人抗胰島素IgG檢測 Human Anti Insulin IgG ELISA Kit 說明書

人抗胰島素IgG檢測試劑盒

Human Anti Insulin IgG ELISA Kit

cat#3600-HIG

INTENDED USE

ADI’s Anti-Insulin ELISA Test Kit has been designed for the quantitative determination of

Autoantibodies to Human Insulin in serum and plasma. The assay is useful for the

determination of Type I Diabetes, as well as for screening purposes to detect developing

insulin autoantibodies in monkey under insulin therapy.

INTRODUCTION

Type I Diabetes is mainly characterized by limited or fully missing secretion of the hormone

insulin. Morphological studies demonstrated a destruction of the beta cells of the so-called

Langerhanns's Cells (Islet Cells) in Type I diabetics. Numerous researchers described the

appearance of antibodies directed against the islet cells and insulin as the causal reason

for the onset of the disease. Anti-Insulin antibodies are found in 37 percent of patients with

newly detected Type I Diabetes, in 4% of their relatives of the first degree and in up to

1.5% of healthy controls. A positive correlation between the appearance of anti-Insulin and

anti-Islet Cell antibodies has been reported. Anti-Insulin autoantibodies may be detected

several months and in some cases years before the onset of the fully clinical manifestation

of the diseases. Occasionally also autoantibodies to Pro-Insulin may appear. These ''true''

anti-Insulin autoantibodies directed against endogenous insulin have to be distinguished

from those autoantibodies which are developed in insulin dependent diabetics undergoing

therapy with insulin preparations of animal origin. In fact the latter have to be referred to

side effects. These side effects may occur as local reactions of the skin by development of

insulin-specific autoantibodies. These autoantibodies are causing the formation of an

insulin depot and they may simulate a resistance against the hormonal treatment with

animal insulin. 

SPECIFICITY and Animal Crossreactivity

The microplate is coated with highly purified preparations of recombinant human insulin.

The conjugate used in the kit is against the human IgG, therefore, only IgG-subclass

antibodies will be detected. This kit will not detect anti-insulin IgG in other species. ADI

has separate anti-insulin ELISA kits for monkey, mouse and rat samples.

Standard Unit Calibration

No international reference preparation for human anti-Insulin autoantibodies is available,

the assay system is calibrated in relative arbitrary units.

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Toxicol. Pathol. 29, 142-148; Reeves, W.G. et al (1983) Diabetologia, 24, 399; Atkinson,

M.A., (1985) Diabetes 34, 926-930; Willein, T. (1985) Diabetes 76, 185; Kobayashi,

N.(1985) J. Immunol. Methods 84; 245. Wissllein, T (1985) Lancet 1, 480; Soeldner, J.S.

(1985) NEJM 313, 893.