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Analytical and Clinical Comparison of Two Fully Automated Immunoassay Systems for the Diagnosis of Celiac Disease
Joint Authors
Lakos, Gabriella
Norman, Gary L.
Martis, Peter
Santora, Debby
Bentow, C.
Fasano, Alessio
Mahler, Michael
Source
Journal of Immunology Research
Issue
Vol. 2014, Issue 2014 (31 Dec. 2014), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2014-03-13
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
Objective.
Here we compared analytical and clinical performance characteristics of two novel automated assay systems for the detection of celiac disease (CD) specific antibodies: QUANTA Flash (INOVA Diagnostics, Inc.) and EliA (Thermo Scientific).
Methods.
A total of 74 biopsy-proven CD patients (2 with IgA deficiency) and 138 controls were tested by both methods.
Results.
Sensitivities of QUANTA Flash assays ranged from 35.1% to 90.5% and specificities from 96.4% to 99.3%, while sensitivities for EliA assays ranged from 37.8% to 90.5% (equivocal considered positive) and specificities from 97.1% to 100.0%.
Good qualitative agreement was found between all assays.
Thirty-four (50.0%) of the 68 QUANTA Flash h-tTG IgA positive results were higher than 10 times the upper limit of normal (ULN).
In contrast, only 22.8% of the EliA tTG IgA positive samples were >10x ULN.
Seventy-three (98.6%) biopsy-proven CD patients were correctly identified with the QUANTA Flash h-tTG IgA+DGP IgG combination, while 64 (86.5%) and 72 (97.3%) (depending on equivocal range) were identified with the same combination of EliA assays.
Conclusion.
The QUANTA Flash CD assays have outstanding clinical performance.
Of particular clinical significance, in light of proposals to decrease the absolute necessity of biopsy, was the demonstration that 50% of the QUANTA Flash h-tTG IgA results were >10x ULN.
American Psychological Association (APA)
Lakos, Gabriella& Norman, Gary L.& Mahler, Michael& Martis, Peter& Bentow, C.& Santora, Debby…[et al.]. 2014. Analytical and Clinical Comparison of Two Fully Automated Immunoassay Systems for the Diagnosis of Celiac Disease. Journal of Immunology Research،Vol. 2014, no. 2014, pp.1-9.
https://search.emarefa.net/detail/BIM-1040853
Modern Language Association (MLA)
Lakos, Gabriella…[et al.]. Analytical and Clinical Comparison of Two Fully Automated Immunoassay Systems for the Diagnosis of Celiac Disease. Journal of Immunology Research No. 2014 (2014), pp.1-9.
https://search.emarefa.net/detail/BIM-1040853
American Medical Association (AMA)
Lakos, Gabriella& Norman, Gary L.& Mahler, Michael& Martis, Peter& Bentow, C.& Santora, Debby…[et al.]. Analytical and Clinical Comparison of Two Fully Automated Immunoassay Systems for the Diagnosis of Celiac Disease. Journal of Immunology Research. 2014. Vol. 2014, no. 2014, pp.1-9.
https://search.emarefa.net/detail/BIM-1040853
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1040853