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Systematic Differences Between Total and Free Prostate-Specific Antigen Immunoassays: Comparison Using Passing and

Nafija Serdarevic¹, Pradeep Dabla², Adina Elena Stanciu³

¹Institute for Clinical Chemistry and Biochemistry, University of Sarajevo Clinics Center, 71000 Sarajevo, Bosnia and Herzegovina.

Indian Journal of Clinical Biochemistry : IJCB

|April 19, 2021

Summary

Differences in prostate-specific antigen (PSA) immunoassays exist between major diagnostic platforms. Harmonizing total PSA (tPSA) and free PSA (fPSA) measurements is crucial for accurate prostate cancer diagnosis.

Keywords:

Free PSA Immunoassay Method comparison Quality control Total PSA

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Area of Science:

Clinical Chemistry
Immunoassay Technology
Prostate Cancer Diagnostics

Background:

Systematic differences exist among various prostate-specific antigen (PSA) immunoassays.
Accurate measurement of total PSA (tPSA) and free PSA (fPSA) is critical for prostate cancer diagnosis and management.
Inter-method variability can impact clinical decisions, including the need for prostate biopsy.

Purpose of the Study:

To compare intermethod differences in tPSA and fPSA measurements between ARCHITECT i2000SR (Abbott) and COBAS E601 (Roche) platforms.
To evaluate the correlation and bias for tPSA, fPSA, and the percentage of fPSA (%fPSA) using Passing-Bablok regression analysis.
To determine if observed differences exceed clinically significant thresholds.

Main Methods:

Analysis of 160 blood samples for tPSA and 50 samples for fPSA (tPSA range: 4.1-10.0 μg/L).
Utilized ARCHITECT i2000SR and COBAS E601 diagnostic platforms for immunoassays.
Employed Passing-Bablok regression for comparative analysis of tPSA, fPSA, and %fPSA.

Main Results:

Strong correlations (r=0.94-0.99) observed between the two platforms for tPSA, fPSA, and %fPSA.
COBAS E601 yielded higher tPSA (bias: 0.8 μg/L) and fPSA (bias: 0.14 μg/L) concentrations compared to ARCHITECT i2000SR.
COBAS E601 exceeded a 10% relative difference limit for fPSA and %fPSA compared to ARCHITECT i2000SR.

Conclusions:

Significant intermethod differences in tPSA and fPSA measurements exist between Abbott and Roche platforms.
These discrepancies can affect diagnostic accuracy and clinical decision-making for prostate cancer.
Harmonization of PSA immunoassays is essential to ensure consistent and reliable patient results.