Description

Product Overview

The C-Peptide Test Kit is a sandwich fluorescence immunoassay designed for quantitative determination of circulating C-Peptide levels. C-Peptide is released in equimolar amounts with insulin and serves as an important marker for endogenous insulin secretion.

Intended Use

For in vitro quantitative determination of C-Peptide in human serum and plasma as an aid in diagnosis and treatment of patients with abnormal insulin secretion.

Clinical Significance

Supports evaluation of pancreatic beta-cell function, differentiation of endogenous and exogenous insulin secretion, diabetes mellitus assessment and monitoring of insulin therapy.

Test Principle

The assay uses sandwich fluorescence immunoassay technology where fluorescence-labelled anti-C-Peptide antibodies form immune complexes with C-Peptide in the sample and are quantitatively detected by the analyzer.

Sample Type

Serum / Plasma

Test Time

Approximately 15 minutes

Measuring Range

0.05 – 30.00 ng/mL

Detection Limit

≤0.05 ng/mL

Precision

Within-run Precision ≤10%
Between-lot Precision ≤15%

Expected Reference Range

1.10 – 4.40 ng/mL

Technology

Fluorescence Immunoassay (Sandwich Method)

Compatible Analyzers

GETEIN 1100
GETEIN 1160

Storage & Stability

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

Applications

Diabetology clinics, endocrinology laboratories, hospital diagnostic departments and metabolic disorder screening centres.

Key Advantages

• Quantitative endogenous insulin secretion assessment
• Supports pancreatic beta-cell evaluation
• Helps differentiate insulin source
• Rapid analyzer-based testing
• High sensitivity fluorescence immunoassay