Comparison of an enzyme immunoassay to an indirect fluorescent immunoassay for the detection of antinuclear antibodies.
The standard method for detecting antinuclear antibodies (ANAs) is by immunofluorescence assay (IFA), a method that is labor intensive and subjective. In an attempt to overcome these limitations, several commercial enzyme immunoassays (EIAs) have been developed. We report the results of our evaluation of the ANA Microplate EIA (Sanofi Diagnostics Pasteur, Chaska, MN). For the evaluation, 808 serum samples were tested by EIA and IFA; 52 specimens were positive by both assays, 561 were negative by both assays, 91 were positive by EIA only, and 3 were positive by IFA only. Borderline results (not positive or negative) were obtained for 101 specimens, which were excluded when calculating the sensitivity, specificity, and positive and negative predictive values of this assay, which were 94.6%, 86.0%, 36.4%, and 99.5%, respectively. Because of its high negative predictive value, this assay can be used reliably to detect ANA-negative samples; however, the low positive predictive value indicates that EIA-positive specimens should be retested by an IFA to determine the final result.
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Related Subject Headings
- Sensitivity and Specificity
- Reagent Kits, Diagnostic
- Pathology
- Lupus Erythematosus, Systemic
- Immunoenzyme Techniques
- Humans
- Fluorescent Antibody Technique, Indirect
- False Positive Reactions
- Connective Tissue Diseases
- Antibodies, Antinuclear
Citation
Published In
DOI
ISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- Sensitivity and Specificity
- Reagent Kits, Diagnostic
- Pathology
- Lupus Erythematosus, Systemic
- Immunoenzyme Techniques
- Humans
- Fluorescent Antibody Technique, Indirect
- False Positive Reactions
- Connective Tissue Diseases
- Antibodies, Antinuclear