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'Pre-endoscopy point of care test (Simtomax- IgA/IgG-Deamidated Gliadin Peptide) for coeliac disease in iron deficiency anaemia: diagnostic accuracy and a cost saving economic model'.
BMC Gastroenterol 2016; 16:115BG

Abstract

BACKGROUND

International guidelines recommend coeliac serology in iron deficiency anaemia, and duodenal biopsy for those tested positive to detect coeliac disease. However, pre-endoscopy serology is often unavailable, thus committing endoscopists to take routine duodenal biopsies. Some endoscopists consider duodenal biopsy mandatory in anaemia to exclude other pathologies. We hypothesise that using a point of care test at endoscopy could fill this gap, by providing rapid results to target anaemic patients who require biopsies, and save costs by biopsy avoidance. We therefore assessed three key aspects to this hypothesis: 1) the availability of pre-endoscopy serology in anaemia; 2) the sensitivities and cost effectiveness of pre-endoscopy coeliac screening with Simtomax in anaemia; 3) whether other anaemia-related pathologies could be missed by this targeted-biopsy approach.

METHODS

Group 1: pre-endoscopy serology availability was retrospectively analysed in a multicentre cohort of 934 anaemic patients at 4 UK hospitals. Group 2: the sensitivities of Simtomax, endomysial and tissue-transglutaminase antibodies were compared in 133 prospectively recruited patients with iron deficiency anaemia attending for a gastroscopy. The sensitivities were measured against duodenal histology as the reference standard in all patients. The cost effectiveness of Simtomax was calculated based on the number of biopsies that could have been avoided compared to an all-biopsy approach. Group 3: the duodenal histology of 153 patients presenting to a separate iron deficiency anaemia clinic were retrospectively reviewed.

RESULTS

In group 1, serology was available in 361 (33.8 %) patients. In group 2, the sensitivity and negative predictive value (NPV) were 100 % and 100 % for Simtomax, 96.2 % and 98.9 % for IgA-TTG, and 84.6 % and 96.4 % for EMA respectively. In group 3, the duodenal histology found no causes for anaemia other than coeliac disease.

CONCLUSION

Simtomax had excellent diagnostic accuracy in iron deficiency anaemia and was comparable to conventional serology. Duodenal biopsy did not identify any causes other than coeliac disease for iron deficiency anaemia, suggesting that biopsy avoidance in Simtomax negative anaemic patients is unlikely to miss other anaemia-related pathologies. Due to its 100 % NPV, Simtomax could reduce unnecessary biopsies by 66 % if only those with a positive Simtomax were biopsied, potentially saving £3690/100 gastroscopies.

TRIAL REGISTRATION

The group 2 study was retrospectively registered with clinicaltrials.gov. Trial registration date: 13(th) July 2016;

TRIAL REGISTRATION NUMBER

NCT02834429 .

Authors+Show Affiliations

Academic Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Sheffield, UK. michellelau@doctors.org.uk.Academic Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Sheffield, UK.Academic Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Sheffield, UK.Department of Gastroenterology, Bradford Royal Infirmary, Bradford, UK.Department of Gastroenterology, Bradford Royal Infirmary, Bradford, UK.Department of Gastroenterology, Whipps Cross University Hospital, London, UK.Department of Gastroenterology, Addenbrooke's Hospital, Cambridge, UK.Department of Gastroenterology, Addenbrooke's Hospital, Cambridge, UK.Department of Gastroenterology, Addenbrooke's Hospital, Cambridge, UK.Department of Gastroenterology, Hull Royal Infirmary, Hull, UK.Department of Gastroenterology, Hull Royal Infirmary, Hull, UK.Academic Unit of Pathology, Department of Neuroscience, Faculty of Medicine, Dentistry & Health, The University of Sheffield, Sheffield, UK.Department of Gastroenterology, Northern General Hospital, Sheffield Teaching Hospitals, Sheffield, UK.Department of Gastroenterology, Whipps Cross University Hospital, London, UK.Academic Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Sheffield, UK.

Pub Type(s)

