for Calculation of the Prostate Health Index Using the UniCel DxI 800 Analyzer

Won-Kyu Choi, Hyun-Ki Kim, Woochang Lee, Sail Chun, and Won-Ki Min

Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Correspondence to:Woochang Lee
Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea
Tel: +82-2-3010-4516 Fax: +82-2-478-0884 E-mail: wlee1@amc.seoul.kr

Received: October 14, 2019; Revised: November 4, 2019; Accepted: November 14, 2019

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background:

Prostate-specific antigen (PSA) is widely used as a tumor marker of prostate cancer, but it is not specific for cancer. Numerous efforts have been made to find another tumor marker that can replace PSA. Recently, the Prostate Health Index (PHI) has been introduced, which shows higher diagnostic performance for prostate cancer than PSA. In this study, we evaluated the performance of the UniCel DxI 800 (Beckman Coulter, USA) for quantitative measurement of total PSA (tPSA), free PSA (fPSA), and [-2]proPSA used for calculating the PHI.

Methods:

The precision, linearity, and limit of detection of the three items, as well as the correlation between the UniCel DxI 800 (Beckman, USA) and a comparable instrument in the Asan Medical Center, the Alinity i (Abbott, USA), were evaluated in accordance with the Clinical Laboratory Standards Institute guidelines.

Results:

The total coefficient of variation for the three items was less than 5%. Linearity was observed for each manufacturer-claimed analytical measurement range, with R2=0.99. The claimed limit of blank and limit of detection were verified. The results of the UniCel DxI 800 showed good correlation with those of the Alinity i (tPSA, r=0.995; fPSA, r=0.994).

Conclusions:

The UniCel DxI 800 showed good analytical performance. Therefore, it will be useful to use the UniCel DxI 800 in the clinical laboratory to measure the diagnostic markers of prostate cancer.

Keywords: Prostate Health Index, Prostate-specific antigen, Free prostate-specific antigen, [-2]Pro-prostate-specific antigen

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