Abstract
Background:
AMiDot is a microdot array-based immunoassay that allows simultaneous detection of multiple autoantibodies on a single patient. We evaluated the AMiDot “Systemic Autoimmune Disease” (SAD) panel, which detects antibodies to 17 different antigens.
Methods:
AMiDot was performed on 184 samples from blood donors and on 280 randomly selected clinical samples containing antibodies to extractable nuclear antigens or to dsDNA. The results obtained by AMiDot on the clinical samples were compared to results obtained by EliA (Thermo Fisher) for anti-Ro60, anti-La, anti-RNP, anti-Scl-70, anti-CENPB, anti-Sm, and anti-Jo-1 and by Farr assay for anti-dsDNA. Discordant results were further analyzed by immunodot (D-tek).
Results:
Concordance between AMiDot and EliA was ≥87% and κ agreement ≥0.44. When compared to EliA and immunodot (in case of discordance between AMiDot and EliA), concordance improved to ≥91% and κ agreement to ≥0.77. The sensitivity of AMiDot (compared to EliA and immunodot, in case of discordance between AMiDot and EliA) was ≥93%, except for anti-Ro60 (84%). The concordance and κ agreement of AMiDot with the Farr assay (for dsDNA antibodies) was, respectively, 84% and 0.33. The sensitivity of AMiDot for dsDNA (compared to Farr assay) was 25%. The specificity was ≥97% (in blood donors as well as in clinical samples). The within-run imprecision was 9%–27% and the between-run imprecision 29%–39%.
Conclusions:
AMiDot offers an alternative to line immunodot assay. Individual antibody assays might suffer from low sensitivity.
Acknowledgments
We thank Keith Rawson for helpful discussions and Menarini for providing reagents and supporting the study.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: X.B. has received lecture fees from Menarini.
Employment or leadership: H.D. is employed by Menarini.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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©2017 Walter de Gruyter GmbH, Berlin/Boston
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- Frontmatter
- Editorial
- The central role of external quality assurance in harmonisation and standardisation for laboratory medicine
- Review
- Fecal calprotectin in inflammatory bowel diseases: update and perspectives
- Mini Review
- Factor VIIa-antithrombin complex: a possible new biomarker for activated coagulation
- Opinion Papers
- Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE)
- Metabolite profiling can change health-care delivery to obese patients with fatty liver disease: the search for biomarkers
- Genetics and Molecular Diagnostics
- Rapid screening for targeted genetic variants via high-resolution melting curve analysis
- Evaluation of the new cobas® HCV genotyping test based on real-time PCRs of three different HCV genome regions
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- Harmonisation of serum dihydrotestosterone analysis: establishment of an external quality assurance program
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- Prevalence of pseudonatremia in a clinical laboratory – role of the water content
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- Economic evaluation of procalcitonin-guided antibiotic therapy in acute respiratory infections: a Chinese hospital system perspective
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