Evaluation Studies
Journal Article
Multicenter Study

Language

eng

PubMed ID

27628523

Citation

Lau, Michelle Shui Yee, et al. "'Pre-endoscopy Point of Care Test (Simtomax- IgA/IgG-Deamidated Gliadin Peptide) for Coeliac Disease in Iron Deficiency Anaemia: Diagnostic Accuracy and a Cost Saving Economic Model'." BMC Gastroenterology, vol. 16, 2016, p. 115.
Lau MS, Mooney P, White W, et al. 'Pre-endoscopy point of care test (Simtomax- IgA/IgG-Deamidated Gliadin Peptide) for coeliac disease in iron deficiency anaemia: diagnostic accuracy and a cost saving economic model'. BMC Gastroenterol. 2016;16:115.
Lau, M. S., Mooney, P., White, W., Appleby, V., Moreea, S., Haythem, I., ... Sanders, D. (2016). 'Pre-endoscopy point of care test (Simtomax- IgA/IgG-Deamidated Gliadin Peptide) for coeliac disease in iron deficiency anaemia: diagnostic accuracy and a cost saving economic model'. BMC Gastroenterology, 16, p. 115. doi:10.1186/s12876-016-0521-5.
Lau MS, et al. 'Pre-endoscopy Point of Care Test (Simtomax- IgA/IgG-Deamidated Gliadin Peptide) for Coeliac Disease in Iron Deficiency Anaemia: Diagnostic Accuracy and a Cost Saving Economic Model'. BMC Gastroenterol. 2016 Sep 15;16:115. PubMed PMID: 27628523.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 'Pre-endoscopy point of care test (Simtomax- IgA/IgG-Deamidated Gliadin Peptide) for coeliac disease in iron deficiency anaemia: diagnostic accuracy and a cost saving economic model'. AU - Lau,Michelle Shui Yee, AU - Mooney,Peter, AU - White,William, AU - Appleby,Victoria, AU - Moreea,Sulleman, AU - Haythem,Ismail, AU - Elias,Joshua, AU - Bundhoo,Kiran, AU - Corbett,Gareth, AU - Wong,Liam, AU - Tsai,Her Hsin, AU - Cross,Simon, AU - Hebden,John, AU - Hoque,Sami, AU - Sanders,David, Y1 - 2016/09/15/ PY - 2016/04/19/received PY - 2016/08/16/accepted PY - 2016/9/16/entrez PY - 2016/9/16/pubmed PY - 2017/2/12/medline KW - Coeliac disease KW - Diagnostic tests KW - Endoscopy KW - Health economics KW - Histopathology KW - Iron deficiency anaemia KW - Screening KW - Small intestine SP - 115 EP - 115 JF - BMC gastroenterology JO - BMC Gastroenterol VL - 16 N2 - BACKGROUND: International guidelines recommend coeliac serology in iron deficiency anaemia, and duodenal biopsy for those tested positive to detect coeliac disease. However, pre-endoscopy serology is often unavailable, thus committing endoscopists to take routine duodenal biopsies. Some endoscopists consider duodenal biopsy mandatory in anaemia to exclude other pathologies. We hypothesise that using a point of care test at endoscopy could fill this gap, by providing rapid results to target anaemic patients who require biopsies, and save costs by biopsy avoidance. We therefore assessed three key aspects to this hypothesis: 1) the availability of pre-endoscopy serology in anaemia; 2) the sensitivities and cost effectiveness of pre-endoscopy coeliac screening with Simtomax in anaemia; 3) whether other anaemia-related pathologies could be missed by this targeted-biopsy approach. METHODS: Group 1: pre-endoscopy serology availability was retrospectively analysed in a multicentre cohort of 934 anaemic patients at 4 UK hospitals. Group 2: the sensitivities of Simtomax, endomysial and tissue-transglutaminase antibodies were compared in 133 prospectively recruited patients with iron deficiency anaemia attending for a gastroscopy. The sensitivities were measured against duodenal histology as the reference standard in all patients. The cost effectiveness of Simtomax was calculated based on the number of biopsies that could have been avoided compared to an all-biopsy approach. Group 3: the duodenal histology of 153 patients presenting to a separate iron deficiency anaemia clinic were retrospectively reviewed. RESULTS: In group 1, serology was available in 361 (33.8 %) patients. In group 2, the sensitivity and negative predictive value (NPV) were 100 % and 100 % for Simtomax, 96.2 % and 98.9 % for IgA-TTG, and 84.6 % and 96.4 % for EMA respectively. In group 3, the duodenal histology found no causes for anaemia other than coeliac disease. CONCLUSION: Simtomax had excellent diagnostic accuracy in iron deficiency anaemia and was comparable to conventional serology. Duodenal biopsy did not identify any causes other than coeliac disease for iron deficiency anaemia, suggesting that biopsy avoidance in Simtomax negative anaemic patients is unlikely to miss other anaemia-related pathologies. Due to its 100 % NPV, Simtomax could reduce unnecessary biopsies by 66 % if only those with a positive Simtomax were biopsied, potentially saving £3690/100 gastroscopies. TRIAL REGISTRATION: The group 2 study was retrospectively registered with clinicaltrials.gov. Trial registration date: 13(th) July 2016; TRIAL REGISTRATION NUMBER: NCT02834429 . SN - 1471-230X UR - https://www.unboundmedicine.com/medline/citation/27628523/'Pre_endoscopy_point_of_care_test__Simtomax__IgA/IgG_Deamidated_Gliadin_Peptide__for_coeliac_disease_in_iron_deficiency_anaemia:_diagnostic_accuracy_and_a_cost_saving_economic_model'_ L2 - https://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-016-0521-5 DB - PRIME DP - Unbound Medicine ER -