Description

Product Overview

The tPSA Test Kit is a fluorescence immunoassay designed for quantitative determination of total prostate specific antigen levels. PSA is an important biomarker used in screening, diagnosis and monitoring of prostate cancer and other prostate related disorders.

Intended Use

For in vitro quantitative determination of total PSA in serum or plasma as an aid in diagnosis and management of prostate cancer.

Clinical Significance

Supports prostate cancer screening, evaluates treatment response, assists disease monitoring and helps detect recurrence.

Test Principle

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

Sample Type

Serum / Plasma

Sample Volume

100 µL

Test Time

Approximately 15 minutes

Measuring Range

0.40 – 100.00 ng/mL

Detection Limit

≤0.40 ng/mL

Expected Reference Value

≤4.0 ng/mL

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, hospital laboratories, diagnostic centers and preventive health screening programs.