Description

Product Overview

The HbA1c Test Kit is a fluorescence immunoassay designed for quantitative measurement of HbA1c levels. HbA1c reflects the average blood glucose concentration over the previous 2–3 months and plays a crucial role in diabetes diagnosis, monitoring and therapeutic management.

Intended Use

For in vitro quantitative determination of HbA1c in human whole blood as an aid in monitoring long‑term blood glucose control in diabetic patients.

Clinical Significance

Supports diagnosis of diabetes mellitus, evaluation of glycemic control, risk assessment of diabetic complications and monitoring of treatment effectiveness.

Test Principle

Fluorescence immunoassay based on anti‑human HbA1c monoclonal antibodies forming immune complexes detected quantitatively by the analyzer.

Sample Type

Whole Blood

Test Time

Approximately 5 minutes

Measuring Range

2.0% – 14.0%

Detection Limit

≤2.0%

Technology

Fluorescence Immunoassay

Compatible Analyzers

GETEIN 1100
GETEIN 1160

Storage & Stability

Store at 4–30°C until expiry date.

Applications

Diabetology clinics, hospital laboratories, diagnostic centers, preventive health screening programs and point‑of‑care testing setups.