Key Takeaways
What makes connective tissue diseases complex?
Autoimmune connective tissue diseases (CTDs) are systemic autoimmune disorders affecting joints, muscles and vital organs. CTDs often present with overlapping symptoms, making clinical diagnosis challenging. Globally, autoimmune rheumatic diseases impact over 4% of the population [1][2] with conditions like systemic lupus erythematosus and Sjögren’s syndrome contributing to significant morbidity. Early detection is important for improving patient outcomes and autoantibody profiling may assist clinicians in successful diagnosis.
Autoimmune disease panel and CTDs state complexity
There are several types of connective tissue diseases (CTDs), these include: SLE, Sjögren’s syndrome, systemic sclerosis, idiopathic inflammatory myopathies and mixed connective tissue disease. Conditions like rheumatoid arthritis share overlapping signs and symptoms which can complicate diagnosis. Autoantibodies are central to assessment, but single autoantibody workflows can be lengthy and fragmented. Multiplex approaches help clinicians evaluate several CTD associated markers within one structured panel [3].
Comorbidity challenges in autoimmune diagnostics
Patients with connective tissue diseases often experience overlapping autoimmune conditions, such as systemic lupus erythematosus coexisting with Sjögren’s syndrome or rheumatoid arthritis. These comorbidities amplify diagnostic complexity and increase the need for broad autoantibody profiling. Multiplex microarray testing addresses this challenge by enabling simultaneous detection of multiple markers in one automated run, supporting fast and accurate clinical decisions, even in labs with high throughput that can cause workflow and time challenges.
Why microarray autoimmune testing elevates clinical lab workflows
Microarray testing enables simultaneous marker detection of key autoantibodies in a single, automated step, delivering comprehensive serologic insight without the need for sequential assays. Our MosaiQ® solutions includes the IVDR-CE Marked AiPlex® CTDplus assay and covers up to 15 markers on one panel.
The MosaiQ AiPlex® CTDplus assay is composed of single-use immunoassay microarrays that are designed to be used in conjunction with a MosaiQ instrument that utilises automation and associated reagents. It is intended for the in vitro quantitative measurement of IgG antibodies directed to dsDNA, semi quantitative detection of IgG antibodies against various antigens including Extractable Nuclear. Antigens (ENA): TRIM21 (SS-A52), SS-A 60, SS-B, Sm, Sm/RNP, U1RNP, Scl-70, Jo-1, Chromatin, CENP-B, Ribosomal P Protein, RNA Polymerase III, CCP2 and DFS70 in human serum.
The presence of the following autoantibodies, in conjunction with clinical finding and other laboratory test, is an aid in the diagnosis of patients with the following CTD’s:
1Data on file
Automation works to close staffing gaps
Clinical labs for autoimmune and allergy diseases are under pressure from rising volumes and limited staffing. Our MosaiQ solution includes sample to result automation with embedded QC and calibration, as well as RFID tagged reagents, reduces manual touchpoints and increases walkaway time. This helps laboratory clinician teams redeploy their expertise to higher value tasks while maintaining optimal turnaround times [6][7].
Workflow efficiency: fast and effective microarray testing
The MosaiQ AiPlex® CTDplus generates multiple insights from just 10 µL of sample; a single microarray test can produce up to 15 results and shares key reagents with other panels to streamline lab inventory. Ready to use onboard reagents and standardized master curves embedded via RFID support consistent operations and reduced hands-on time [6].
Serology results in clinical lab insights
Bringing multiplex microarrays and automation together shortens time to result and consolidates reporting. The MosaiQ AiPlex® CTDplus assay helps reduce repeat sampling and fragmented testing, enabling clinicians to interpret co-occurring autoantibodies in a unified context, supporting earlier, more confident decisions in complex autoimmune presentations [3].
To find out more about what AliveDx products and solutions can do to help transform your lab workflow and support patient care, get in touch with us today.
*Certain assays and intended uses for the MosaiQ® AiPlex assays are currently under development and are not yet cleared by the U.S. Food and Drug Administration. The MosaiQ instrument is IVDR-CE Marked and available in the U.S. as a class II 510(k) exempt device.
*The MosaiQ AiPlex® CTDplus panel is IVDR-CE marked but currently not available for use in the US and/or all global regions.
©2025 – AliveDx Suisse SA – AliveDx, AliveDx logo, MosaiQ, AiPlex and MosaiQ AiPlex are trademarks or registered trademarks of AliveDx group companies in various jurisdictions. Not all methods may be available in all territories. Subject to regulatory clearance in some territories.
References
1. SpringerLink chapter: Autoimmune Diseases: Recent Insights on Epidemiology, Pathogenesis, and Prevalence Rate
2. Gunjan Nautiyal, Isha Sharma, Parijat Pandey & Shiv Kant Sharma.
Autoimmune Diseases: Recent Insights on Epidemiology, Pathogenesis, and Prevalence Rate. In: Artificial Intelligence and Autoimmune Diseases, Studies in Computational Intelligence, vol 1133. Springer, Singapore, 2024.
3. Ma Y, Chen H, Lv W, et al. Global, regional and national burden of rheumatoid arthritis from 1990 to 2021, with projections of incidence to 2050: a systematic and comprehensive analysis of the Global Burden of Disease study 2021. Biomarker Research. 2025.
4. MosaiQ AiPlex® CTDplus Brochure. AliveDx Suisse SA. 2025.
5. Nardella G, Gomez G, Fischer C, Monat C. Analytical Performance of a Fully Automated Multiplexed Microarray Immunoassay for the Simultaneous Detection of Fifteen Autoantibodies Associated with Connective Tissue Diseases in a Reference Laboratory in Southern France. Arthritis Rheumatol. 2025;77(suppl 9).
6. Gomez G, Cheng Y, Nita K, Hausmann M, Fischer C, Ataman-Önal Y. A Machine Learning Algorithm Based on a 15-Autoantibody Profile by a Novel Fully Automated Multiplexed Microarray Immunoassay for the Diagnosis of Autoimmune Connective Tissue Diseases. Arthritis Rheumatol. 2025;77(suppl 9).
7. MosaiQ AiPlex® CTDplus Workflow Details. AliveDx Suisse SA. 2025.
8. Poster: Machine Learning Algorithm CTDplus MosaiQ. ADLM Annual Scientific Meeting. 2025.
9. AliveDx Insights Center
10. Lerner A, Jeremias P, Matthias T. The World Incidence and Prevalence of Autoimmune Diseases is Increasing. Int J Celiac Dis. 2015;3(4):151-155.
