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Volta U, Caio G, De Giorgio R. Serology and screening in celiac disease. PEDIATRIC AND ADULT CELIAC DISEASE 2024:125-137. [DOI: 10.1016/b978-0-443-13359-6.00012-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/04/2025]
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Singh P, Arora A, Strand TA, Leffler DA, Mäki M, Kelly CP, Ahuja V, Makharia GK. Diagnostic Accuracy of Point of Care Tests for Diagnosing Celiac Disease: A Systematic Review and Meta-Analysis. J Clin Gastroenterol 2019; 53:535-542. [PMID: 29912751 DOI: 10.1097/mcg.0000000000001081] [Citation(s) in RCA: 27] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
GOALS To perform a systematic review and meta-analysis to estimate the overall diagnostic accuracy of point of care tests (POCTs) for diagnosing celiac disease (CD). BACKGROUND Recently, POCTs for CD have been developed and are commercially available. Studies have reported significant variability in their sensitivity (70% to 100%) and specificity (85% to 100%). STUDY We searched MEDLINE, EMBASE databases, and the Cochrane library through June 2017. Positive reference test was defined as villous atrophy along with positive celiac-specific serology and/or clinical improvement after gluten-free diet. Normal duodenal biopsy was defined as negative reference test. Bivariate random-effect model was used to present the summary estimates of sensitivities and specificities along with 95% confidence regions We assessed methodologic quality using the quality assessment of diagnostic accuracy studies-2 tool. RESULTS The pooled sensitivity and specificity of all POCTs (based on tTG or DGP or tTG+Anti-gliadin antibodies) for diagnosing CD were 94.0% [95% confidence interval (CI), 89.9-96.5] and 94.4% (95% CI, 90.9-96.5), respectively. The pooled positive and negative likelihood ratios for POCTs were 16.7 and 0.06, respectively. The pooled sensitivity and specificity for IgA-tTG-based POCTs were 90.5% (95% CI, 82.3-95.1) and 94.8% (95% CI, 92.5-96.4), respectively. CONCLUSIONS The pooled sensitivity and specificity of POCTs in diagnosing CD are high. POCTs may be used to screen for CD, especially in areas with limited access to laboratory-based testing. Further research assessing the diagnostic accuracy of individual POCTs and comparing it with other available POCTs is needed.
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Affiliation(s)
- Prashant Singh
- Division of Gastroenterology and Hepatology, Beth Israel Deaconess Medical Center, Boston
| | | | | | - Daniel A Leffler
- Division of Gastroenterology and Hepatology, Beth Israel Deaconess Medical Center, Boston
- Takeda Pharmaceuticals Inc, Cambridge, MA
| | - Markku Mäki
- Tampere Centre for Child Health Research, University of Tampere and Tampere University Hospital, Finland
| | - Ciaran P Kelly
- Division of Gastroenterology and Hepatology, Beth Israel Deaconess Medical Center, Boston
| | - Vineet Ahuja
- Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India
| | - Govind K Makharia
- Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India
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Tangermann P, Branchi F, Itzlinger A, Aschenbeck J, Schubert S, Maul J, Liceni T, Schröder A, Heller F, Spitz W, Möhler U, Graefe U, Radke M, Trenkel S, Schmitt M, Loddenkemper C, Preiß JC, Ullrich R, Daum S, Siegmund B, Bojarski C, Schumann M. Low Sensitivity of Simtomax Point of Care Test in Detection of Celiac Disease in a Prospective Multicenter Study. Clin Gastroenterol Hepatol 2019; 17:1780-1787.e5. [PMID: 30267867 DOI: 10.1016/j.cgh.2018.09.032] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/05/2018] [Revised: 08/28/2018] [Accepted: 09/13/2018] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS Point of care tests (POCTs) might be used to identify patients with undiagnosed celiac disease who require further evaluation. We performed a large multicenter study to determine the performance of a POCT for celiac disease and assessed celiac disease prevalence in endoscopy centers. METHODS We performed a prospective study of 1055 patients (888 adults; median age, 48 yrs and 167 children; median age, 10 yrs) referred to 8 endoscopy centers in Germany, for various indications, from January 2016 through June 2017. Patients were tested for celiac disease using Simtomax, which detects immunoglobulin (Ig)A and IgG antibodies against deamidated gliadin peptides (DGP). Results were compared with findings from histologic analyses of duodenal biopsies (reference standard). The primary aim was to determine the accuracy of this POCT for the detection of celiac disease, to identify candidates for duodenal biopsy. A secondary aim was to determine the prevalence of celiac disease in adult and pediatric populations referred for outpatient endoscopic evaluation. RESULTS The overall prevalence of celiac disease was 4.1%. The POCT identified individuals with celiac disease with 79% sensitivity (95% CI, 64%-89%) and 94% specificity (95% CI, 93%-96%). Positive and negative predictive values were 37% and 99%. When we analyzed the adult and pediatric populations separately, we found the test to identify adults with celiac disease (prevalence 1.2%) with 100% sensitivity and 95% specificity. In the pediatric population (celiac disease prevalence 19.6%), the test produced false-negative results for 9 cases; the test therefore identified children with celiac disease with 72% sensitivity (95% CI 53%-86%). Analyses of serologic data revealed significantly lower DGP titers in the false-negative vs the true-positive group. CONCLUSIONS In a study of more than 1000 adults and children, we found the Simtomax POCT to detect celiac disease with lower overall levels of sensitivity than expected. Although the test identifies adults with celiac disease with high levels of sensitivity and specificity, the prevalence of celiac disease was as low as 1.2% among adults. The test's lack of sensitivity might be due to the low intensity of the POCT bands and was associated with low serum DGP titers. Study ID no: DRKS00012499.
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Affiliation(s)
- Paul Tangermann
- Department of Gastroenterology, Infectious Diseases and Rheumatology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin and Berlin Institute of Health, Berlin, Germany
| | - Federica Branchi
- Department of Gastroenterology, Infectious Diseases and Rheumatology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin and Berlin Institute of Health, Berlin, Germany
| | - Alice Itzlinger
- Department of Gastroenterology, Infectious Diseases and Rheumatology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin and Berlin Institute of Health, Berlin, Germany
| | | | - Stefan Schubert
- Praxis für Gastroenterologie am Bayerischen Platz, Berlin, Germany
| | - Jochen Maul
- Praxis für Gastroenterologie am Bayerischen Platz, Berlin, Germany
| | - Thomas Liceni
- Praxis für Gastroenterologie am Bayerischen Platz, Berlin, Germany
| | | | | | | | | | | | | | | | - Markus Schmitt
- Evangelisches Krankenhaus Ludwigsfelde-Teltow, Ludwigsfelde, Germany
| | | | - Jan C Preiß
- Department of Gastroenterology, Infectious Diseases and Rheumatology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin and Berlin Institute of Health, Berlin, Germany
| | - Reiner Ullrich
- Department of Gastroenterology, Infectious Diseases and Rheumatology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin and Berlin Institute of Health, Berlin, Germany
| | - Severin Daum
- Department of Gastroenterology, Infectious Diseases and Rheumatology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin and Berlin Institute of Health, Berlin, Germany
| | - Britta Siegmund
- Department of Gastroenterology, Infectious Diseases and Rheumatology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin and Berlin Institute of Health, Berlin, Germany
| | - Christian Bojarski
- Department of Gastroenterology, Infectious Diseases and Rheumatology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin and Berlin Institute of Health, Berlin, Germany
| | - Michael Schumann
- Department of Gastroenterology, Infectious Diseases and Rheumatology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin and Berlin Institute of Health, Berlin, Germany.
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Mearns ES, Taylor A, Boulanger T, Craig KJ, Gerber M, Leffler DA, Drahos J, Sanders DS, Lebwohl B. Systematic Literature Review of the Economic Burden of Celiac Disease. PHARMACOECONOMICS 2019; 37:45-61. [PMID: 30221333 DOI: 10.1007/s40273-018-0707-5] [Citation(s) in RCA: 26] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/08/2023]
Abstract
BACKGROUND The prevalence of celiac disease (CD) has rapidly increased over recent decades, but costs related to CD remain poorly quantified. OBJECTIVE This systematic review assessed the economic burden of CD in North America and Europe. METHODS MEDLINE, EMBASE, EconLit, and the Cochrane Library databases were systematically searched to identify English-language literature from 2007 to 2018 that assessed costs, cost effectiveness, and health resource utilization for CD. RESULTS Forty-nine studies met the inclusion criteria, of which 28 (57.1%) addressed costs of testing and diagnosis; 33 (67.3%) were from Europe. The cost per positive CD diagnosis of testing patients already undergoing esophagogastroduodenoscopy for other indications ranged from 1300 Canadian dollars ($Can) in Canada (2016 value) to €44,712 in the Netherlands (2013 value). Adding the CD test was cost effective when it combined diagnostic modalities (e.g., serology and biopsy). Direct annual excess costs to a US payer per diagnosed CD patient totaled $US6000 (2013 value) more than for a person without CD, chiefly due to outpatient care. Hospitalizations, emergency visits, and medication use were more common with CD. After initiating a gluten-free diet (GFD), patients visited primary care providers less often, used more medications, and missed fewer days from school and work. CONCLUSIONS Most of the few available economic studies of CD assess testing and diagnosis costs, especially in Europe. Methods of testing generally are considered cost effective when they combine diagnostic modalities in symptomatic patients. Most costs to a payer of managing CD derive from outpatient care. Following GFD initiation, patients lose fewer days from work and school than pretreatment.
