Endomysium (Primate esophagus)

Primary DI

00845533002011

Brand

Endomysium (Primate esophagus)

Company

ZEUS SCIENTIFIC, INC.

Model

5396EL

Catalog number

5396EL

Device description

Indirect fluorescent assay (IFA) for anti-endomysial antibodies has proven to be a good method to screen for Celiac disease. Endomysial antibodies of the IgA subclass (IgA EmA) react with the reticulin component of the endomysium of the smooth muscle in primate esophagus tissue. These antibodies can be found in 60-70% of patients with Dermatitis herpetiformis (DH) on a non-restricted diet and in almost 100% of patients with Celiac disease (CD) and gluten-sensitivity enteropathy with partial or sub totaling villous atrophy. There is a small percentage of IgG EmA that will be negative IgA when screened. A negative result exhibited by a patient with overt clinical symptoms may need to be considered for IgG testing.It is recommended to perform an anti-Gliadin test in order to reach the maximum specificity of the test. It has been demonstrated that serum IgA endomysial antibodies were found in the majority (87%) of patients with untreated Celiac disease and approximately 70% of anti-Gliadin (IgA AGA) positive patients. The R1 anti-Reticulin (R1-ARA) appears to be a less reliable marker with less than 50% being positive. These findings were based on the same patient population. It should be noted that a strict adherence to a gluten-free diet will greatly effect the antibody results in most patients. IgA AGA and R1-ARA will normally disappear after one year while IgA EmA may persist at a lower titer. In this way the test may have prognostic value in monitoring strict adherence to diet.

Published

2025-10-17

Public version status

New

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true

Single use

true