Anti-transglutaminase IgA antibody measurement in coeliac disease: Method comparison IDS-iSYS vs. Thermo Fisher Phadia.
Scand J Clin Lab Invest
; 80(7): 552-555, 2020 Nov.
Article
em En
| MEDLINE
| ID: mdl-32844702
ABSTRACT
In coeliac disease, the diagnostic work-up is based on a combination of clinical, histopathological and serological evaluation. Among the serological tests, the presence of tissue transglutaminase (tTG) IgA antibodies is the cornerstone owed to a high sensitivity and specificity. Recently, Immunodiagnostic Systems Ltd (IDS) introduced the fully automated chemiluminescent autoimmune assays for use on the IDS-iSYS Multi-Discipline Automated System. In this study, we aimed to compare the performance of the IDS-iSYS assay to the Thermo Fisher Phadia assay and to establish the upper reference limit of tTG IgA in a healthy population from Denmark based on the IDS-iSYS assay. We discovered a total imprecision of CV = 12.2% (2.87 AU/mL) and CV = 10.6% (47.55 AU/mL). Moreover, we compared the performance of IDS-iSYS assay to Thermo Fisher Phadia assay in 236 samples from unselected patients submit for tTG IgA testing and found a concordance of 97% (p < .0001). Furthermore, in 150 healthy blood donors, we established the upper reference limit of 3.26 AU/mL (95% CI 3.10 - 3.90) was identified. Our study validates the performance of the IDS-iSYS tTG IgA assay and demonstrates results in concordance with the established Thermo Fisher Phadia. Furthermore, it provides estimates for the upper reference interval limit of the tTG-IgA.
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Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Imunoglobulina A
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Doença Celíaca
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Transglutaminases
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Scand J Clin Lab Invest
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Dinamarca