Application Research of Immunoassay in Clinical Diagnosis of Autoimmune Diseases
DOI:
https://doi.org/10.71222/3fc26z83Keywords:
immunoassay, autoimmune diseases, autoantibodies, clinical diagnosis, combined detectionAbstract
Autoimmune diseases present significant clinical challenges due to their complex pathogenesis and diverse manifestations, making early and accurate diagnosis crucial for effective patient management. This study aimed to comprehensively examine the impact and diagnostic utility of various immunoassays in the clinical evaluation of autoimmune diseases. A total of 128 patients suspected of having autoimmune disorders, admitted to a tertiary hospital between January 2022 and December 2024, were enrolled as the observation group. Concurrently, 64 healthy individuals undergoing routine physical examinations were selected as the control group. Both cohorts underwent extensive serological testing, including the detection of antinuclear antibodies (ANA), anti-double-stranded DNA (anti-dsDNA), anti-extractable nuclear antigens (anti-ENA), rheumatoid factor (RF), anti-cyclic citrullinated peptide (anti-CCP) antibodies, immunoglobulins, and complement components C3 and C4. The results demonstrated that the positivity rates of ANA, anti-dsDNA, anti-ENA, RF, and anti-CCP in the observation cohort were significantly higher than those in the control group (P < 0.05). Furthermore, the combined detection of these multiple immunological indicators yielded a remarkable diagnostic sensitivity of 92.19% and an overall accuracy of 90.10%, substantially outperforming single-item detection methods. In conclusion, comprehensive immunoassay profiling provides robust laboratory evidence for the effective screening, classification, and definitive diagnosis of autoimmune conditions. Implementing this multifaceted diagnostic tool can significantly accelerate detection speed, optimize clinical workflows, and substantially reduce the risk of missed or delayed diagnoses.References
1. G. E. Dinse, C. G. Parks, C. R. Weinberg, C. A. Co, J. Wilkerson, D. C. Zeldin, et al., "Increasing prevalence of antinuclear antibodies in the United States," Arthritis & Rheumatology (Hoboken, NJ), vol. 72, no. 6, p. 1026, 2020.
2. C. A. von Mühlen, I. Garcia-De La Torre, M. Infantino, J. Damoiseaux, L. E. Andrade, O. G. Carballo, et al., "How to report the antinuclear antibodies (anti-cell antibodies) test on HEp-2 cells: guidelines from the ICAP initiative," Immunologic Research, vol. 69, no. 6, pp. 594–608, 2021.
3. M. V. Sokolova, G. Schett, and U. Steffen, "Autoantibodies in rheumatoid arthritis: historical background and novel findings," Clinical Reviews in Allergy & Immunology, vol. 63, no. 2, pp. 138–151, 2022.
4. N. Bizzaro, D. Villalta, V. Bini, P. Migliorini, F. Franceschini, S. Piantoni, et al., "Multiparametric autoantibody analysis: a new paradigm for the diagnosis of connective tissue diseases," Arthritis Research & Therapy, vol. 24, no. 1, p. 278, 2022.
5. C. Bonroy, M. Vercammen, W. Fierz, L. E. Andrade, L. Van Hoovels, M. Infantino, et al., "Detection of antinuclear antibodies: recommendations from EFLM, EASI and ICAP," Clinical Chemistry and Laboratory Medicine (CCLM), vol. 61, no. 7, pp. 1167–1198, 2023.
6. G. Cafaro, E. Bartoloni, C. Baldini, F. Franceschini, V. Riccieri, A. Fioravanti, et al., "Autoantibody status according to multiparametric assay accurately estimates connective tissue disease classification and identifies clinically relevant disease clusters," RMD Open, vol. 9, no. 3, p. e003365, 2023.
7. M. Fenger, A. Wiik, M. Høier-Madsen, J. J. Lykkegaard, T. Rozenfeld, M. S. Hansen, et al., "Detection of antinuclear antibodies by solid-phase immunoassays and immunofluorescence analysis," Clinical Chemistry, vol. 50, no. 11, pp. 2141–2147, 2004.
8. M. Mahler, C. Bentow, J. Serra, and M. J. Fritzler, "Detection of autoantibodies using chemiluminescence technologies," Immunopharmacology and Immunotoxicology, vol. 38, no. 1, pp. 14–20, 2016.
9. A. Willitzki, R. Hiemann, V. Peters, U. Sack, P. Schierack, S. Rödiger, et al., "New platform technology for comprehensive serological diagnostics of autoimmune diseases," Journal of Immunology Research, vol. 2012, no. 1, p. 284740, 2012.
10. Y. Yao, L. Cao, X. Sun, Q. Wang, Z. Xu, T. Zhai, et al., "Laser‐Induced Periodic Phase‐Transition of 2D‐MoTe2 Nanograting Template for Frequency‐Shift Digital‐SERS Immunoassay of Autoimmune Disease," Advanced Science, p. e75366, 2026.
11. D. Chakraborty, M. Jain, A. Singh, P. S. Loomba, A. Sharma, and S. Tyagi, "Comparative evaluation of antinuclear antibody detection by indirect immunofluorescence and line immunoassay with clinical correlation in suspected autoimmune disease patients: a retrospective cross-sectional study," Clinical Rheumatology, pp. 1–11, 2026.
12. S. Sciascia, N. Bizzaro, P. L. Meroni, D. Borghi, M. O. Borghi, X. Bossuyt, et al., "Autoantibodies testing in autoimmunity: Diagnostic, prognostic and classification value," Autoimmunity Reviews, vol. 22, no. 7, p. 103356, 2023.
13. R. Tozzoli, F. D’Aurizio, D. Villalta, and L. Giovanella, "Evaluation of the first fully automated immunoassay method for the measurement of stimulating TSH receptor autoantibodies in Graves’ disease," Clinical Chemistry and Laboratory Medicine (CCLM), vol. 55, no. 1, pp. 58–64, 2017.
14. M. Plebani, M. Pittoni, M. Celadin, D. Bernardi, and M. M. Mion, "Recent advances in diagnostic technologies for autoimmune diseases," Autoimmunity Reviews, vol. 8, no. 3, pp. 238–243, 2009.
15. A. Kumar, A. Bansal, M. Mahto, B. Kumari, S. Kumar, A. Banerjee, et al., "The role of indirect immunofluorescence (IIF) and line immunoassay (LIA) in the diagnosis of autoimmune diseases and their clinical correlation: an observational study from a tertiary care center in Bihar," Cureus, vol. 15, no. 10, 2023.
16. A. Florea, G. Melinte, I. Simon, and C. Cristea, "Electrochemical biosensors as potential diagnostic devices for autoimmune diseases," Biosensors, vol. 9, no. 1, p. 38, 2019.
