This company has received 510(k) clearance from the FDA to market its Anti-Endomysial (AEmA) Test kit. The kit is for the qualitative and semi-quantitative detection of IgA- class endomysial antibodies.
These antibodies are present in 60 to 70 percent of patients with Dermatitis herpetiformis (DH) on a non-restricted diet and in close to 100 percent of patients with Celiac disease (CD) and gluten-sensitivity enteropathy with partial or subtotaling villous atrophy.
In a number of CD patients, the symptoms and anti-endomysial antibody titers decline once patients are put on a gluten-free diet. Thus, the detection of these antibodies can be used for diagnosis of CD and for monitoring of the disease process.
Anti-endomysial antibodies, exhibiting some organ and species specificity, can be detected by indirect immunofluorescence. Patient samples are incubated with sections of primate esophagus tissue. The antibody, if present, will bind to the endomysium, a connective tissue sheath located between the smooth muscle fibers of the muscularis layer of the esophagus tissue.
A positive reaction, when viewed under a fluorescent microscope, appears as an apple green fluoresce staining of the endomysium or reticulin components of the smooth muscle filaments of the esophagus substrate.
The kits are available in either a 48- or 96-test size. Included in the test kits are four-well or eight-well substrate slides, liquid reagents (controls, conjugate and mounting medium) pretitered at ready-to-use dilutions. Kits also can be custom assembled according to customer specifications. MeDiCa
