Type
Sandwich ELISA
Description
The TECO® 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.
Applications
Serum, Plasma
Sample Requirements
50 µl/well
Shipping
On blue ice packs. Upon receipt, store the product at the temperature recommended below.
Storage/Expiration
Store the complete kit at 2–8°C. Under these conditions, the kit is stable until the expiration date (see label on the box).
Calibration Range
0–145.3 pmol/l
Limit of Detection
0.15 pmol/l
Intra-assay (Within-Run)
CV ≤ 2.2%
Inter-assay (Run-to-Run)
CV ≤ 4%
Note
The kits are CE-IVD certified and intended for professional use.
Features
- European Union: for in vitro diagnostic use
- rest of the world: RUO
- the kit measures total intact proinsulin in serum and plasma
- limit of detection 0.15 pmol/l
- components of the kit are in the lyophilized, concentrated and ready to use states
- this test is standardized against the International Standard for Intact Proinsulin (WHO 09/296)
Research topic
Diabetology - Insulin, C-Peptide, Proinsulin
Summary
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.
Instructions for Use (RUO)
Instructions for Use (RUO)
Safety Information (RUO)
MSDS (RUO)
MSDS (RUO)
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