Description

Product Overview

The fPSA Test Kit is a fluorescence immunoassay designed for quantitative determination of free prostate specific antigen levels. Measurement of free PSA in combination with total PSA improves clinical specificity in differentiating benign prostatic hyperplasia from prostate cancer and supports patient risk stratification.

Intended Use

For in vitro quantitative determination of free PSA in serum or plasma as an aid in diagnosis and monitoring of prostate diseases.

Clinical Significance

Supports prostate cancer risk evaluation, improves diagnostic specificity, assists disease monitoring and helps guide biopsy decisions.

Test Principle

Sandwich fluorescence immunoassay where labelled monoclonal antibodies bind free PSA antigen forming complexes measured quantitatively by analyzer.

Sample Type

Serum / Plasma

Sample Volume

100 µL

Test Time

10 minutes

Measuring Range

0.03 – 30.00 ng/mL

Detection Limit

≤0.03 ng/mL

Expected Reference Value

Approximately 1.0 ng/mL (population distribution reference)

Technology

Fluorescence Immunoassay

Compatible Analyzers

GETEIN 1100
GETEIN 1160

Storage & Stability

Store at 4–30°C with shelf life up to 24 months.

Applications

Oncology diagnostics, prostate cancer screening support, hospital laboratories, diagnostic centers and preventive health screening programs.