Proinsulin Intact ELISA

Intended Use

The Human Intact Proinsulin ELISA is a sensitive ”two-site” sandwich enzyme-linked immunosorbent assay for the quantitative determination of intact Proinsulin in human plasma and serum.

Clinical Use

Proinsulin is produced in the pancreatic β-cells and is normally further processed to insulin and C-peptide. It is only seen in low concentrations in the plasma of healthy subjects. Insulin resistance (IR) or hyperglycemia causes increased insulin secretion and finally a secretion disorder. Intact proinsulin levels in plasma then increase while insulin levels decrease. Elevated fasting intact proinsulin is a specific biomarker for β-cell dysfunction and IR and independent risk factor for cardiovascular disease.

In clinical practice, fasting morning intact proinsulin can be used as highly specific indicator of clinically relevant insulin resistance and β-cell dysfunction, the underlying cause of type 2 diabetes. Levels can be used to serve as the basis for the selection of an insulin resistance therapy, and to monitor the therapeutic effect on ß-cell dysfunction. Patients with elevated fasting intact proinsulin levels should be regarded and treated as insulin resistant and possibly prediabetic, in order to reduce the risk for further cardiovascular damage.

When used during the oral glucose tolerance test, the 2-hour intact proinsulin levels are highly predictive of future development of type 2 diabetes, even before glucose, HbA1c and insulin changes are detectable. In fact, 2-hour intact proinsulin test predicts type 2 diabetes up to 4 years before clinical manifestation.

Elevated fasting intact proinsulin levels may also be seen in patients with insulinoma, or prior to manifestation of type 1 diabetes.

Advantages of Proinsulin Intact ELISA:

• Early Detection:Intact Proinsulin indicates type 2 prediabetes before glucose changes. It predicts type 2 diabetes up to 4 years before clinical diagnosis.
• Insight into Insulin Resistance: Elevated intact proinsulin levels offer valuable information on insulin resistance, contributing to a comprehensive understanding of metabolic health.
• Diagnostic Accuracy: The ELISA kit distinguishes itself by measuring intact proinsulin with high specificity, avoiding potential confounding factors present in total proinsulin assays.
• Clinical Utility: Widely employed in reputable research and clinical studies1; 2, Proinsulin Intact ELISA is recognized for its clinical relevance and reliability.

Test performance:

• Trusted Results: Calibrated with the latest WHO Standard 09/296
• Precision matters proven performance in external ring trial (published by INSTAND)
• Ease of use: Test can be performed within 3 hours.

Distributed by TECAN, IBL International

For concrete data please consult the Instruction for Use in the download box on the top right side.