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CLIA C-peptide

The chemiluminescence assay is intended for use as an aid in diagnosis of disorders of insulin production, including diabetes mellitus, by determining the presence and quantity of C-peptide in human serum and EDTA plasma in the general population presenting with symptoms typical of disorders of insulin production. The quantitative automated assay is designed for professional use in a laboratory.

New
Catalog Number: CL-CPT050
Size: 50 tests
Regulatory status: CE IVD
Clinical topic: Diabetes & Metabolism Disorders
Diagnostic panel: Diabetes
Producer: TestLine Clinical Diagnostics s.r.o.
CLIA C-peptide

C-peptide is formed during the conversion of proinsulin to insulin and is released in equimolar amounts together with endogenous insulin. It is an important marker of endogenous insulin production and provides valuable information about the functional status of pancreatic beta cells.

Unlike insulin itself, C-peptide is not influenced by exogenous insulin administration and therefore allows a more accurate assessment of endogenous insulin secretion. It is considered one of the most valuable markers of residual pancreatic function and can help determine whether a patient still retains the ability to produce insulin.

C-peptide testing is useful for the differential diagnosis of type 1 and type 2 diabetes, monitoring the progressive decline of beta-cell function and evaluating the overall metabolic status of the patient throughout the course of the disease.

The portfolio of markers for functional pancreatic assessment, C-peptide and Insulin, complemented by autoimmune diabetes markers GAD65 and IA-2, which are not commonly available on other CLIA platforms, represents a significant advantage of the CLIA solution from BioVendor Group.

Benefits of BioVendor Group's Diabetes Panel on the CLIA Platform

  • The combination of functional and autoimmune markers enables more precise differentiation of type 1 diabetes, LADA, and type 2 diabetes
  • Supports early diagnosis of autoimmune diabetes, including in patients with an atypical disease course or unclear classification
  • Increases clinical value in situations where standard classification is insufficient and contributes to a better understanding of disease etiology
  • Streamlines the testing process and simplifies the interpretation of results
  • GAD65 and IA-2 markers in CLIA format on a fully automated platform ensure a high level of automation and maximum user convenience

Technical specifications

Technical data
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Technical data

Assay time30 min
Assay stability30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
Sample matrix Serum, Plasma
Sample volume20 µL
Measuring range0–10 000 pmol/l
Assay/kit contentReagent Cartridge with specific reagents for the assay, magnetic beads, calibrators
Complementary productsAnchorĀ® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
Note

The kits are CE-IVD certified and intended for professional use.

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Safety information

Declaration of conformity

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