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Affiliation(s)
| | | | | | - Kelly J Craig
- Truven Health Analytics, An IBM Company, Cambridge, MA, USA
| | - Michele Gerber
- Takeda Pharmaceuticals International Co, Cambridge, MA, USA
| | | | | | - David S Sanders
- Royal Hallamshire Hospital and University of Sheffield, Sheffield, UK
| | - Benjamin Lebwohl
- Department of Medicine, Celiac Disease Center, Columbia University Medical Center, New York, NY, USA
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Abstract
GOALS To compare the diagnostic yield and cost-consequences of 2 strategies, screening regardless of symptoms versus case finding (CF), using a point-of-care test (POCT), for the detection of celiac disease (CD) in primary care, to bridge the diagnostic gap of CD in adults. MATERIALS AND METHODS All subjects under 75 years of age who consecutively went to their general practitioners' offices were offered POCT for anti-transglutaminase immunoglobulin A antibodies. The POCT was performed on all subjects who agreed, and then a systematic search for symptoms or conditions associated with higher risk for CD was performed, immediately after the test but before knowing the test results. The 2 resulting groups were: (a) POCT positive and (b) symptomatic subject at CF. Subjects were defined as symptomatic at CF in the presence of 1 or more symptoms. All POCT-positive or symptomatic subjects at CF were referred to the CD Centers for confirmation of CD. Data on resource consumption were gathered from patients' charts. Cost of examinations, and diagnostic and laboratory tests were estimated with regional outpatient tariffs (Sicily), and a price of &OV0556;2.5 was used for each POCT. RESULTS Of a total of 2197 subjects who agreed to participate in the study, 36 (1.6%) and 671 (30.5%) were POCT positive and symptomatic at CF, respectively. The yield from the screening and CF was 5 new celiac patients. The total cost and mean cost for each new CD case were &OV0556;7497.35 and &OV0556;1499.47 for the POCT screening strategy, and &OV0556;9855.14 and &OV0556;1971.03 for the CF strategy, respectively. Assuming consecutive use of both strategies, performing POCT only in symptomatic subjects at CF, the calculated yield would be 4 new diagnoses with a total cost of &OV0556;2345.84 and a mean cost of &OV0556;586.46 for each newly diagnosed patient. Only 1 patient was celiac despite a negative POCT. CONCLUSIONS Testing symptomatic subjects at CF only by POCT seems the most cost-effective strategy to bridge the diagnostic gap of adult CD in primary care.
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Office-Based Point of Care Testing (IgA/IgG-Deamidated Gliadin Peptide) for Celiac Disease. Am J Gastroenterol 2018; 113:1238-1246. [PMID: 29915400 DOI: 10.1038/s41395-018-0143-3] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/26/2018] [Accepted: 05/04/2018] [Indexed: 12/11/2022]
Abstract
OBJECTIVES Celiac disease (CD) is common yet under-detected. A point of care test (POCT) may improve CD detection. We aimed to assess the diagnostic performance of an IgA/IgG-deamidated gliadin peptide (DGP)-based POCT for CD detection, patient acceptability, and inter-observer variability of the POCT results. METHODS From 2013-2017, we prospectively recruited patients referred to secondary care with gastrointestinal symptoms, anemia and/or weight loss (group 1); and patients with self-reported gluten sensitivity with unknown CD status (group 2). All patients had concurrent POCT, IgA-tissue transglutaminase (IgA-TTG), IgA-endomysial antibodies (IgA-EMA), total IgA levels, and duodenal biopsies. Five hundred patients completed acceptability questionnaires, and inter-observer variability of the POCT results was compared among five clinical staff for 400 cases. RESULTS Group 1: 1000 patients, 58.5% female, age 16-91, median age 57. Forty-one patients (4.1%) were diagnosed with CD. The sensitivities of the POCT, IgA-TTG, and IgA-EMA were 82.9, 78.1, and 70.7%; the specificities were 85.4, 96.3, and 99.8%. Group 2: 61 patients, 83% female; age 17-73, median age 35. The POCT had 100% sensitivity and negative predictive value in detecting CD in group 2. Most patients preferred the POCT to venepuncture (90.4% vs. 2.8%). There was good inter-observer agreement on the POCT results with a Fleiss Kappa coefficient of 0.895. CONCLUSIONS The POCT had comparable sensitivities to serology, and correctly identified all CD cases in a gluten sensitive cohort. However, its low specificity may increase unnecessary investigations. Despite its advantage of convenience and rapid results, it may not add significant value to case finding in an office-based setting.
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Vriezinga S, Borghorst A, van den Akker-van Marle E, Benninga M, George E, Hendriks D, Hopman E, de Meij T, van der Meulen-de Jong A, Putter H, Rings E, Schaart M, Schweizer J, Smit M, Tabbers M, Weijerman M, Wessels M, Mearin ML. E-Healthcare for Celiac Disease-A Multicenter Randomized Controlled Trial. J Pediatr 2018; 195:154-160.e7. [PMID: 29275927 DOI: 10.1016/j.jpeds.2017.10.027] [Citation(s) in RCA: 31] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/26/2017] [Revised: 09/28/2017] [Accepted: 10/12/2017] [Indexed: 02/07/2023]
Abstract
OBJECTIVE To evaluate the (cost-)effectiveness of online consultations in follow-up of patients with celiac disease (CD). STUDY DESIGN Multicenter randomized, controlled trial involving 304 patients aged ≤25 years with CD for ≥1 year, randomized to an online (n = 156) or outpatient consultation (n = 148). An online consultation included questionnaires for symptom and growth measurement. Antitransglutaminase-type-2 antibodies were determined using a point-of-care (POC) test. Controls had a traditional consultation with antitransglutaminase-type-2 antibodies testing in laboratories. Both groups completed questionnaires concerning CD-specific health-related quality of life (HRQOL), gluten-free diet adherence, and patient satisfaction. Six months later, participants repeated HRQOL and patient satisfaction questionnaires and the POC test. The primary outcome was anti-transglutaminase-type-2 antibodies after 6 months, and the secondary outcomes were health problems, dietary adherence, HRQOL, patient satisfaction, and costs. RESULTS The performance of the POC test was inferior to laboratory testing (2/156 positive POC tests vs 13/148 positive laboratory tests; P = .003). Health problems were detected significantly more frequently using online consultation. The detection of growth problems and dietary transgressions was similar. HRQOL (from 1 [good] to 5 [poor]) improved after online consultation (from 3.25 to 3.16 [P = .013] vs controls from 3.10 to 3.23; P = .810). Patient satisfaction (from 1 [low] to 10 [high]) was 7.6 (online) vs 8.0 (controls; P = .001); 58% wished to continue online consultations. Mean costs per participant during the studied period were €202 less for the online group (P < .001). CONCLUSIONS The primary outcome could not be tested because the POC test was unreliable. Nevertheless, our results indicate that online consultations for children and young adults with CD are cost saving, increase CD-specific HRQOL, and are satisfactory for the majority. TRIAL REGISTRATION Trialregister.nl: NTR3688.
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Affiliation(s)
- Sabine Vriezinga
- Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands
| | - Annelise Borghorst
- Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands
| | | | - Marc Benninga
- Departments of Pediatrics, Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands
| | | | | | - Erica Hopman
- Department of Dietetics, Leiden University Medical Center, Leiden, The Netherlands
| | - Tim de Meij
- VU University Medical Center, Amsterdam, The Netherlands
| | | | - Hein Putter
- Department of Medical Statistics, Leiden University Medical Centre, Leiden, The Netherlands
| | - Edmond Rings
- Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands; Sophia Children's Hospital, Erasmus Medical Centre, Rotterdam, The Netherlands
| | - Maaike Schaart
- Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands
| | - Joachim Schweizer
- Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands
| | - Margot Smit
- Juliana Children's Hospital, The Hague, The Netherlands
| | - Merit Tabbers
- Departments of Pediatrics, Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands
| | | | - Margreet Wessels
- Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands; Rijnstate Hospital, Arnhem, The Netherlands
| | - M Luisa Mearin
- Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands.
