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Clinical and Diagnostic Laboratory Immunology, March 2004, p. 297-301, Vol. 11, No. 2
1071-412X/04/$08.00+0     DOI: 10.1128/CDLI.11.2.297-301.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Practical Evaluation of Methods for Detection and Specificity of Autoantibodies to Extractable Nuclear Antigens

Susan M. Orton,^1* Amy Peace-Brewer,² John L. Schmitz,¹ Kristie Freeman,¹ William C. Miller,^3,4 and James D. Folds¹

McLendon Clinical Laboratories, University of North Carolina HealthCare,¹ Department of Medicine, University of North Carolina School of Medicine,³ Department of Epidemiology, University of North Carolina School of Public Health, Chapel Hill,⁴ Great Smoky Mountain Diagnostics, Asheville, North Carolina²

Received 19 June 2003/ Accepted 9 October 2003

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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* Corresponding author: Mailing address: McLendon Clinical Labs, University of North Carolina HealthCare, CB7525, 101 Manning Dr., Chapel Hill, NC 27514. Phone: (919) 966-6100. Fax: (919) 966-0486. E-mail: sorton{at}unch.unc.edu.

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Clinical and Diagnostic Laboratory Immunology, March 2004, p. 297-301, Vol. 11, No. 2
1071-412X/04/$08.00+0     DOI: 10.1128/CDLI.11.2.297-301.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

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