MDI Gliadin IgG Test (96 test kit)

MDI Gliadin IgG Test

Gliadin is found in gluten of wheat and rye grains. An anti-gliadin antibody activates the onset of celiac disease (CD), a gastrointestinal disorder characterized by flattening of the jejunal mucosa. In patients with celiac disease, the destruction of gut mucosa increases the permeability to macromolecules. Celiac disease is a relatively common disorder and affects about one in two hundred adult individuals. High-risk groups for CD include, IgA deficient individuals, patients with Down's syndrome, first-degree relatives of CD patients and adults with insulin-dependent diabetes mellitus .

Gliadin is a mixture of several components with molecular weight of 16-40 kDa. In patients with CD, detection of IgG antibodies to gliadin is more useful than IgA, however, IgA antibody is more specific than IgG. The titer of anti- gliadin IgG and IgA rise significantly during gluten challenge. In patients with a gluten-free diet, the titer of IgA antibodies decreases significantly.

EIA is the accepted standard assay for detection of IgA and IgG antibodies to gliadin. The MDI Gliadin G Test and MDI Gliadin A Test are EIA techniques, which are used for both semi-quantitative and qualitative measurements of IgG and IgA antibodies against Gliadin.

Summary of 510(k)

MDI Gliadin G Test reagents (P/N: GLKi-A) are intended for the qualitative and semi-quantitative determination of IgG antibodies to gliadin in human serum. The principal diagnostic value of this test is detection of anti-gliadin IgG, which is used as an aid in patients with Celiac Disease.

The Micro Detect, Inc. Gliadin IgG assay reagents (MDI Gliadin IgG Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigen, Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution.

The performance of MDI Gliadin G Test was determined using patient specimens. The assay results were compared with the results obtained using predicate assay. A correlation study was conducted on 199 patient specimens from both genders (51% male and 49% female), different races and various ages (26% from 1-17 years and 74% from 17-78 years old subjects). Of the 199 specimens tested 95 were negative and 104 were positive for the presence of IgG antibodies to Gliadin. The performance of MDI Gliadin IgG Test is shown in the following table:

In addition, one hundred twenty random serum samples obtained from a clinical lab were also tested on MDI Gliadin IgG Test for the presence of IgG antibodies to Gliadin. Random specimens were also from both genders, different races and various ages( few months to 99 years old).

The patient results obtained using the MDI Gliadin G Test is substantially equivalent to those obtained by using predicate assays:

Relative Sensitivity: 100%

Relative Specificity: 99%

Overall Agreement: 99.5%

Precision (%CV): 1.68 - 5.6(Inter) and 1.4 - 6.9(Intra)

Stability: One year at 2-8 C. The stability of the MDI Gliadin G Test Kit for the detection of IgG antibodies to gliadin was found to be one year at 2-8 C. This was predicted from studies done under stress condition (37 C).

No cross reactivity with H. pylori, ds-DNA, Rheumatoid Factor and various ENAs was detected on MDI Gliadin IgG Test.

The Micro plate ELISA formats is a commonly used format for the detection of many entities of clinical interest, including Celiac Disease.

The MDI Gliadin G Test system is shown to provide results, which are substantially equivalent to those obtained by a predicate product.