Multicenter study to compare the diagnostic performance of CLIA vs. FEIA transglutaminase IgA assays for the diagnosis of celiac disease

被引:12
作者
Castelijn, Daan A. R. [1 ,2 ]
Mulder, A. H. Leontine [3 ,4 ]
van der Pol, Pieter [5 ]
Hollander, Jolien C. [1 ,2 ]
Kuiper, Tietie [3 ]
Bijnens, Caroline [6 ]
Damoiseaux, Jan [6 ]
Bontkes, Hetty J. [1 ,2 ]
机构
[1] Amsterdam UMC, Dept Clin Chem, Lab Med Immunol, Locat VUMC, Amsterdam, Netherlands
[2] Amsterdam Inst Infect & Immun, Amsterdam Gastroenterol Endocrinol Metab, Amsterdam, Netherlands
[3] Medlon BV, Clin Lab, Westerhaar, Netherlands
[4] Ziekenhuis Grp Twente, Dept Clin Chem, Hengelo, Netherlands
[5] Reinier Haga MDC, Dept Immunol, Med Labs, Delft, Netherlands
[6] Maastricht Univ, Cent Diagnost Lab, Med Ctr, Maastricht, Netherlands
关键词
celiac disease; diagnostic performance; serology; tissue transglutaminase; EUROPEAN-SOCIETY; VILLOUS ATROPHY; GUIDELINES; ANTIBODIES; ACCURACY; BIOPSY; ULN;
D O I
10.1515/cclm-2022-1045
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
Objectives: Celiac disease (CD) is an immune-mediated enteropathy driven by gluten intake. Presence of tTG-IgA antibodies is important for the diagnosis. However, different tTG-IgA assays are used and test performance may vary. Therefore, a retrospective multicenter study was performed to compare the diagnostic performance of three assays. Methods: The fluorescence enzyme-linked immunoassay (FEIA) EliA Celikey IgA (Phadia), the chemiluminescence immunoassays (CLIA) h-tTG IgA QUANTA Flash((R)) (Inova Diagnostics) and the anti-tTG ChLIA IgA (Euroimmun) were compared. Diagnostic samples from CD cases (95 adults; 65 children) and controls (479 adults; 253 children) were included. Samples were blinded and reanalyzed on all platforms. Results: A high quantitative correlation between platforms was found (p < 0.0001). Both CLIA were more sensitive (adults 100%; children 100%) compared to the FEIA (adults 88.4%; children 96.6%). Specificity of all assays was high (>= 97.6%) with the FEIA having the highest specificity. A cut-off based on receiver operator characteristic analysis (6.5 U/mL) improved the sensitivity of the FEIA (adults 95.8%; children 100%) without affecting specificity. Cut-off values for the CLIA assays did not need further optimization. With the FEIA, 71% of pediatric cases had a tTG-IgA level & GE;10x upper limit of normal compared to 91 and 92% with QUANTA Flash and ChLIA, respectively. Conclusions: All platforms have high diagnostic accuracy. The CLIA assays are more sensitive compared to the FEIA assay. A lower cut-off for the FEIA improves diagnostic performance, particularly in adult cases that, as demonstrated in this study, present with lower tTG-IgA levels compared to pediatric cases.
引用
收藏
页码:1446 / 1454
页数:9
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