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 performan...
| Publicado en: | Archives of Pathology & Laboratory Medicine Vol. 148; no. 12; pp. 1422 - 1431 |
|---|---|
| Autores principales: | , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
College of American Pathologists
Dec2024
|
| 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=181184764&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 181184764 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00039985 1FS jtl: Archives of Pathology & Laboratory Medicine issn: 00039985 maglogo: N pubinfo: dt: Dec2024 vid: 148 iid: 12 pid: 2550 pub: College of American Pathologists place: Northfield, Illinois artinfo: ui: 181184764 181184764 181184764 10.5858/arpa.2022-0385-OA 181184764 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 Human United Kingdom Male Female Immunoglobulins Sensitivity and Specificity Protein Glutamine gamma Glutamyltransferase 2 Blood Autoantibodies Blood 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 |
|---|