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Novikova VP, Shapovalova NS. Point-of-care testing for celiac disease. DOKAZATEL'NAYA GASTROENTEROLOGIYA 2018; 7:40. [DOI: 10.17116/dokgastro2018703140] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/03/2025]
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The Role of an IgA/IgG-Deamidated Gliadin Peptide Point-of-Care Test in Predicting Persistent Villous Atrophy in Patients With Celiac Disease on a Gluten-Free Diet. Am J Gastroenterol 2017; 112:1859-1867. [PMID: 29016564 DOI: 10.1038/ajg.2017.357] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/24/2017] [Accepted: 08/05/2017] [Indexed: 12/11/2022]
Abstract
OBJECTIVES Mucosal healing is important in celiac disease (CD) for the prevention of complications. However, obtaining duodenal biopsies is invasive, and there is currently no reliable surrogate marker for histological remission in clinical practice. We aimed to assess the role of a point-of-care test (POCT) based on IgA/IgG-deamidated gliadin peptide, in detecting persistent villous atrophy (VA) in CD. METHODS We prospectively recruited patients with CD attending endoscopy for the assessment of histological remission. All patients had IgA-endomysial (EMA) antibodies, IgA-tissue transglutaminase (TTG) antibodies, and the POCT performed, and completed a validated dietary adherence questionnaire. A gastroscopy was performed in all patients, with four biopsies taken from the second part of the duodenum and one from the duodenal bulb. We compared the diagnostic performance of the surrogate markers against duodenal histology as the reference standard. RESULTS A total of 217 patients with CD (70% female, age range 16-83 years, median age 53 years) on a gluten-free diet (median duration 6 years) were recruited from 2013 to 2017. Eighty-five (39.2%) patients had persistent VA. The sensitivities of the POCT, TTG, EMA, and the adherence score in detecting VA were 67.1%, 44.7%, 37.7%, and 24.7% respectively (P=0.0005). The combination of the POCT and adherence score only marginally increased the sensitivity to 70.6% (59.7-80.0%). CONCLUSIONS The sensitivity of the POCT was higher than the other surrogate markers in predicting VA. A POCT may provide the additional advantage of an immediate objective assessment of mucosal healing at the time of an office-based follow-up consultation.
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Rauhavirta T, Hietikko M, Salmi T, Lindfors K. Transglutaminase 2 and Transglutaminase 2 Autoantibodies in Celiac Disease: a Review. Clin Rev Allergy Immunol 2016; 57:23-38. [DOI: 10.1007/s12016-016-8557-4] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
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Habtamu HB, Sentic M, Silvestrini M, De Leo L, Not T, Arbault S, Manojlovic D, Sojic N, Ugo P. A Sensitive Electrochemiluminescence Immunosensor for Celiac Disease Diagnosis Based on Nanoelectrode Ensembles. Anal Chem 2015; 87:12080-7. [DOI: 10.1021/acs.analchem.5b02801] [Citation(s) in RCA: 52] [Impact Index Per Article: 5.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/27/2023]
Affiliation(s)
- Henok B. Habtamu
- Department
of Molecular Sciences and Nanosystems, University Ca’Foscari of Venice, via Torino 155, 30172 Venezia Mestre, Italy
- Institut
des Sciences Moléculaires, CNRS UMR 5255, University of Bordeaux, ENSCBP, 33607 Pessac, France
| | - Milica Sentic
- Institut
des Sciences Moléculaires, CNRS UMR 5255, University of Bordeaux, ENSCBP, 33607 Pessac, France
- Faculty
of Chemistry, University of Belgrade, 11000 Belgrade, Serbia
| | - Morena Silvestrini
- Department
of Molecular Sciences and Nanosystems, University Ca’Foscari of Venice, via Torino 155, 30172 Venezia Mestre, Italy
| | - Luigina De Leo
- Institute for
Maternal and Child Health - IRCCS “Burlo Garofolo”, 34100 Trieste, Italy
| | - Tarcisio Not
- Institute for
Maternal and Child Health - IRCCS “Burlo Garofolo”, 34100 Trieste, Italy
- University of Trieste, 34127 Trieste, Italy
| | - Stephane Arbault
- Institut
des Sciences Moléculaires, CNRS UMR 5255, University of Bordeaux, ENSCBP, 33607 Pessac, France
| | - Dragan Manojlovic
- Faculty
of Chemistry, University of Belgrade, 11000 Belgrade, Serbia
| | - Neso Sojic
- Institut
des Sciences Moléculaires, CNRS UMR 5255, University of Bordeaux, ENSCBP, 33607 Pessac, France
| | - Paolo Ugo
- Department
of Molecular Sciences and Nanosystems, University Ca’Foscari of Venice, via Torino 155, 30172 Venezia Mestre, Italy
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Singh P, Arora S, Lal S, Strand TA, Makharia GK. Risk of Celiac Disease in the First- and Second-Degree Relatives of Patients With Celiac Disease: A Systematic Review and Meta-Analysis. Am J Gastroenterol 2015; 110:1539-1548. [PMID: 26416192 DOI: 10.1038/ajg.2015.296] [Citation(s) in RCA: 119] [Impact Index Per Article: 11.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/15/2015] [Accepted: 08/03/2015] [Indexed: 02/06/2023]
Abstract
OBJECTIVES First-degree relatives (FDRs) of patients with celiac disease (CD) are at high risk for CD and prevalence among them varies from 1.6 to 38%. The risk of having CD among FDRs if the FDR is sister, brother, mother, father, son, or daughter of index patient with CD is not known. We conducted a meta-analysis and calculated pooled prevalence of CD among FDRs, second-degree relatives (SDRs), and specific relations with index patient. METHODS On search of literature, 2,259 articles appeared of which 54 articles were included in this meta-analysis. Diagnosis of CD was based on standard criteria. RESULTS Pooled prevalence of CD was 7.5% (95% confidence interval (CI) 6.3%, 8.8%) in 10,252 FDRs and 2.3% (95% CI 1.3%, 3.8%) in 642 SDRs. Pooled prevalence of CD was highest in siblings (8.9%), followed by offsprings (7.9%) and parents (3.0%). Female FDRs had higher prevalence than male FDRs (8.4% vs. 5.2%, P=0.047). While sisters and daughters of index patient had the highest risk of having CD (1 in 7 and 1 in 8, respectively), the risk was 1 in 13 in sons, 1 in 16 in brothers, 1 in 32 in mothers, and 1 in 33 in fathers. There were also differences in the pooled prevalence of CD in FDRs according to their geographic location. CONCLUSIONS Pooled prevalence of CD among FDRs is 7.5% and varies considerably with their relationship with the index patient. The risk of CD in FDRs also varies according to gender and geographical location.
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Affiliation(s)
- Prashant Singh
- Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Shubhangi Arora
- Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | | | - Tor A Strand
- Medical Services Division, Innlandet Hospital Trust, Lillehammer, Norway
| | - Govind K Makharia
- Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India
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Hong YY, Byrnes V. Increased Detection of Celiac Disease With Measurement of Deamidated Gliadin Peptide Antibody Before Endoscopy. Clin Gastroenterol Hepatol 2015; 13:2025-6. [PMID: 25929540 DOI: 10.1016/j.cgh.2015.04.023] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/09/2015] [Revised: 04/20/2015] [Accepted: 04/22/2015] [Indexed: 02/07/2023]
Affiliation(s)
- You Yi Hong
- Medical Endoscopy Unit, Gastroenterology Department, Galway University Hospitals, Galway, Republic of Ireland
| | - Valerie Byrnes
- Medical Endoscopy Unit, Gastroenterology Department, Galway University Hospitals, Galway, Republic of Ireland
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Abstract
Among the adverse reactions caused by wheat, celiac disease (CD) is the longest studied and best-known pathology. The more recently defined non-celiac gluten sensitivity (NCGS) presents with symptoms which are often indistinguishable from CD. Diagnosis of CD is based on serologic, molecular, and bioptic testing. The IgA anti-transglutaminase (tTG) test is considered highly important, as it shows high sensitivity and specificity and its levels correlate to the degree of intestinal damage. Small bowel biopsy can be avoided in symptomatic patients with IgA anti-tTG levels above 10× the manufacturer's cut-off. Recently, tests of anti-deamidated peptides of gliadin (DGP) have replaced classic anti-native gliadin (AGA) tests. DGP assays have a considerably higher diagnostic accuracy than AGA assays, especially in the IgG class, and can replace anti-tTG tests in patients with selective IgA deficiency. The combination of IgG anti-DGP plus IgA anti-tTG assays show greater sensitivity than a single test, with very high specificity. EMA tests have great diagnostic accuracy but are not recommended by all the latest guidelines because they are observer dependent. Biopsy must still be considered the gold standard for CD diagnosis. HLA-DQ genotyping can be used to screen asymptomatic children and in cases of histology/serology disagreement. About half of NCGS patients are DQ2 positive and have IgG AGA. To diagnose NCGS, first CD and wheat allergy must be excluded; then the wheat dependence of symptoms must be verified by a gluten-free diet and subsequent gluten challenge.
