Performance Assessment of a Novel Multianalyte Methodology for Celiac Disease Biomarker Detection and Evaluation of the Serology-Alone Criteria for Biopsy-Free Diagnosis.
Context.-- Serology plays a vital role in celiac disease (CD) diagnosis, and the latest European guidelines advocate for biopsy-free diagnoses in patients with ≥10x the upper limit of normal (ULN) of anti-tissue transglutaminase (tTG) immunoglobulin A (IgA) antibodies. Objective.-- To assess perform...
| Publicado en: | Archives of Pathology & Laboratory Medicine Vol. 147; no. 12; pp. 1422 - 1431 |
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| Autores principales: | , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
College of American Pathologists
Dec2023
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=174019681&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 174019681 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00039985 1FS jtl: Archives of Pathology & Laboratory Medicine issn: 00039985 maglogo: N pubinfo: dt: Dec2023 vid: 147 iid: 12 pid: 2550 pub: College of American Pathologists place: Northfield, Illinois artinfo: ui: 174019681 174019681 174019681 10.5858/arpa.2022-0385-OA 174019681 ppf: 1422 ppct: 9 formats: fmt: @attributes: type: P tig: atl: Performance Assessment of a Novel Multianalyte Methodology for Celiac Disease Biomarker Detection and Evaluation of the Serology-Alone Criteria for Biopsy-Free Diagnosis. aug: au: Novis, Camille Leite Wahl, Edward Camacho, Eric Aure, Mary Ann Mahler, Michael Nandakumar, Vijayalakshmi affil: ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, Utah sug: subj: Celiac Disease Diagnosis Biological Markers Blood Serologic Tests Methods Biopsy Methods Predictive Value of Tests Evaluation Sensitivity and Specificity Human ROC Curve Male Female United Kingdom Spearman's Rank Correlation Coefficient Descriptive Statistics Confidence Intervals Data Analysis Software Cluster Analysis McNemar's Test Male Female ab: Context.-- Serology plays a vital role in celiac disease (CD) diagnosis, and the latest European guidelines advocate for biopsy-free diagnoses in patients with ≥10x the upper limit of normal (ULN) of anti-tissue transglutaminase (tTG) immunoglobulin A (IgA) antibodies. Objective.-- To assess performance characteristics of a novel automated particle-based multianalyte technology (Aptiva) for anti-tTG and anti-deamidated gliadin peptide (DGP) antibody detection as compared to the traditional enzyme-linked immunosorbent assay (QUANTA Lite). Performance characteristics of the ≥10x ULN anti-tTG IgA criteria for serologic diagnosis of CD were also evaluated. Design.-- Sera samples from 703 patients were tested for anti-tTG IgA, anti-tTG immunoglobulin G (IgG), anti-DGP IgA, and anti-DGP IgG antibodies on both platforms. In total, 127 patients had medical information and were classified as CD-positive (n = 58) and CD-negative (n = 69) based on biopsy results. Clinical performance characteristics were evaluated. Results.-- Anti-tTG IgA detection showed equal clinical sensitivity and specificity of 91% sensitivity and 99% specificity on both platforms. Anti-tTG IgG resulted in moderate sensitivity of 69% and 72%, but high specificity of 100% and 94% on Aptiva and QUANTA Lite, respectively. Anti-DGP IgG displayed comparable sensitivity of 90% and 81%, and a specificity of 94% and 99%, on Aptiva and QUANTA Lite, respectively. Anti-DGP IgA demonstrated greater sensitivity on QUANTA Lite (83%) than Aptiva (69%) and similar specificities of 97% and 98% on QUANTA Lite and Aptiva, respectively. At ≥10x ULN levels for anti-tTG IgA, Aptiva displayed a sensitivity of 72% and a specificity of 100%, and QUANTA Lite showed a sensitivity of 69% and a specificity of 100%. Conclusions.-- Aptiva is a reliable method to measure CD biomarkers with reduced hands-on necessity and high-throughput capabilities. This study supports the use of a ≥10x ULN anti-tTG IgA biopsy-free approach for serologic diagnosis of CD. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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