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ANALYTICAL COMPARISON OF A NOVEL, FULLY AUTOMATED MULTIPLEXED MICROARRAY IMMUNOASSAY AND ROUTINE METHODS FOR THE DETECTION OF CELIAC DISEASE ANTIBODIES IN A LABORATORY IN ENGLAND

Faye Sims 1, Gerber Gomez 2, Christian Fischer 2

Affiliations

1 Peterborough City Hospital, North West Anglia NHS Foundation Trust, Peterborough, United Kingdom

2 AliveDx, Eysins, Switzerland

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Abstract

Introduction

Detection of autoantibodies directed to tissue transglutaminase (tTG) and deamidated gliadin peptide (DGP) is important in the assessment of individuals under clinical suspicion of celiac disease (CD).

Aims & Methods

In this study, we compared the analytical performance for the detection of autoantibodies to tTG (IgA isotype), of the MosaiQ AiPlex^® CD microarray (AiPlex CD. AliveDx, Switzerland), a CE-marked, novel, single-use, fully automated, multiplexed microarray immunoassay and routine methods. De-identified serum samples, characterized as reactive or non-reactive for tTG IgA as per the routine practice method of the evaluation site (EliA™ Celikey^® IgA, Phadia AB, Sweden), were tested with the evaluated device. Although AiPlex CD features the semi-quantitative measurement of both tTG IgA and IgG and anti-deamidated gliadin peptide (DGP) IgA and IgG antibodies, and qualitative measurement of total IgA in serum; this comparison was limited to tTG IgA as no samples characterized for other CD autoantibodies were available. Positive percent agreement (PPA) and negative percent agreement (NPA) were calculated. Double-sided 95% Confidence Intervals (CI) were calculated using Clopper-Pearson Exact Method.

Results

77 samples characterized as reactive for tTG IgA by the routine method and 90 samples characterized as non-reactive for this marker were included in the analysis. The evaluated device identified 73 out of 77 samples characterized as reactive by the routine method, for a PPA of 95% (95% CI: 87.2, 98.5). Out of the four discordant samples, one also yielded a non-reactive result for tTG IgG and reactive results for both DGP IgA and IgG in the evaluated device and negative anti-endomysial antibodies (EMA) by immunofluorescence; two samples were reactive to DGP IgA or DGP IgG by the evaluated device and one sample was non-reactive to all four markers and was negative to EMA. Regarding the samples characterized as non-reactive by the routine method, the evaluated device identified 86 out of 90, for an NPA of 96% (95% CI: 89.0, 98.7). For the four samples with discordant results, the evaluated device also yielded reactive results for at least one additional CD antibody (tTG IgG, DGP IgA, DGP IgG).

Table 1. Agreement of the investigational microarray immunoassay with the comparator method
tTG: tissue transglutaminase. PPA: positive percent agreement; NPA: negative percent agreement. CI: Confidence interval.
Parameter / Measurand	tTG IgA
Reactive results (n)	77
PPA	95%
95% CI	87.2, 98.5
Non-reactive results	90
NPA	96%
95% CI	89.0, 98.7

Conclusion

In this study, the evaluated microarray immunoassay showed high concordance with the compared routine method for the serological assessment of tTG IgA, a key marker in the evaluation of CD.

Disclosure

This study was funded by AliveDx Suisse SA, Eysins, Switzerland. Gerber Gomez and Christian Fischer are AliveDx employees.

Conference

UEG Week Berlin 2025

Topics

Small Intestine & Nutrition

Submission format

Abstract

Session

SMALL INTESTINAL (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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GAPS IN DISEASE-SPECIFIC KNOWLEDGE IN INFLAMMATORY BOWEL DISEASE PATIENTS AT A TERTIARY CARE CENTER

Louisa Stechel 1, Thu Giang Le Thi 2, Leandra Koletzko 1, Ralph Wimmer 1, Benjamin Misselwitz 1, Sibylle Koletzko 2, Noortje GM Rossen 3, Helga Török 1

Affiliations

1 LMU University Hospital, Ludwig-Maximilians University, Munich, Munich, Germany

2 Dr. von Hauner Children's Hospital, LMU University Hospital of Munich, Munich, Germany

3 Amsterdam University Medical Centre, Amsterdam, Netherlands

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

Disease-specific knowledge plays a central role in chronic disease management. In patients with inflammatory bowel disease (IBD), limited knowledge is linked to poorer perceived health and increased discomfort (1).