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Costa S, Astarita L, Ben-Hariz M, Currò G, Dolinsek J, Kansu A, Magazzu' G, Marvaso S, Micetic-Turku D, Pellegrino S, Primavera G, Rossi P, Smarrazzo A, Tucci F, Arcidiaco C, Greco L. A point-of-care test for facing the burden of undiagnosed celiac disease in the Mediterranean area: a pragmatic design study. BMC Gastroenterol 2014; 14:219. [PMID: 25518884 PMCID: PMC4296530 DOI: 10.1186/s12876-014-0219-5] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/14/2014] [Accepted: 12/11/2014] [Indexed: 12/16/2022] Open
Abstract
BACKGROUND We aimed at assessing the factors that can influence results of the dissemination of an already validated, new generation commercial Point-of-Care Test (POCT) for detecting celiac disease (CD), in the Mediterranean area, when used in settings where it was designed to be administered, especially in countries with poor resources. METHODS Pragmatic study design. Family pediatricians at their offices in Italy, nurses and pediatricians in Slovenia and Turkey at pediatricians', schools and university primary care centers looked for CD in 3,559 (1-14 yrs), 1,480 (14-23 yrs) and 771 (1-18 yrs) asymptomatic subjects, respectively. A new generation POCT detecting IgA-tissue antitransglutaminase antibodies and IgA deficiency in a finger-tip blood drop was used. Subjects who tested positive and those suspected of having CD were referred to a Celiac Centre to undergo further investigations in order to confirm CD diagnosis. POCT Positive Predictive Value (PPV) at tertiary care (with Negative Predictive Value) and in primary care settings, and POCT and CD rates per thousand in primary care were estimated. RESULTS At tertiary care setting, PPV of the POCT and 95% CI were 89.5 (81.3-94.3) and 90 (56-98.5) with Negative Predictive Value 98.5 (94.2-99.6) and 98.7% (92-99.8) in children and adults, respectively. In primary care settings of different countries where POCT was performed by a different number of personnel, PPV ranged from 16 to 33% and the CD and POCT rates per thousand ranged from 4.77 to 1.3 and from 31.18 to 2.59, respectively. CONCLUSIONS Interpretation of POCT results by different personnel may influence the performance of POC but dissemination of POCT is an urgent priority to be implemented among people of countries with limited resources, such as rural populations and school children.
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Affiliation(s)
- Stefano Costa
- Celiac Regional Center, Pediatric Gastroenterology and Cystic Fibrosis Unit, University of Messina, Via Consolare Valeria 1, 98125, Messina, Italy.
| | - Luca Astarita
- European Laboratory for Food Induced Diseases, University of Naples Federico II, Naples, Italy.
| | - Mongi Ben-Hariz
- Pediatric Unit, Mongi SLIM's Hospital of Tunis, Marsa, Tunisia.
| | - Giovanni Currò
- Celiac Regional Center, Pediatric Gastroenterology and Cystic Fibrosis Unit, University of Messina, Via Consolare Valeria 1, 98125, Messina, Italy.
| | - Jernej Dolinsek
- University Medical Centre Pediatric Department, Ljubljanska, Maribor, Slovenia.
| | - Aydan Kansu
- Faculty of Medicine, Department of Pediatric Gastroenterology, Ankara University, Ankara, Turkey.
| | - Giuseppe Magazzu'
- Celiac Regional Center, Pediatric Gastroenterology and Cystic Fibrosis Unit, University of Messina, Via Consolare Valeria 1, 98125, Messina, Italy.
| | - Stefania Marvaso
- Celiac Regional Center, Pediatric Gastroenterology and Cystic Fibrosis Unit, University of Messina, Via Consolare Valeria 1, 98125, Messina, Italy.
| | | | - Salvatore Pellegrino
- Celiac Regional Center, Pediatric Gastroenterology and Cystic Fibrosis Unit, University of Messina, Via Consolare Valeria 1, 98125, Messina, Italy.
| | - Giuseppe Primavera
- National Health System, Azienda Sanitaria Locale 6, Associazione Culturale Pediatri, Palermo, Italy.
| | - Pasqualino Rossi
- Directorate General for European and International Relations, Ministry of Health, Rome, Italy.
| | - Andrea Smarrazzo
- European Laboratory for Food Induced Diseases, University of Naples Federico II, Naples, Italy.
| | - Francesca Tucci
- European Laboratory for Food Induced Diseases, University of Naples Federico II, Naples, Italy.
| | - Carmela Arcidiaco
- European Laboratory for Food Induced Diseases, University of Naples Federico II, Naples, Italy.
| | - Luigi Greco
- European Laboratory for Food Induced Diseases, University of Naples Federico II, Naples, Italy. .,Department of Translational Medical Science, Section of Pediatrics, University of Naples Federico II, Naples, Italy.
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Bienvenu F, Anghel SI, Besson Duvanel C, Guillemaud J, Garnier L, Renosi F, Lachaux A, Bienvenu J. Early diagnosis of celiac disease in IgA deficient children: contribution of a point-of-care test. BMC Gastroenterol 2014; 14:186. [PMID: 25376178 PMCID: PMC4289329 DOI: 10.1186/1471-230x-14-186] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/13/2014] [Accepted: 10/15/2014] [Indexed: 12/22/2022] Open
Abstract
Background The serological diagnosis of celiac disease (CD) often relies on the presence of anti-tissue transglutaminase (tTG) IgA autoantibodies. Patients suffering from selective IgA deficiency (IgAD) are often not aware of their IgA deficiency and are tested as CD negative, delaying considerably the diagnosis. The detection of IgG against deamidated gliadin peptides (DGP) has high specificity and better sensitivity than IgG anti-tTG. A multi-analytic lateral-flow immunochromatographic assay (CD-LFIA) based on the detection of IgA and IgG anti-DGP and total IgA was shown to have a good diagnostic accuracy for CD. The aim of this study was to evaluate the clinical accuracy of its use in children suffering from IgAD. Methods 45 IgAD children ranging from 1.1 to 17.4 years and suspected of CD or having high CD risk factors were referred from outpatient clinics located in the area of Rhone-Alpes (France) to the Hospices Civils de Lyon, Paediatric Hospital-Gastroenterology-Hepatology- Nutrition Department for further CD investigations. The CD investigations, including the sample collection, were performed within the Paediatric Hospital-Gastroenterology-Hepatology- Nutrition Department, and the serological testing was performed at the Lyon-Sud Hospital-Immunology Laboratory. The diagnosis of CD was based on IgG anti-tTG serology, biopsy results and patient follow-up. The serum samples were retrospectively tested on the CD-LFIA test. Results A total of eight (8) patients were diagnosed as new CD. All were correctly identified by the CD-LFIA. The test yielded four (4) false positive results. Two patients with positive IgG anti-tTG were negative on CD-LFIA, but were classified as CD negative based on biopsy results and patient follow-up. The remaining 33 patients were found negative by both methods. The specificity and sensitivity of CD-LFIA was of 89.2% [74.6-97.0] and of 100% [63.1-100] respectively. The negative predictive value (NPV) was of 100% [89.4-100], and the Likelihood Ratio for Negative Test (LR-) was of 0 [0.0-0.91]. Conclusions CD-LFIA is a useful, non-invasive and rapid tool to rule out CD in primary care paediatric patients having CD-related symptoms and IgAD. Patients having a positive CD-LFIA result could be then readily directed to secondary care setting for further evaluation by standard serology and biopsy.
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Singh P, Wadhwa N, Chaturvedi MK, Bhatia V, Saini S, Tandon N, Makharia GK, Maki M, Not T, Phillips A, Bhatnagar S. Validation of point-of-care testing for coeliac disease in children in a tertiary hospital in north India. Arch Dis Child 2014; 99:1004-1008. [PMID: 24942708 DOI: 10.1136/archdischild-2013-305567] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
OBJECTIVE Some of the conventional serological tests for coeliac disease (CD) are expensive, time-consuming and not readily available in developing countries, leading to a delay in diagnosis. Recently, point-of-care tests (POCT) have been manufactured and tested in Europe but have not been validated in our setting. We therefore aimed to study the diagnostic accuracy of the POCT 'Biocard' test in diagnosing CD in Indian children. DESIGN Cross-sectional study. SETTING Tertiary care centre in north India. PATIENTS Children, aged 2-18 years, with chronic diarrhoea, short stature or refractory anaemia underwent serological testing for CD with antiendomysial antibodies (AEA), antitissue transglutaminase (tTG) antibodies and Biocard test followed by duodenal biopsy irrespective of serological results. CD was diagnosed with positive AEA and duodenal biopsy showing >grade 2 changes using modified Marsh criteria. Those who were both AEA negative and had normal histology were considered CD negative. RESULTS Of 319 children who underwent the serological testing, 170 agreed for biopsy. Of these, 110 were diagnosed with CD and 30 were found to be CD negative. Remaining 30 had discordant AEA and histology results and were not included in analysis. Biocard test agreed with 92/110 positive and 27/30 negative diagnoses based on reference tests (83.6% sensitivity and 90% specificity). tTG was found to be 93.8% sensitive and 96.4% specific. CONCLUSIONS We successfully validated the POCT for CD in our setting. It could be used to increase case detection rates in developing countries with a large undiagnosed CD burden.
