Lab Med Qual Assur.  2019 Dec;41(4):207-213. 10.15263/jlmqa.2019.41.4.207.

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

• Choi WK
• Kim HK
• Lee W
• Chun S
• Min WK

• KMID: 2470321
• DOI: http://doi.org/10.15263/jlmqa.2019.41.4.207

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.

Keyword

Prostate Health Index; Prostate-specific antigen; Free prostate-specific antigen; [-2]Pro-prostate-specific antigen

MeSH Terms

Chungcheongnam-do
Limit of Detection
Prostate*
Prostate-Specific Antigen
Prostatic Neoplasms
Prostate-Specific Antigen