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Other Diagnostics · Insulin CLIA
TestLine Distributed by Goffin Diagnostics

CLIA Insulin

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 insulin 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

Insulin is a key hormone responsible for regulating glucose metabolism. Its measurement provides important information about pancreatic secretion, insulin resistance, and the overall metabolic status of the patient.

Measurement of insulin levels is not routinely used for the primary diagnosis of diabetes. Its main benefit lies in the assessment of specific conditions, such as hyperinsulinemia, insulin resistance, suspected insulinoma, or unexplained hypoglycemia.

For a more comprehensive assessment of beta cell function and differential diagnosis of various forms of diabetes, insulin measurement can be beneficial in combination with C-peptide, which as a more reliable marker is not affected by the administration of exogenous insulin.

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: 0–346 mIU/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-INS050
  • Size: 50 tests
  • Regulatory status: CE IVD
  • Clinical topic: Diabetes & Metabolism Disorders
  • Diagnostic panel: Diabetes
  • Producer: TestLine Clinical Diagnostics s.r.o.

References

  • 11377828,10633871,11289468
  • Zhao WQ, Alkon DL. Role of insulin and insulin receptor in learning and memory. Mol Cell Endocrinol. 2001 May 25;177(1-2):125-34. doi: 10.1016/s0303-7207(01)00455-5. PMID: 11377828.
  • Chevenne D, Trivin F, Porquet D. Insulin assays and reference values. Diabetes Metab. 1999 Dec;25(6):459-76. PMID: 10633871.
  • McAuley KA, Williams SM, Mann JI, Walker RJ, Lewis-Barned NJ, Temple LA, Duncan AW. Diagnosing insulin resistance in the general population. Diabetes Care. 2001 Mar;24(3):460-4. doi: 10.2337/diacare.24.3.460. PMID: 11289468.
  • 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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