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Affiliation(s)
- Prashant Singh
- Department of Pediatrics, Center for Diarrheal Research, All India Institute of Medical Sciences, New Delhi, India
| | - Nitya Wadhwa
- Department of Pediatrics, Center for Diarrheal Research, All India Institute of Medical Sciences, New Delhi, India
| | - Mona K Chaturvedi
- Department of Pediatrics, Center for Diarrheal Research, All India Institute of Medical Sciences, New Delhi, India
| | - Vidyut Bhatia
- Department of Pediatrics, Center for Diarrheal Research, All India Institute of Medical Sciences, New Delhi, India
| | - Savita Saini
- Department of Pediatrics, Center for Diarrheal Research, All India Institute of Medical Sciences, New Delhi, India
| | - Nikhil Tandon
- Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, India
| | - Govind K Makharia
- Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India
| | - Markku Maki
- Tampere Center for Child Health Research, University of Tampere and Tampere University Hospital, Tampere, Finland
| | - Tarcisio Not
- Institute for Maternal and Child Health-IRCCS Burlo Garofolo, Trieste, and University of Trieste, Trieste, Italy
| | | | - Shinjini Bhatnagar
- Department of Pediatrics, Center for Diarrheal Research, All India Institute of Medical Sciences, New Delhi, India
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Barakauskas VE, Lam GY, Estey MP. Digesting all the options: Laboratory testing for celiac disease. Crit Rev Clin Lab Sci 2014; 51:358-78. [PMID: 25244521 DOI: 10.3109/10408363.2014.958813] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
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Mooney PD, Kurien M, Evans KE, Chalkiadakis I, Hale MF, Kannan MZ, Courtice V, Johnston AJ, Irvine AJ, Hadjivassiliou M, Sanders DS. Point-of-care testing for celiac disease has a low sensitivity in endoscopy. Gastrointest Endosc 2014; 80:456-62. [PMID: 24685008 DOI: 10.1016/j.gie.2014.02.009] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/01/2013] [Accepted: 02/06/2014] [Indexed: 12/27/2022]
Abstract
BACKGROUND Celiac disease (CD) is a common but underdiagnosed condition. A rapid point-of-care test (POCT) could reduce lead times and missed diagnoses. OBJECTIVE To assess the utility of an immunoglobulin (Ig) A tissue transglutaminase (TTG) antibody POCT in an endoscopic setting. DESIGN Prospective observational study. SETTING A single UK university hospital. PATIENTS Patients presenting with suspected CD, known CD, and routine endoscopy for upper GI symptoms. INTERVENTIONS All patients were tested with POCT, serum TTG, endomysial antibody (EMA), and upper GI endoscopy with duodenal biopsies at the same visit. MAIN OUTCOME MEASUREMENTS Comparison was made with histology in all cases, with villous atrophy regarded as diagnostic of CD. RESULTS A total of 576 patients (63.5% female, mean [± standard deviation] age 49.7 years [± 17.6 years]) were recruited. A total of 523 patients had no prior diagnosis of CD, and 53 patients had known CD coming for reassessment. A total of 117 patients were newly diagnosed with CD, and 82 were positively identified by the POCT. Sensitivity, specificity, positive predictive value, and negative predictive value were 70.1%, 96.6%, 85.4%, and 91.8%, respectively. In comparison, TTG and EMA both performed significantly better than the POCT. Sensitivity and specificity of TTG were 91.0% and 83.5%, respectively, and EMA were 83.8% and 97.5%, respectively. Of patients with known CD coming for reassessment, 26 had villous atrophy, and POCT results were positive in 16 (61.5%). There was poor agreement between POCT and standard serology. LIMITATIONS High pre-test probability of CD. CONCLUSION The performance of this POCT was disappointing compared with standard serology and cannot at present be recommended within the context of an endoscopy unit.
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Affiliation(s)
- Peter D Mooney
- Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom
| | - Matthew Kurien
- Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom
| | - Kate E Evans
- Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom
| | - Ioannis Chalkiadakis
- Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom
| | - Melissa F Hale
- Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom
| | - Mohamad Z Kannan
- Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom
| | - Victoria Courtice
- Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom
| | - Alexander J Johnston
- Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom
| | - Andrew J Irvine
- Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom
| | | | - David S Sanders
- Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom
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Point-of-care testing for coeliac disease: primary care diagnostic technology update. Br J Gen Pract 2014; 63:e426-8. [PMID: 23735415 PMCID: PMC3662461 DOI: 10.3399/bjgp13x668401] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022] Open
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George DA, Hui LL, Rattehalli D, Lovatt T, Perry I, Green M, Robinson K, Walters JRF, Brookes MJ. The role of near-patient coeliac serology testing in the follow-up of patients with coeliac disease. Frontline Gastroenterol 2014; 5:20-25. [PMID: 28839746 PMCID: PMC5369711 DOI: 10.1136/flgastro-2013-100342] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/08/2013] [Revised: 07/19/2013] [Accepted: 07/24/2013] [Indexed: 02/04/2023] Open
Abstract
OBJECTIVE This pilot study was undertaken to assess the validity and effectiveness of near-patient coeliac immunological testing, compared to standard laboratory immunological techniques, used in the context of dietician-led coeliac disease follow-up clinics. DESIGN The study was designed in two phases, each assessing the near-patient test and standard laboratory immunological techniques. Phase 1 analysed stored serum samples; Phase 2 analysed whole blood from patients attending the dietician-led coeliac disease clinics. SETTING Patients were recruited from New Cross Hospital, Wolverhampton (n=50), and Imperial College London (n=30), between March 2010 and February 2011. PATIENTS Those with a diagnosis of coeliac disease for greater than 12 months attending dietician-led coeliac disease clinics. INTERVENTIONS In addition to whole blood taken for routine analysis, patients required a capillary finger-prick blood sample. MAIN OUTCOME MEASURE To determine if the whole blood and serum near-patient test results were in correlation with outcomes of standard laboratory evaluation. RESULTS Phase 1 demonstrated that the near-patient serum test had a sensitivity of 93.5% (95% CI 0.79% to 0.98%), specificity of 94.9% (0.83% to 0.99%), when compared to standard laboratory ELISA. Phase 2, involving patients whole blood, had a sensitivity of 77.8% (0.45% to 0.93%), and specificity of 100% (0.94% to 1%). CONCLUSIONS This pilot study has demonstrated that there appears to be a role for near-patient testing in coeliac disease, but further studies are recommended.
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Affiliation(s)
- D A George
- Department of Gastroenterology, New Cross Hospital, Wolverhampton, UK
| | - L L Hui
- Department of Gastroenterology, Imperial College London, London, UK
| | - D Rattehalli
- Department of Gastroenterology, New Cross Hospital, Wolverhampton, UK
| | - T Lovatt
- Department of Gastroenterology, New Cross Hospital, Wolverhampton, UK
| | - I Perry
- Department of Gastroenterology, New Cross Hospital, Wolverhampton, UK
| | - M Green
- Department of Gastroenterology, New Cross Hospital, Wolverhampton, UK
| | - K Robinson
- Department of Gastroenterology, New Cross Hospital, Wolverhampton, UK
| | - J R F Walters
- Department of Gastroenterology, Imperial College London, London, UK
| | - M J Brookes
- Department of Gastroenterology, New Cross Hospital, Wolverhampton, UK
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Mooney PD, Kurien M, Sanders DS. Simtomax, a novel point of care test for coeliac disease. ACTA ACUST UNITED AC 2013; 7:645-51. [PMID: 24059495 DOI: 10.1517/17530059.2013.836179] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
INTRODUCTION Coeliac disease is an autoimmune condition resulting from an abnormal reaction to dietary gluten leading to small bowel villous atrophy. International prevalence studies suggest that coeliac disease affects 1% of the adult population. However, despite its high prevalence, large numbers of patients go undiagnosed. One method of increasing detection rates would be to introduce a quick screening test in the form of a finger-prick blood test. AREAS COVERED There are currently four available point-of-care tests (POCTs) available for use by health professionals. This diagnostic evaluation will review the evidence for the use of POCTs in coeliac disease including Simtomax a novel test for deamidated gliadin peptides and total IgA level. EXPERT OPINION An accurate POCT has the potential to increase the rates of diagnosis of coeliac disease if used effectively as part of a case finding approach in primary or secondary care. Evidence for the use of Simtomax is currently fairly limited only drawing comparison with laboratory serology rather than the gold standard of histology and it has only been trialled in high-risk populations. However, results to date are encouraging and further research into this area is required.
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Affiliation(s)
- Peter D Mooney
- University of Sheffield, Royal Hallamshire Hospital, Regional Gastroenterology & Liver Unit, Sheffield Teaching Hospitals Trust , Glossop Road, Sheffield S10 2JF , UK
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Benkebil F, Combescure C, Anghel SI, Besson Duvanel C, Schäppi MG. Diagnostic accuracy of a new point-of-care screening assay for celiac disease. World J Gastroenterol 2013; 19:5111-5117. [PMID: 23964145 PMCID: PMC3746383 DOI: 10.3748/wjg.v19.i31.5111] [Citation(s) in RCA: 34] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/29/2013] [Revised: 04/17/2013] [Accepted: 05/10/2013] [Indexed: 02/06/2023] Open
Abstract
AIM: To determine the diagnostic accuracy of a new point-of-care assay detecting anti-deamidated gliadin peptides in celiac disease (CD) patients.
