Intended Use:

AESKUCARE® Gluten-Related Disorders IgA is a nearpatient (point of care) in-vitro immunoassay intended for the qualitative and quantitative simultaneous measurement of human-specific IgA antibodies against tTG, tTG neo, mTG, mTG neo, DGP, gliadin, Frazer’s fraction, TG3, and total IgA in heparinized or Na-EDTA venous or capillary whole blood, plasma, or serum. sIgA concentrations can be determined quantitatively by using a separately available reader or qualitatively by the naked eye.

It is intended for use as a point of care tool to support the diagnosis of patients presenting with various clinical symptoms associated with gluten-related disorders. It is to be carried out by healthcare professionals experienced in the use of in vitro diagnostic methods.

Coated Antigens:

mTG neo (test row 2)
Microbial transglutaminase (neo-epitopes)

TG3 (test row 2)
Transglutaminase 3 (human epidermal transglutaminase)

tTG (test row 2)
Human tissue transglutaminase

tTG neo (test row 2)
Human tissue transglutaminase (neo-epitopes)

mTG (test row 3)
Microbial transglutaminase

Frazer`s F (test row 3)
Frazer´s fraction

Gliadin (test row 3)
Alpha-gliadin

DGP (test row 3)
Deamidated gliadin-specific peptide

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