Samuel D Brown, Jacqueline Hitchins, Newton Acs Wong, Amy Hayes, Alice Ogden, Adrian Heaps, Philip Bright
{"title":"在iga -组织转谷氨酰胺酶抗体弱阳性或模棱两可的患者中检测iga -肌内膜抗体在乳糜泻的诊断中是否有用？对现行NICE指南（NG20）的批评。","authors":"Samuel D Brown, Jacqueline Hitchins, Newton Acs Wong, Amy Hayes, Alice Ogden, Adrian Heaps, Philip Bright","doi":"10.1177/00045632251350488","DOIUrl":null,"url":null,"abstract":"<p><p>BackgroundCurrent coeliac disease (CD) NICE guidelines recommend testing IgA-endomysial antibodies (EMA) following a weak-positive IgA-tissue transglutaminase antibody (tTGA). Outside of patients with very high IgA-tTGA results, a positive IgA-EMA necessitates duodenal biopsy to confirm CD diagnosis, meaning a positive IgA-EMA does not alter the diagnostic pathway. Therefore, to be helpful, a negative IgA-EMA needs to reliably exclude CD.ObjectivesWe aimed to evaluate the negative predictive value (NPV) of IgA-EMA, following a weak-positive/positive IgA-tTGA, and to evaluate whether IgA-EMA result (positive or negative) affects duodenal biopsy rates.MethodsRetrospective patient cohort (<i>n</i> = 963) study of patients with IgA-EMA and IgA-tTGA testing, with or without evidence of duodenal biopsy. The NPV of IgA-EMA was assessed by comparison to duodenal biopsy. Duodenal biopsy rates were compared between patients with a positive/negative IgA-EMA (after positive/weak-positive IgA-tTGA).ResultsThe NPVs for CD of a negative IgA-EMA, in the context of a weak-positive or positive IgA-tTGA, were 41% and 0%, respectively (<i>n</i> = 45). There was a significant reduction in the proportion of patients who had a duodenal biopsy with a negative IgA-EMA (9.4%) compared to patients with a positive IgA-EMA (28.5%), following a positive/weak-positive IgA-tTGA (<i>n</i> = 963).ConclusionIgA-EMA does not reliably exclude CD following a positive/weak-positive IgA-tTGA result. Our data indicates that clinicians are utilizing a negative IgA-EMA, following a positive/weak-positive IgA-tTGA result, to inappropriately exclude CD. We recommend IgA-EMA be exclusively used in the context of a 'non-biopsy' approach to CD diagnosis, following a high positive IgA-tTGA, and that a negative IgA-EMA result should not be used to exclude CD in the context of a weak-positive/positive IgA-tTGA.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251350488"},"PeriodicalIF":2.1000,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Is there utility in testing IgA-endomysial antibodies in patients with weak-positive or equivocal IgA-tissue transglutaminase antibodies in the diagnosis of coeliac disease? A critique of current NICE guidance (NG20).\",\"authors\":\"Samuel D Brown, Jacqueline Hitchins, Newton Acs Wong, Amy Hayes, Alice Ogden, Adrian Heaps, Philip Bright\",\"doi\":\"10.1177/00045632251350488\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>BackgroundCurrent coeliac disease (CD) NICE guidelines recommend testing IgA-endomysial antibodies (EMA) following a weak-positive IgA-tissue transglutaminase antibody (tTGA). Outside of patients with very high IgA-tTGA results, a positive IgA-EMA necessitates duodenal biopsy to confirm CD diagnosis, meaning a positive IgA-EMA does not alter the diagnostic pathway. Therefore, to be helpful, a negative IgA-EMA needs to reliably exclude CD.ObjectivesWe aimed to evaluate the negative predictive value (NPV) of IgA-EMA, following a weak-positive/positive IgA-tTGA, and to evaluate whether IgA-EMA result (positive or negative) affects duodenal biopsy rates.MethodsRetrospective patient cohort (<i>n</i> = 963) study of patients with IgA-EMA and IgA-tTGA testing, with or without evidence of duodenal biopsy. The NPV of IgA-EMA was assessed by comparison to duodenal biopsy. Duodenal biopsy rates were compared between patients with a positive/negative IgA-EMA (after positive/weak-positive IgA-tTGA).ResultsThe NPVs for CD of a negative IgA-EMA, in the context of a weak-positive or positive IgA-tTGA, were 41% and 0%, respectively (<i>n</i> = 45). There was a significant reduction in the proportion of patients who had a duodenal biopsy with a negative IgA-EMA (9.4%) compared to patients with a positive IgA-EMA (28.5%), following a positive/weak-positive IgA-tTGA (<i>n</i> = 963).ConclusionIgA-EMA does not reliably exclude CD following a positive/weak-positive IgA-tTGA result. Our data indicates that clinicians are utilizing a negative IgA-EMA, following a positive/weak-positive IgA-tTGA result, to inappropriately exclude CD. We recommend IgA-EMA be exclusively used in the context of a 'non-biopsy' approach to CD diagnosis, following a high positive IgA-tTGA, and that a negative IgA-EMA result should not be used to exclude CD in the context of a weak-positive/positive IgA-tTGA.</p>\",\"PeriodicalId\":8005,\"journal\":{\"name\":\"Annals of Clinical Biochemistry\",\"volume\":\" \",\"pages\":\"45632251350488\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2025-06-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of Clinical Biochemistry\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/00045632251350488\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICAL LABORATORY TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Clinical Biochemistry","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/00045632251350488","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
Is there utility in testing IgA-endomysial antibodies in patients with weak-positive or equivocal IgA-tissue transglutaminase antibodies in the diagnosis of coeliac disease? A critique of current NICE guidance (NG20).