METHODS: One-hundred-and-twelve patients (age range: 1.8-79.2 years old) with clinical symptoms suggestive of CD and/or first-degree relatives (FDR) of CD patients (n = 66), and confirmed CD on a gluten-free diet (GFD) (n = 46), were prospectively enrolled in the study at Gastroenterology outpatient clinics for adult patients and from the Gastroenterology Consultation Ward at the Pediatric Department of the University Hospital of Geneva. Written informed consent was obtained from all subjects enrolled. The study received approval from the local ethics committee. The original CD diagnosis had been based on serum-positive IgA anti-tissue transglutaminase enzyme-linked immunosorbent assay (ELISA) (QuantaLite™, Inova Diagnostics, San Diego, CA, United States) and on biopsy results. Serum samples from all study participants were tested by the new CD lateral flow immunochromatographic assay (CD-LFIA) device, Simtomax® Blood Drop (Augurix SA, BioArk, Monthey, Switzerland) to detect immunoglobulin (Ig)A and IgG antibodies against deamidated gliadin peptides. The diagnostic performance was evaluated using receiver operating characteristic curves with 95%CIs. A cut-off of 2 on the Rann colorimetric scale was used to calculate the device’s sensitivity and specificity.
RESULTS: CD-LFIA was highly accurate in detecting untreated celiac patients. In the group of patients with CD symptoms and/or FDR, eight new cases of CD were detected by ELISA and biopsy. All of these new cases were also correctly identified by CD-LFIA. The test yielded four false positive and four false negative results. The false positive results were all within the groups with clinical symptoms suggestive of CD and/or FDR, whereas the false negative results were all within the GFD group. The test yeld a sensitivity of 78.9% (95%CI: 54.4-93.9) and specificity of 95.7% (95%CI: 89.4-98.8), and the area under the curve reached 0.893 (95%CI: 0.798-0.988). The Kappa coefficient, calculated according to the values obtained by two readers from the same device, was of 0.96 (SE: 0.06). When the GFD patients were excluded from the analysis, the area under the curve reached 0.989 (95%CI: 0.971-1.000) and the Kappa coefficient, calculated according to the values obtained by two readers from the same device, became 0.96 (SE: 0.07). Furthermore, using the Rann scale cut-off of 2 without the GFD patients, sensitivity was 100% and specificity was 93.1% (95%CI: 83.3-98.1).
CONCLUSION: The new CD-LFIA rapid screening test shows good diagnostic accuracy, sensitivity and specificity, and may rule out CD in patients with CD-related symptoms.
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Hariz MB, Laadhar L, Kallel-Sellami M, Siala N, Bouraoui S, Bouziri S, Borgi A, Karouia F, Maherzi A, Makni S. Celiac disease in Tunisian children: A second screening study using a “new generation” rapid test. Immunol Invest 2013; 42:356-68. [DOI: 10.3109/08820139.2013.770012] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
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Abstract
Malabsorption syndrome encompasses numerous clinical entities that result in chronic diarrhea, abdominal distention, and failure to thrive. These disorders may be congenital or acquired and include cystic fibrosis and Shwachman-Diamond syndrome; the rare congenital lactase deficiency; glucose-galactose malabsorption; sucrase-isomaltase deficiency; adult-type hypolactasia leading to acquired lactose intolerance. The pathology may be due to impairment in absorption or digestion of nutrients resulting in Nutritional deficiency, gastrointestinal symptoms, and extra gastrointestinal symptoms. Treatment is aimed at correcting the deficiencies and symptoms to improve quality of life. Common disorders of malabsorption celiac disease, pernicious anemia, and lactase deficiency are discussed in this article.
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Affiliation(s)
- Zafreen Siddiqui
- Department of Family and Community Medicine, University of Texas Southwestern Medical Center, 5909 Harry Hines Boulevard, Suite 100, Dallas, TX 75390-9067, USA.
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Abstract
Celiac disease now affects about one person in a hundred in Europe and North America. In this review, we consider a number of important and exciting recent developments, such as clinical associations, HLA-DQ2 and HLA-DQ8 predispositions, the concept of potential celiac disease, the use of new imaging/endoscopy techniques, and the development of refractory disease. This review will be of use to all internists, pediatricians and gastroenterologists.
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Alarida K, Harown J, Ahmaida A, Marinelli L, Venturini C, Kodermaz G, Tozzoli R, Mandolesi A, Bearzi I, Catassi C. Coeliac disease in Libyan children: a screening study based on the rapid determination of anti-transglutaminase antibodies. Dig Liver Dis 2011; 43:688-91. [PMID: 21310672 DOI: 10.1016/j.dld.2011.01.002] [Citation(s) in RCA: 38] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/02/2010] [Revised: 11/19/2010] [Accepted: 01/10/2011] [Indexed: 12/11/2022]
Abstract
BACKGROUND Coeliac disease is a common disorder in North Africa; however, there are no data on coeliac disease prevalence in Libya. AIM (1) To determine coeliac disease prevalence in Libyan schoolchildren by screening with a rapid test for IgA anti-transglutaminase determination on a blood drop; (2) to evaluate the accuracy of the rapid anti-transglutaminase test. PATIENTS AND METHODS We screened 2920 students (1452 females and 1468 males) attending school in El Beida (Libya) by the rapid anti-transglutaminase test. Conventional ELISA anti-transglutaminase in rapid test positives and small intestinal biopsy in ELISA positives were performed for coeliac disease diagnosis. Conventional IgA anti-transglutaminase was performed also in 800 rapid test negative subjects. RESULTS The rapid anti-transglutaminase test was positive in 50/2920 (1.7%) subjects but only 20/50 were confirmed by the ELISA determination. The diagnosis of coeliac disease was biopsy-confirmed in 19 out of these 20. The serum ELISA IgA anti-transglutaminase was positive in 4 out of 800 rapid test negative children. Coeliac disease prevalence was 0.79-1.13%. CONCLUSIONS Coeliac disease in Libyan children is as common as in Europe, affecting around 1% of the general population. The rapid test for IgA anti-transglutaminase determination on a blood drop was not an efficient screening test.
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Affiliation(s)
- Kamla Alarida
- Department of Pediatrics, Omar Al Mukhtar University, Al Bayda, Libya
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Freeman HJ, Chopra A, Clandinin MT, Thomson ABR. Recent advances in celiac disease. World J Gastroenterol 2011; 17:2259-72. [PMID: 21633592 PMCID: PMC3098394 DOI: 10.3748/wjg.v17.i18.2259] [Citation(s) in RCA: 38] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/06/2011] [Revised: 02/12/2011] [Accepted: 02/19/2011] [Indexed: 02/06/2023] Open
Abstract
Celiac disease now affects about one person in a hundred in Europe and North America. In this review, we consider a number of important and exciting recent developments, such as clinical associations, HLA-DQ2 and HLA-DQ8 predispositions, the concept of potential celiac disease, the use of new imaging/endoscopy techniques, and the development of refractory disease. This review will be of use to all internists, pediatricians and gastroenterologists.
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Pichler J, Zilbauer M, Torrente F, Heuschkel R, Phillips A, Salvestrini C. Feasibility of a finger prick-based self-testing kit in first- and second-degree relatives of children with coeliac disease. World J Gastroenterol 2011; 17:1840-3. [PMID: 21528057 PMCID: PMC3081063 DOI: 10.3748/wjg.v17.i14.1840] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/03/2010] [Revised: 09/13/2010] [Accepted: 09/20/2010] [Indexed: 02/06/2023] Open
Abstract
AIM: To assess feasibility of a finger prick-based kit as method for self-testing of first and second-degree relatives of coeliac disease (CD) patients.
METHODS: A total number of 379 subjects were invited to participate in this study, consisting of 197 first-degree and 182 second-degree relatives of CD patients. The self-testing kit (Biocard™) was sent out with included instructions for use. Completed tests were sent back to the study coordinator for assessment.
RESULTS: One hundred and ninety-six invited relatives carried out the Biocard™ test at home. Amongst these, 70% were children. In 97% of the cases the test was performed correctly. Three tests revealed a positive result, all of which were later confirmed by serology and histology as coeliac disease.
CONCLUSION: Our study indicates that Biocard™ test is a reliable, easy to use and well-accepted tool for home testing of first- and second-degree relatives of CD patients.
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Chicco D, Taddio A, Sinagra G, Di Lenarda A, Ferrara F, Moretti M, Martelossi S, Di Toro N, Ventura A, Not T. Speeding up coeliac disease diagnosis in cardiological settings. Arch Med Sci 2010; 6:728-32. [PMID: 22419932 PMCID: PMC3298342 DOI: 10.5114/aoms.2010.17088] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/23/2009] [Revised: 07/27/2009] [Accepted: 09/27/2009] [Indexed: 02/07/2023] Open
Abstract
INTRODUCTION High prevalence of coeliac disease (CD) has been reported among patients with idiopathic dilated cardiomyopathy (DCM). We evaluated the feasibility and diagnostic accuracy of screening for CD by rapid test of anti-transglutaminase antibodies in the cardiology outpatients' clinic. MATERIAL AND METHODS We screened the blood samples of 104 patients with DCM, 44 of their first-degree relatives, 63 diseased controls and 101 healthy controls for the presence of anti-transglutaminase antibodies in a drop of whole blood using a rapid assay. This test was compared to the enzyme-linked immunosorbent assay and the anti-endomysium antibody test. RESULTS Our rapid test was positive in three (2.9%) DCM patients, in one (2%) relative and in one (1%) healthy control. These subjects were positive at both control assays. Two DCM patients had iron-deficient anaemia. The healthy relative was asymptomatic, while the healthy control experienced extreme asthenia. The relative refused intestinal biopsy, while the others showed histological evidence of CD. During the gluten-free diet, the patient with the worst left ventricular ejection fraction (LVEF) underwent heart transplant, and LVEF values improved in the other two. Anaemia and tiredness resolved in all patients. CONCLUSION Early detection of CD in a cardiological setting allows prompt treatment with a gluten-free diet of gluten-dependent complaints with potential benefits for the course of DCM.
