Clinical chemistry autoimmune IVDs

Intended purpose

The MosaiQ® AiPlex CD is composed of single-use immunoassay microarrays to be used in conjunction with the automated MosaiQ 125 instrument and the associated MosaiQ reagents. It is intended for the in vitro semi-quantitative measurement of both IgA and IgG Anti-tissue Transglutaminase (anti-tTG) and IgA and IgG Anti-Deamidated Gliadin Peptide (anti-DGP) antibodies, as well as a qualitative measurement of the Total IgA antibodies in human serum. The Total IgA measurement is intended for use in the interpretation of the IgA and IgG anti-tTG and anti-DGP antibody results. The product is intended for professional use within a clinical laboratory environment and is useful as an aid in the clinical diagnosis of patients with celiac disease. It is to be used in conjunction with other laboratory and clinical findings.