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Human Intact Proinsulin ELISA

  • Regulatory status:RUO
  • Type:Sandwich ELISA
  • Species:Human
Cat. No. Size Price

TE1012 96 wells (1 kit)
PubMed Product Details
Technical Data


Sandwich ELISA


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.


Serum, Plasma

Sample Requirements

50 µl/well


On blue ice packs. Upon receipt, store the product at the temperature recommended below.


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%


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



  • 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


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.

Summary References (10)

References to Proinsulin

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  • Haffner SM, Bowsher RR, Mykkanen L, Hazuda HP, Mitchell BD, Valdez RA, Gingerich R, Monterossa A, Stern MP. Proinsulin and specific insulin concentration in high- and low-risk populations for NIDDM. Diabetes. 1994 Dec;43 (12):1490-3
  • Hanley AJ, D'Agostino R Jr, Wagenknecht LE, Saad MF, Savage PJ, Bergman R, Haffner SM. Increased proinsulin levels and decreased acute insulin response independently predict the incidence of type 2 diabetes in the insulin resistance atherosclerosis study. Diabetes. 2002 Apr;51 (4):1263-70
  • Houssa P, Dinesen B, Deberg M, Frank BH, Van Schravendijk C, Sodoyez-Goffaux F, Sodoyez JC. First direct assay for intact human proinsulin. Clin Chem. 1998 Jul;44 (7):1514-9
  • Kitabchi AE. Proinsulin and C-peptide: a review. Metabolism. 1977 May;26 (5):547-87
  • Klee GG. Human anti-mouse antibodies. Arch Pathol Lab Med. 2000 Jun;124 (6):921-3
  • Kricka LJ. Human anti-animal antibody interferences in immunological assays. Clin Chem. 1999 Jul;45 (7):942-56
  • Linde S, Roder ME, Hartling SG, Binder C, Welinder BS. Separation and quantitation of serum proinsulin and proinsulin intermediates in humans. J Chromatogr. 1991 Jul 12;548 (1-2):371-80
  • Robbins DC, Tager HS, Rubenstein AH. Biologic and clinical importance of proinsulin. N Engl J Med. 1984 May 3;310 (18):1165-75
  • Stiles AD, D'Ercole AJ. The insulin-like growth factors and the lung. Am J Respir Cell Mol Biol. 1990 Aug;3 (2):93-100
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