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Affiliation(s)
- Daniela Chicco
- Cardiovascular Department, Azienda Ospedaliero-Universitaria di Trieste, Trieste, Italy
| | - Andrea Taddio
- Department of Reproductive and Development Science, University of Trieste, Institute of Child Health IRCCS “Burlo Garofolo”, Trieste, Italy
| | - Gianfranc Sinagra
- Cardiovascular Department, Azienda Ospedaliero-Universitaria di Trieste, Trieste, Italy
| | - Andrea Di Lenarda
- Cardiovascular Department, Azienda Ospedaliero-Universitaria di Trieste, Trieste, Italy
| | - Fortunato Ferrara
- Department of Reproductive and Development Science, University of Trieste, Institute of Child Health IRCCS “Burlo Garofolo”, Trieste, Italy
| | - Michele Moretti
- Cardiovascular Department, Azienda Ospedaliero-Universitaria di Trieste, Trieste, Italy
| | - Stefano Martelossi
- Department of Reproductive and Development Science, University of Trieste, Institute of Child Health IRCCS “Burlo Garofolo”, Trieste, Italy
| | - Nicola Di Toro
- Department of Reproductive and Development Science, University of Trieste, Institute of Child Health IRCCS “Burlo Garofolo”, Trieste, Italy
| | - Alessandro Ventura
- Department of Reproductive and Development Science, University of Trieste, Institute of Child Health IRCCS “Burlo Garofolo”, Trieste, Italy
| | - Tarcisio Not
- Department of Reproductive and Development Science, University of Trieste, Institute of Child Health IRCCS “Burlo Garofolo”, Trieste, Italy
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Dickey W. Diagnostic immunology in celiac disease. Expert Rev Clin Immunol 2010; 5:471-9. [PMID: 20477043 DOI: 10.1586/eci.09.26] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
Serum autoantibodies to transglutaminase and endomysium are found in the majority of patients with celiac disease, an autoimmune multisystem disorder affecting approximately 1% of Western and Middle-Eastern populations. Detection of these antibodies plays a crucial role in the diagnosis of celiac disease. The aim of this review is to summarize recent publications in this field, with particular focus on the applications and limitations of celiac autoantibody testing in routine clinical practice.
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Affiliation(s)
- William Dickey
- Department of Gastroenterology, Altnagelvin Hospital, Londonderry, Northern Ireland, BT47 6SB, UK.
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Brandt KG, Silva GAPD. [Seroprevalence of celiac disease at a general pediatric outpatient clinic]. ARQUIVOS DE GASTROENTEROLOGIA 2009; 45:239-42. [PMID: 18852954 DOI: 10.1590/s0004-28032008000300014] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/27/2007] [Accepted: 01/08/2008] [Indexed: 12/18/2022]
Abstract
BACKGROUND Celiac disease is a common problem affecting children and adults, for which early diagnosis and treatment prevent complications and deaths. Seroprevalence studies in our environment are still scarce. AIMS To determine the seroprevalence of celiac disease by using human tissue antiendomysial and anti-transglutaminase antibodies, among children and adolescents who were attended at a general pediatric outpatient clinic. METHODS This was a seroprevalence study of descriptive cross-sectional design. First, assays for guinea pig tissue anti-transglutaminase antibodies were performed. Subsequently, in the positive cases, assays for human tissue antiendomysial and anti-transglutaminase antibodies were performed. RESULTS The seroprevalence of celiac disease by means of anti-guinea pig tissue anti-transglutaminase antibodies was 5% (42/831; 95% CI: 3.76%-6.90%). Considering three positive tests, the seroprevalence was 1.9% (16/831; 95% CI: 1.83%-1.97%). The concordance of human anti-transglutaminase with antiendomysial was 71%. CONCLUSIONS The seroprevalence of celiac disease was high. Serological screening for celiac disease among children and adolescents who present signs and/or symptoms compatible with celiac disease should be performed routinely, as well as in groups already known to be at risk, given the high seroprevalence of celiac disease observed in our environment.
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Affiliation(s)
- Kátia Galeão Brandt
- Programa de Pós-Graduação em Saúde da Criança e do Adolescente, Universidade Federal de Pernambuco, Recife, PE, Brazil
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Chang M, Green PHR. Genetic testing before serologic screening in relatives of patients with celiac disease as a cost containment method. J Clin Gastroenterol 2009; 43:43-50. [PMID: 19020464 DOI: 10.1097/mcg.0b013e318187311d] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
GOALS AND BACKGROUND Relatives of patients with celiac disease have an increased lifetime risk of developing celiac disease. Repeat screening of relatives would improve diagnosis rates, but at significant cost. Genetic testing before screening would potentially reduce costs by eliminating HLA-DQ2 and DQ8 negative patients who are at extremely low risk for developing celiac disease. STUDY A decision tree was developed incorporating 3 diagnostic branches: initial screening with anti-tissue transglutaminase at time t0, repeat screening at time t1, and genetic testing before repeat screening. Costs were estimated using Medicare reimbursement fees. Modeling and sensitivity analyses were performed using Tree Age Pro 2006. RESULTS The cost of an initial screening with anti-tissue transglutaminase is approximately $434 per person. Repeat screening would cost $683, but would diagnosis an additional 4.4% cases. Genetic testing before screening would cost $750, but would decrease the lower endoscopy workload by nearly 25%. Genetic testing would have to decrease from $301 to $234, a difference of $67, to justify its use before serologic testing. As the specificity of anti-tissue transglutaminase approaches 100%, the cost of genetic testing would have to continue to decrease to less than $200 in order for it to be an affordable option. CONCLUSIONS Repeat screening of relatives with celiac disease results in a significant increase in cost, but also an associated increase in cases diagnosed. Genetic testing would potentially eliminate up to 60% of the population to be screened and, if available at a lower cost, would partially offset costs of repeat serologic screening.
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Affiliation(s)
- Matthew Chang
- Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY, USA
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Serological responses to microbial antigens in celiac disease patients during a gluten-free diet. J Clin Immunol 2008; 29:190-5. [PMID: 18987962 DOI: 10.1007/s10875-008-9255-7] [Citation(s) in RCA: 35] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2008] [Accepted: 09/16/2008] [Indexed: 01/28/2023]
Abstract
BACKGROUND Immunoglobulin A (IgA) autoantibodies to tissue transglutaminase (tTG) are commonly used for screening and diagnosing of celiac disease (CD). Seroreactivity for anti-Saccharomyces cerevisiae antibody (ASCA) and bacterial antigens have also been detected in CD patients. The aim of this study was to examine prospectively serologic responses to microbial targets in adult CD patients at the time of diagnosis and during a gluten-free diet (GFD). Further, we wanted to evaluate whether these serologic specificities could provide new tools for the follow-up of CD patients. METHODS Data on 55 adult biopsy-proven CD patients were available for follow-up study. Upper gastrointestinal endoscopy was performed on all patients. Sera from patients were tested for antibodies to tTG and ASCA and additionally analyzed with IgA enzyme-linked immunosorbent assays to Pseudomonas fluorescens-associated sequence, I2, and to a Bacteroides caccae TonB-linked outer membrane protein, OmpW. RESULTS At the time of diagnosis, 91% of CD cases were positive for tTG and 49% for ASCA; positive seroreactivity to I2 was found in 86% and to OmpW in 60% of CD patients at the time of diagnosis. The frequency of seropositivity and serum levels of these antibodies decreased during GFD. Moreover, we found that the decline in the serum levels was significant in all of these markers (p < 0.005). Interestingly, we also found that serum levels of ASCA correlated with the grade of mucosal morphology (p = 0.021), as the ASCA serum levels declined in accordance with mucosal healing. CONCLUSIONS Commensal enteric bacteria seem to play a role in the small intestinal mucosal damage in CD. This was proven by the serological responses to different microbial antigens shown in this study. Serum levels of ASCA, anti-I2, and anti-OmpW antibodies decreased significantly during GFD, indicating that these serologic markers are gluten dependent in CD patients. These specificities could provide new tools in the follow-up of CD patients.