Aims & Methods

This study assessed disease-specific knowledge among adult patients with IBD at a tertiary center and defined existing knowledge gaps. Factors associated with higher or lower levels of knowledge were explored.
The retrospective cohort study included 392 IBD patients who completed a comprehensive questionnaire between March 2020 and April 2021 (2). Questionnaire responses were analyzed alongside clinical records to quantify disease-specific knowledge. A scoring system was developed to quantify disease-specific knowledge (0–8 points), based on correct diagnosis, Montreal classification, complications, and current therapies. Scores were categorized as low (0–5) or high (6–8) knowledge levels. Associations between knowledge levels and disease-related, sociodemographic, and psychosocial factors were analyzed using logistic regression analysis.

Results

While most patients correctly identified their diagnosis (kappa: 0.863, CI: 0.816–0.905, p < 0.001) and advanced treatment (e.g. infliximab: kappa: 0.959, CI: 0.925–0.983, p < 0.001), knowledge gaps were observed regarding disease location (e.g. isolated proctitis in ulcerative colitis: kappa: 0.101, CI: –0.051–0.341, p = 0.128), complications, comorbidities, and certain other medications. In the univariate analysis a higher knowledge level was found in patients with Crohn’s disease, younger age at diagnosis, in patients with no disease activity, and treatment with biologics, in those receiving disability pension and in patients with a high Perceived Stress Questionnaire (PSQ) score for worries (table). A younger age at diagnosis (p = 0.028) and having Crohn’s disease (p < 0.001) were independently associated with higher knowledge levels whereas active disease was associated with lower disease-specific knowledge.
Table:
Univariate logistic regression analysis for items significantly associated with higher knowledge levels

Items (reference variable/dummy variable)	Overall knowledge level, OR (95% CI), p value
Diagnosis (CD/UC)	0.243 (0.133-0.445), p<0.001
Age at diagnosis	0.969 (0.950-0.989), p=0.002
Physician global assessment (no activity/moderate activity)	0.125 (0.047-0.333), p<0.001
Self-assessment (no activity/moderate activity)	0.269 (0.125-0.579), p<0.001
Treatment includes any biologics (no/yes)	2.381 (1.331-4.259), p=0.003
PSQ-Score worries	1.013(1.004-1.022), p=0.008
Receiving disability pension (no/ yes)	0.088 (0.020-0.382), p=0.001

Conclusion

Significant disease-specific knowledge gaps were identified, particularly concerning disease location, complications, and comorbidities. Targeted patient education should focus on addressing these specific deficits in susceptible groups.

References

Tormey LK, Reich J, Chen YS, Singh A, Lipkin-Moore Z, Yu A, et al. Limited Health Literacy Is Associated With Worse Patient-Reported Outcomes in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2019;25:204–12.
Koletzko L, Klucker E, Le Thi TG, Breiteneicher S, Rubio-Acero R, Neuhaus L, et al. Following Pediatric and Adult IBD Patients through the COVID-19 Pandemic: Changes in Psychosocial Burden and Perception of Infection Risk and Harm over Time. J Clin Med. 2021;10:4124.

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Eduardo Redondo-Cerezo

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Daniel A. Leffler

Regions	Age (yr)
	2+1	6+1	10+1	Out of range	In range	Total	Planned	%Planned
Campania	468	536	498	224	1502	1726	1739	86,37
Lombardy	824	936	1050	186	2810	2996	2867	98,01
Marche	113	123	127	19	363	382	394	92,13
Sardinia	96	126	147	61	369	430	363	101,65
Total	1501	1721	1822	490	5044	5534	5363

Neutrophil localisation	Cut-off (cells/mm2)		Sensitivity (%)		Specificity (%)		Accuracy (%)
Assessment of disease activity
Epithelium	10.1		90 (83-96)		75 (56-94)		85 (78-91)
Lamina propria	30.4		93 (87-98)		72 (55-90)		85 (79-91)
Total	21.7		94 (88-99)		74 (54-89)		86 (79-92)
Prediction of response to therapy - Histological Remission
	W12	W52	W12	W52	W12	W52	W12	W52
Epithelium	10.9	10.4	73 (41-94)	75 (52-95)	82 (67-95)	90 (77-100)	78 (64-90)	81 (67-94)
Lamina propria	33	27.9	72 (41-95)	74 (50-95)	84 (67-96)	89 (71-100)	78 (65-89)	80 (67-91)
Total	26.8	20.8	74 (47-95)	74 (48-94)	84 (70-96)	93 (80-100)	79 (66-91)	82 (68-94)

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