Practical Evaluation of Methods for Detection and Specificity of Autoantibodies to Extractable Nuclear Antigens
Open accessAbstract
Detection and specificity of autoantibodies against extractable nuclear antigens (ENA) play a critical role in the diagnosis and management of autoimmune disease. Historically, the detection of these antibodies has employed double immunodiffusion (DID). Autoantibody specificity was correlated with diagnoses by this technique. Enzyme immunoassays have been developed by multiple manufacturers to detect and identify the specificity ENA autoantibodies. To address the relationship of ENA detection by DID and enzyme immunoassay, the performances of five immunoassays were compared. These included two DID and three enzyme-linked immunoassays (ELISA) (both screening and individual antigen profile kits). The sample set included 83 ENA-positive, antinuclear-antibody (ANA)-positive specimens, 77 ENA-negative, ANA-positive specimens, and 20 ENA- and ANA-negative specimens. Sensitivity and specificity were calculated by two methods: first, by using the in-house DID result as the reference standard, and second, by using latent class analysis, which evaluates each kit result independently. Overall, the results showed that the ELISA methods were more sensitive for detection of ENA autoantibodies than DID techniques, but presence and/or specific type of ENA autoantibody did not always correlate with the patient's clinical presentation. Regardless of the testing strategy an individual laboratory uses, clear communication with the clinical staff regarding the significance of a positive result is imperative. The laboratory and the clinician must both be aware of the sensitivity and specificity of each testing method in use in the clinical laboratory.
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Latent class analysis is robust to violations of the conditional independence assumption.
“While LCA assumes test independence, it is robust to violations of this assumption [24].”
From Diagnosis of placental malaria in poorly fixed and processed placental tissue (2016) · cites this paper as [24]
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- Authors
- Orton, S. M., Peace-Brewer, A., Schmitz, J. L., Freeman, K., Miller, W. C., & Folds, J. D.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- Corresponding author
- Orton, Susan M.
- Venue
- Clinical and Vaccine Immunology
- Publisher
- American Society for Microbiology
- Published
- 2004-03
- Volume
- 11
- Issue
- 2
- Pages
- 297-301
- ISSN
- 1556-679X (ISSN-L)
- 1556-6811
- PMC
- PMC371197
- OpenAlex
- W2165333706
- Cited by
- 35
- References
- 28
- Citations by year
- 2026: 1 · 2022: 2 · 2020: 2 · 2019: 1 · 2018: 2 · 2017: 1 · 2016: 2 · 2015: 3 · 2014: 2 · 2013: 2 · 2012: 3
- FWCI
- 1.35
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Locations
- Clinical and Vaccine Immunology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Pathology and Forensic Medicine › Systemic Sclerosis and Related Diseases
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Vasculitis and related conditions
- Keywords
- extractable nuclear antigens, autoantibody detection, double immunodiffusion, enzyme-linked immunoassay, assay sensitivity and specificity, latent class analysis, antinuclear antibodies, autoimmune disease diagnosis, assay comparison
- MeSH terms
- Antibody Specificity, Epitopes, Autoantibodies, Autoimmune Diseases, Enzyme-Linked Immunosorbent Assay, Humans, Reagent Kits, Diagnostic, Sensitivity and Specificity, Antigens, Nuclear
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