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Other Diagnostics · C-peptide CLIA
TestLine Distributed by Goffin Diagnostics

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.

CLIA CE-IVD TestLine 1 Package (50 Tests)
Technique
CLIA
Brand
TestLine
Packaging
1 Package (50 Tests)
Diagnostic Panel
Diabetes
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Quote-based, no public pricing. Add to your quote and our specialists put together a proposal with the right documentation, typically within 24 hours.

Product details

This kit in detail

  • 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

Description

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

Technical data

  • Assay time: 30 min
  • Assay stability: 30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
  • Sample matrix: Serum, Plasma
  • Sample volume: 20 μL
  • Measuring range: 0–10 000 pmol/l
  • Complementary products: Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
  • Note: The kits are CE-IVD certified and intended for professional use.

Specifications

  • 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.

References

  • Wahren J, Ekberg K, Johansson J, Henriksson M, Pramanik A, Johansson BL, Rigler R, Jörnvall H. Role of C-peptide in human physiology. Am J Physiol Endocrinol Metab. 2000 May;278(5):E759-68. doi: 10.1152/ajpendo.2000.278.5.E759. PMID: 10780930.
  • Jones AG, Hattersley AT. The clinical utility of C-peptide measurement in the care of patients with diabetes. Diabet Med. 2013 Jul;30(7):803-17. doi: 10.1111/dme.12159. PMID: 23413806; PMCID: PMC3748788.
  • Cha T, Tahara Y, Ikegami H, Fukuda M, Yoneda H, Yamato E, Yamamoto Y, Noma Y, Shima K, Ogihara T. Urinary C-peptide as an index of unstable glycemic control in insulin-dependent diabetes mellitus (IDDM). Diabetes Res Clin Pract. 1991 Sep;13(3):181-7. doi: 10.1016/0168-8227(91)90062-i. Erratum in: Diabetes Res Clin Pract 1991 Nov;14(2):149. PMID: 1959481.
  • Wasada T, Kuroki H, Arii H, Maruyama A, Katsumori K, Aoki K, Saito S, Omori Y. Hyperglycemia facilitates urinary excretion of C-peptide by increasing glomerular filtration rate in non-insulin-dependent diabetes mellitus. Metabolism. 1995 Sep;44(9):1194-8. doi: 10.1016/0026-0495(95)90015-2. PMID: 7666795.
  • Reagent Cartridge with specific reagents for the assay
  • magnetic beads
  • calibrators
Documentation

Datasheets and regulatory documentation

Everything your quality team needs for evaluation and procurement.

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