Comparative evaluation of serologic tests for celiac disease: a European initiative toward standardization.


Autoria(s): Stern, M.; Andersson, C.; Bürgin-Wolff, Annemarie; Grodzinsky, E.; Kapitza, S.; Laurila, K.; Ludtke, R.; Mäki, Markku; Mascart, Françoise; Neunhoeffer, E.; Ocmant, Annick; Savilahti, E.; Volta, Umberto; Wascher, I.; Wruk, M.; Zalewski, T.
Data(s)

01/11/2000

Resumo

BACKGROUND: Serologic methods have been used widely to test for celiac disease and have gained importance in diagnostic definition and in new epidemiologic findings. However, there is no standardization, and there are no reference protocols and materials. METHODS: The European working group on Serological Screening for Celiac Disease has defined robust noncommercial test protocols for immunoglobulin (Ig)G and IgA gliadin antibodies and for IgA autoantibodies against endomysium and tissue transglutaminase. Standard curves were linear in the decisive range, and intra-assay variation coefficients were less than 5% to 10%. Calibration was performed with a group reference serum. Joint cutoff limits were used. Seven laboratories took part in the final collaborative study on 252 randomized sera classified by histology (103 pediatric and adult patients with active celiac disease, 89 disease control subjects, and 60 blood donors). RESULTS: IgA autoantibodies against endomysium and tissue transglutaminase rendered superior sensitivity (90% and 93%, respectively) and specificity (99% and 95%, respectively) over IgA and IgG gliadin antibodies. Tissue transglutaminase antibody testing showed superior receiver operating characteristic performance compared with gliadin antibodies. The K values for interlaboratory reproducibility showed superiority for IgA endomysium (0.93) in comparison with tissue transglutaminase antibodies (0.83) and gliadin antibodies (0.82 for IgG, 0.62 for IgA). CONCLUSIONS: Basic criteria of standardization and quality assessment must be fulfilled by any given test protocol proposed for serologic investigation of celiac disease. The working group has produced robust test protocols and reference materials available for standardization to further improve reliability of serologic testing for celiac disease.

Comparative Study

Evaluation Studies

Journal Article

info:eu-repo/semantics/published

Formato

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Identificador

uri/info:pmid/11144436

http://hdl.handle.net/2013/ULB-DIPOT:oai:dipot.ulb.ac.be:2013/51147

Idioma(s)

en

Fonte

Journal of pediatric gastroenterology and nutrition, 31 (5

Palavras-Chave #Sciences bio-médicales et agricoles #Adolescent #Adult #Celiac Disease -- blood #Celiac Disease -- diagnosis #Child #Enzyme-Linked Immunosorbent Assay #Fluorescent Antibody Technique #Humans #Immunoglobulin A -- blood #Immunoglobulin G -- blood #Quality Control #ROC Curve #Reference Standards #Reference Values #Reproducibility of Results #Sensitivity and Specificity #Serologic Tests -- standards
Tipo

info:eu-repo/semantics/article

info:ulb-repo/semantics/articlePeerReview

info:ulb-repo/semantics/openurl/article