Microarray Immunoassay Improves Accuracy and Speed of Celiac Disease Diagnosis

Celiac disease is a chronic autoimmune disorder affecting one in every hundred people globally, primarily impacting the small intestine and often presenting with a range of multiorgan symptoms. The disease is characterized by an inappropriate immune response to gluten in individuals who are genetically predisposed, which leads to autoantibody production and damage to the small bowel. The standard diagnostic process includes serological tests for specific autoantibodies, supplemented by other clinical, laboratory, imaging, genetic, and histopathological assessments. Now, a multiplexed microarray immunoassay designed to improve the accuracy and speed of diagnosing celiac disease can help better the lives of affected patients.

AliveDx’s (Eysins, Switzerland) multiplexed MosaiQ AiPlex CD microarray immunoassay provides a novel and efficient solution to streamline the diagnosis process and alleviate the unnecessary burden associated with celiac disease testing. Clinical guidelines suggest screening for IgA autoantibodies against tissue Transglutaminase (anti-tTG IgA) and Deamidated Gliadin Peptides (anti-DGP IgA). Considering the prevalence of selective IgA deficiency among some individuals with celiac disease, assessments of total IgA levels to accompany autoantibody tests are recommended. In instances of IgA deficiency, it is advised to check for pertinent IgG autoantibodies (e.g., anti-tTG IgG, anti-DPG IgG).

The MosaiQ AiPlex CD immunoassay incorporates the most clinically significant autoantibodies, namely tTG IgA, DGP IgA, tTG IgG, and DGP IgG, along with total IgA antibodies detection, offering comprehensive diagnostic insights from a single sample and blood draw. This facilitates laboratories in automating and simplifying the diagnostic process for celiac disease. Following a diagnosis, immediate adoption of a Gluten-Free Diet (GFD) is beneficial for patients, not only in alleviating gastrointestinal symptoms but also in preventing serious long-term health issues. AliveDx’s MosaiQ AiPlex CD microarray immunoassay has been awarded the IVDR-CE mark certification, confirming its safety, efficacy, and readiness for broad clinical application in regions accepting the CE mark.

"We are thrilled to obtain the CE mark for our MosaiQ AiPlex CD microarray," said Manuel O. Mendez, CEO of AliveDx. "The MosaiQ fast portfolio expansion marks our fourth microarray CE mark approval in the last 12 months reflecting our dedication to rapidly advance diagnostic technologies and our commitment to support the millions of individuals affected by autoimmune diseases. Early and accurate diagnosis is crucial for managing this condition. Our innovative MosaiQ microarray solutions represent a significant advancement to partner with laboratorians and clinicians to reduce healthcare costs and improve patient outcomes and quality of life."

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