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AliveDx Expands Autoimmune Testing Capability with MosaiQ AiPlex CTDplus

Recent Developments in Autoimmune Diagnostics

Recently, AliveDx announced that it has received IVDR-CE certification for its innovative diagnostic tool, the MosaiQ AiPlex CTDplus multiplex assay. This state-of-the-art test aims to streamline laboratory workflows and enhance the diagnosis of systemic rheumatic autoimmune diseases, which present a significant challenge in terms of diagnosis.

Understanding Systemic Rheumatic Autoimmune Diseases

Systemic rheumatic autoimmune diseases, including rheumatoid arthritis (RA), systemic lupus erythematosus, systemic sclerosis (scleroderma), Sjögren's syndrome, and others, affect millions worldwide. These diseases are associated with the production of autoantibodies and often share overlapping clinical symptoms, making accurate diagnosis quite complex. Due to the nature of these conditions, delays in diagnosis can occur, which can have serious implications on patient health. The ability to identify various autoantibodies can aid clinicians substantially in evaluating and diagnosing these diseases effectively. Here, multiplex testing comes into play, providing a comprehensive autoantibody profile that can significantly shorten the time to diagnosis.

Features of MosaiQ AiPlex CTDplus

The MosaiQ AiPlex CTDplus assay enables healthcare providers to adopt a syndrome-based approach, facilitating accurate serological evaluations of conditions like RA and connective tissue diseases (CTD). It uniquely combines multiple autoantibody tests into one sensitive and specific solution, delivering actionable insights for improved patient care. This test requires only 10 μl of patient serum obtained in a single step, making it not only quick but efficient.

The CTD microarray utilized in the test includes 15 key markers in a single panel, thereby aligning with leading clinical guidelines recommended by the American College of Rheumatology and European Alliance of Associations for Rheumatology (ACR/EULAR). Tests for autoantibodies such as CCP, dsDNA, and others are included in the panel, contributing to a robust diagnostic process.

According to Manuel O. Méndez, CEO of AliveDx, this recent achievement marks the fifth time in the last 18 months that they have received clinical IVDR approvals. "This milestone is a testament to our dedication to improving patient care. Prompt and accurate diagnoses are critical in managing complex autoimmune disorders, and our MosaiQ AiPlex CTDplus assay significantly aids laboratory staff and clinicians in achieving this goal," he stated.

Innovations in Diagnostic Workflow

The MosaiQ System introduces an innovative, fully automated microarray platform that allows for syndromic testing for complex disease diagnoses. This advanced system not only meets high throughput demands with rapid testing but also assures continuous random access, yielding swift and accurate results aligned with modern laboratory efficiency expectations. In fact, this can report on up to 1,275 disease markers per hour for the MosaiQ AiPlex CTDplus solution.

Additionally, the system features built-in calibration and quality control processes alongside multi-component external quality checks to facilitate straightforward laboratory workflows. All reagents and multiplex microarray kits are tagged with RFID for efficiency, reducing manual errors and enhancing overall laboratory productivity.

AliveDx's Commitment

AliveDx is committed to leveraging over 30 years of experience to drive innovation in in-vitro diagnostics, particularly within autoimmune diseases and allergies. Their mission focuses on producing diagnostic insights to enhance patient care while fostering a progressive and sustainable working environment for healthcare providers. With a promising future ahead, AliveDx is also planning to expand its offering to include multiplex solutions for vasculitis and antiphospholipid antibodies, further advancing the diagnosis of systemic autoimmune diseases.

For more insights on AliveDx and their diagnostic solutions, visit their website at Alivedx.com.