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Comparison of a novel whole blood transglutaminase-based ELISA with a whole blood rapid antibody test and established conventional serological celiac disease assays. J Pediatr Gastroenterol Nutr 2008; 47:562-7. [PMID: 18979578 DOI: 10.1097/mpg.0b013e3181615cde] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/01/2023]
Abstract
OBJECTIVES Serum immunoglobulin A-class tissue transglutaminase (tTG-ab) and endomysial antibody (EMA) tests play a key role in the diagnostic evaluation of celiac disease. Recently, a novel whole blood rapid test based on self-tissue transglutaminase (tTG) was developed for celiac disease case finding. Based on the same principle, a whole blood self-tTG enzyme-linked immunosorbent assay (ELISA), especially applicable to large-scale screening of celiac disease, has been produced. We assessed the value of this new test in celiac disease antibody detection. PATIENTS AND METHODS The new test uses endogenous tTG found in red blood cells of whole blood in IgA-class tTG-ab measurement by detecting tTG-tTG-ab complexes formed after hemolysis of the whole blood sample. Stored whole blood samples from 150 untreated celiac disease patients and 107 control individuals without celiac disease were evaluated, and the test results were compared with those of the whole blood rapid test, 2 conventional serum-based tTG-ab ELISA tests, and 2 EMA tests. RESULTS A total of 15 whole blood samples were found to be clotted or dried after storage and were excluded from further evaluation. The whole blood ELISA test had a specificity (98%) comparable to that of the conventional serological tests, the sensitivity (91%) being slightly lower. The test was concordant with the whole blood rapid test in 92% of cases, with 2 serological ELISA tests in 91% and 94% of cases and with EMA tests in 94% and 93% of cases. CONCLUSIONS Whole blood self-tTG-based testing is accurate in celiac antibody detection, also when an ELISA method is applied. The testing requires no serum separation or external tTG.
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Federation of International Societies of Pediatric Gastroenterology, Hepatology, and Nutrition consensus report on celiac disease. J Pediatr Gastroenterol Nutr 2008; 47:214-9. [PMID: 18664878 DOI: 10.1097/mpg.0b013e318181afed] [Citation(s) in RCA: 75] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
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Korponay-Szabó IR, Szabados K, Pusztai J, Uhrin K, Ludmány E, Nemes E, Kaukinen K, Kapitány A, Koskinen L, Sipka S, Imre A, Mäki M. Population screening for coeliac disease in primary care by district nurses using a rapid antibody test: diagnostic accuracy and feasibility study. BMJ 2007; 335:1244-7. [PMID: 18063612 PMCID: PMC2137074 DOI: 10.1136/bmj.39405.472975.80] [Citation(s) in RCA: 102] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/03/2022]
Abstract
OBJECTIVE To evaluate the feasibility and diagnostic accuracy of screening for coeliac disease by rapid detection of IgA antibodies to tissue transglutaminase performed in primary care. DESIGN District nurses screened 6 year old children using rapid antibody testing of finger prick blood. They also collected capillary blood samples for laboratory determination of IgA and IgG antibodies to endomysium and IgA antibodies to tissue transglutaminase. Children with positive rapid test results were directly sent for biopsy of the small intestine. Setting Primary care in Jász-Nagykun-Szolnok county, Hungary. PARTICIPANTS 2690 children (77% of 6 year olds living in the county) and 120 nurses. MAIN OUTCOME MEASURES Positivity for antibodies to endomysium or transglutaminase in the laboratory and coeliac disease confirmed at biopsy. RESULTS 37 children (1.4%, 95% confidence interval 0.9% to 1.8%) had biopsy confirmed coeliac disease. Only five of these children had been diagnosed clinically before screening. Rapid testing had a 78.1% sensitivity (70.0% to 89.3%) and 100% specificity (88.4% to 100%) for a final diagnosis of coeliac disease by biopsy. Sensitivity was 65.1% (50.2% to 77.6%) and specificity was 100% (99.8% to 100%) compared with combined results of IgA and IgG laboratory tests. Trained laboratory workers detected 30 of the 31 newly diagnosed IgA competent patients with the rapid test kit used blindly. Median time to biopsy after a positive rapid test result was significantly shorter (20 days, range 4-148) than after a positive laboratory result (142 days, 70-256; P<0.001). Children with coeliac disease detected at screening were smaller and had worse health status than their peers but they improved on a gluten-free diet. CONCLUSIONS A simple rapid antibody test enabled primary care nurses to detect patients with coeliac disease in the community who were not picked up in clinical care. Extra training is needed to improve sensitivity.
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Affiliation(s)
- Ilma R Korponay-Szabó
- Department of Paediatrics, Medical and Health Science Centre, University of Debrecen, 4032 Debrecen, Hungary
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Catassi C, Cobellis G. Coeliac disease epidemiology is alive and kicking, especially in the developing world. Dig Liver Dis 2007; 39:908-10. [PMID: 17720636 DOI: 10.1016/j.dld.2007.07.159] [Citation(s) in RCA: 29] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/18/2007] [Accepted: 07/18/2007] [Indexed: 12/11/2022]
Affiliation(s)
- C Catassi
- Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy.
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Crovella S, Brandao L, Guimaraes R, Filho JLDL, Arraes LC, Ventura A, Not T. Speeding up coeliac disease diagnosis in the developing countries. Dig Liver Dis 2007; 39:900-2. [PMID: 17706474 DOI: 10.1016/j.dld.2007.04.016] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/15/2007] [Revised: 04/20/2007] [Accepted: 04/23/2007] [Indexed: 12/11/2022]
Abstract
BACKGROUND Anti-transglutaminase antibodies are highly predictive markers of active coeliac disease. Because limited facilities are available for routine use of anti-transglutaminase antibodies assays in developing countries, a simple, economical immunological test would represent a great step forward in the screening of coeliac disease. AIM We determined the prevalence of coeliac disease in two different populations living in an urban area and in a sub-urban impoverished area of Recife (Brazil), using two rapid tests based on detection of anti-transglutaminase antibodies in serum and in one drop of whole blood. METHODS Whole-blood and serum samples from 1074 individuals were analysed by the two rapid tests; 580 subjects were university students and 494 subjects were coming from sub-urban impoverished areas, characterized by the endemic presence of filariasis. The positive subjects were evaluated by anti-tranglutaminase enzyme linked immunosorbent assay (ELISA) assay, the coeliac disease-related HLA DQ2/8 and intestinal biopsy. RESULTS Both rapid assays were positive in 25/1074 subjects, but only 9/25 (4/4 in urban areas, specificity 100%; 5/21 in poor areas, specificity 76%) were confirmed positive by ELISA assay. The nine subjects testing positive for HLA DQ2 and the intestinal biopsy showed the typical coeliac disease lesions (coeliac disease-prevalence: 0.84%, 9/1074); seven coeliacs were asymptomatic and two presented recurrent abdominal pain. CONCLUSIONS The rapid assays were accurate in finding new coeliacs at a remarkably low cost. We are convinced that this new way of testing for coeliac disease can be successfully used by non-specialized personnel in daily practice in developing countries.
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Affiliation(s)
- S Crovella
- Department of Reproductive and Developmental Sciences, University of Trieste, Institute of Child Health I.R.C.C.S. Burlo Garofolo, Italy
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Hopper AD, Cross SS, Hurlstone DP, McAlindon ME, Lobo AJ, Hadjivassiliou M, Sloan ME, Dixon S, Sanders DS. Pre-endoscopy serological testing for coeliac disease: evaluation of a clinical decision tool. BMJ 2007; 334:729. [PMID: 17383983 PMCID: PMC1847864 DOI: 10.1136/bmj.39133.668681.be] [Citation(s) in RCA: 114] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
OBJECTIVE To determine an effective diagnostic method of detecting all cases of coeliac disease in patients referred for gastroscopy without performing routine duodenal biopsy. DESIGN An initial retrospective cohort of patients attending for gastroscopy was analysed to derive a clinical decision tool that could increase the detection of coeliac disease without performing routine duodenal biopsy. The tool incorporated serology (measuring antibodies to tissue transglutaminase) and stratifying patients according to their referral symptoms (patients were classified as having a "high risk" or "low risk" of coeliac disease). The decision tool was then tested on a second cohort of patients attending for gastroscopy. In the second cohort all patients had a routine duodenal biopsy and serology performed. SETTING Teaching hospital in Sheffield. PARTICIPANTS 2000 consecutive adult patients referred for gastroscopy recruited prospectively. MAIN OUTCOME MEASURE Evaluation of a clinical decision tool using patients' referral symptoms, tissue transglutaminase antibody results, and duodenal biopsy results. RESULTS No cases of coeliac disease were missed by the pre-endoscopy testing algorithm. The prevalence of coeliac disease in patients attending for endoscopy was 3.9% (77/2000, 95% confidence interval 3.1% to 4.8%). The prevalence in the high risk and low risk groups was 9.6% (71/739, 7.7% to 12.0%) and 0.5% (6/1261, 0.2% to 1.0%). The prevalence of coeliac disease in patients who were negative for tissue transglutaminase antibody was 0.4% (7/2000). The sensitivity, specificity, positive predictive value, and negative predictive value for a positive antibody result to diagnose coeliac disease was 90.9%, 90.9%, 28.6%, and 99.6%, respectively. Evaluation of the clinical decision tool gave a sensitivity, specificity, positive predictive value, and negative predictive value of 100%, 60.8%, 9.3%, and 100%, respectively. CONCLUSIONS Pre-endoscopy serological testing in combination with biopsy of high risk cases detected all cases of coeliac disease. The use of this decision tool may enable the endoscopist to target patients who need a duodenal biopsy.
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Affiliation(s)
- Andrew D Hopper
- Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield.
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