BackgroundCurrent coeliac disease (CD) NICE guidelines recommend testing IgA-endomysial antibodies (EMA) following a weak-positive IgA-tissue transglutaminase antibody (tTGA). Outside of patients with very high IgA-tTGA results, a positive IgA-EMA necessitates duodenal biopsy to confirm CD diagnosis, meaning a positive IgA-EMA does not alter the diagnostic pathway. Therefore, to be helpful, a negative IgA-EMA needs to reliably exclude CD.ObjectivesWe aimed to evaluate the negative predictive value (NPV) of IgA-EMA, following a weak-positive/positive IgA-tTGA, and to evaluate whether IgA-EMA result (positive or negative) affects duodenal biopsy rates.MethodsRetrospective patient cohort (n = 963) study of patients with IgA-EMA and IgA-tTGA testing, with or without evidence of duodenal biopsy. The NPV of IgA-EMA was assessed by comparison to duodenal biopsy. Duodenal biopsy rates were compared between patients with a positive/negative IgA-EMA (after positive/weak-positive IgA-tTGA).ResultsThe NPVs for CD of a negative IgA-EMA, in the context of a weak-positive or positive IgA-tTGA, were 41% and 0%, respectively (n = 45). There was a significant reduction in the proportion of patients who had a duodenal biopsy with a negative IgA-EMA (9.4%) compared to patients with a positive IgA-EMA (28.5%), following a positive/weak-positive IgA-tTGA (n = 963).ConclusionIgA-EMA does not reliably exclude CD following a positive/weak-positive IgA-tTGA result. Our data indicates that clinicians are utilizing a negative IgA-EMA, following a positive/weak-positive IgA-tTGA result, to inappropriately exclude CD. We recommend IgA-EMA be exclusively used in the context of a 'non-biopsy' approach to CD diagnosis, following a high positive IgA-tTGA, and that a negative IgA-EMA result should not be used to exclude CD in the context of a weak-positive/positive IgA-tTGA.
期刊介绍：
Annals of Clinical Biochemistry is the fully peer reviewed international journal of the Association for Clinical Biochemistry and Laboratory Medicine.
Annals of Clinical Biochemistry accepts papers that contribute to knowledge in all fields of laboratory medicine, especially those pertaining to the understanding, diagnosis and treatment of human disease. It publishes papers on clinical biochemistry, clinical audit, metabolic medicine, immunology, genetics, biotechnology, haematology, microbiology, computing and management where they have both biochemical and clinical relevance. Papers describing evaluation or implementation of commercial reagent kits or the performance of new analysers require substantial original information. Unless of exceptional interest and novelty, studies dealing with the redox status in various diseases are not generally considered within the journal''s scope. Studies documenting the association of single nucleotide polymorphisms (SNPs) with particular phenotypes will not normally be considered, given the greater strength of genome wide association studies (GWAS). Research undertaken in non-human animals will not be considered for publication in the Annals.
Annals of Clinical Biochemistry is also the official journal of NVKC (de Nederlandse Vereniging voor Klinische Chemie) and JSCC (Japan Society of Clinical Chemistry).
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