A proposed reference change value for an IgA anti-tissue transglutaminase immunoassay to improve interpretation of serial results in celiac patients

Clin Chim Acta. 2013 Jun 5:421:12-6. doi: 10.1016/j.cca.2013.02.031. Epub 2013 Mar 5.

Abstract

Background: Celiac disease (CD) is an autoimmune disorder caused by an inappropriate immunological response to gluten ingestion in genetically susceptible individuals. IgA anti-tissue transglutaminase (tTG) antibodies have been widely employed as a specific biochemical marker for CD. Recent studies have also shown its usefulness in evaluating patient compliance with a gluten-free diet.

Methods: A group of 28 subjects with CD was selected for the study. Each fulfilled the requirement of a gluten-free diet for more than one year. IgA anti-tTG determination was performed every two months for half a year. These data were used to estimate the biological variation (BV) of IgA anti-tTG in celiac patients and to calculate the reference change value (RCV).

Results: The within-subject biological variation (CVI) and between-subject biological variation (CV(G)) were 19.2% and 75.6%, respectively, and the index of individuality was 0.25. The RCV calculated using these data together with our analytical imprecision (5.7%) was 55.5% for a 95% level of significance.

Conclusions: We have determined for the first time the BV and the RCV for IgA anti-tTG in a celiac population. This value and the probability curve generated from our data could be a valuable tool for monitoring patients' adherence to dietary treatment.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Celiac Disease / blood*
  • Celiac Disease / diagnosis
  • Celiac Disease / diet therapy
  • Celiac Disease / immunology
  • Diet, Gluten-Free*
  • Female
  • Humans
  • Immunoassay / standards*
  • Immunoglobulin A / blood*
  • Male
  • Middle Aged
  • Observer Variation
  • Patient Compliance
  • Reference Values
  • Sensitivity and Specificity
  • Transglutaminases / immunology

Substances

  • Immunoglobulin A
  • Transglutaminases