Description

Product Overview

The CA15‑3 Test Kit is a fluorescence immunoassay designed for quantitative determination of CA15‑3 tumor marker levels. CA15‑3 is commonly associated with breast cancer and is useful in disease monitoring, prognosis evaluation and therapeutic response assessment.

Intended Use

For in vitro quantitative determination of CA15‑3 in human serum or plasma as an aid in diagnosis and monitoring of breast cancer.

Clinical Significance

Supports breast cancer monitoring, evaluates treatment response, assists prognosis assessment and helps detect recurrence or metastasis.

Test Principle

Sandwich fluorescence immunoassay using labelled monoclonal antibodies forming antigen‑antibody complexes measured quantitatively by analyzer.

Sample Type

Serum / Plasma

Sample Volume

100 µL

Test Time

Approximately 10 minutes

Measuring Range

1.5 – 300 U/mL

Detection Limit

≤1.5 U/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, breast cancer monitoring, hospital laboratories, diagnostic centers and research laboratories.