Performance of a new rapid whole blood coeliac test in adult patients with low prevalence of endomysial antibodies

Dig Liver Dis. 2007 Dec;39(12):1057-63. doi: 10.1016/j.dld.2007.09.005. Epub 2007 Nov 5.

Abstract

Background: In coeliac disease endomysial and transglutaminase autoantibodies are directed against the human autoantigen, transglutaminase. The conventional coeliac antibody tests are performed from serum samples in centralized laboratories.

Aims: To evaluate a rapid and easy immunoglobulin A-class whole blood point-of-care test and its commercial application, the Biocard test, in coeliac autoantibody detection.

Methods: In the whole blood point-of-care test transglutaminase is liberated from the red blood cells by haemolysis. Transglutaminase antibodies, if present, complex with the liberated antigen, and are visualized. Altogether 51 biopsy-proven untreated coeliac adult patients, 48 of the same patients after treatment, and 36 controls were tested. The point-of-care test results were compared with serum endomysial and transglutaminase antibody and Biocard test results and histology.

Results: The whole blood point-of-care test was as sensitive (82%) as the serum endomysium test (80%) in detecting untreated coeliac disease while the serum transglutaminase antibody test was superior (88%). The tests had 100% specificity. A positive point-of-care test result seroconverted or the test reaction weakened in 90% of the treated coeliac patients. Biocard test-positive were 22 of the 24 tested untreated coeliac patients. Biocard test-negative were 15 of 19 controls.

Conclusions: The whole blood rapid tests are as reliable as the conventional serological tests in detecting untreated coeliac disease and in coeliac disease diet monitoring.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Autoantibodies / blood*
  • Autoantigens / immunology
  • Celiac Disease / blood*
  • Celiac Disease / immunology
  • Erythrocytes / enzymology
  • Erythrocytes / immunology
  • Female
  • Humans
  • Immunoglobulin A / analysis
  • Male
  • Middle Aged
  • Muscle Fibers, Skeletal / immunology
  • Muscle, Smooth, Vascular / enzymology
  • Muscle, Smooth, Vascular / immunology*
  • Point-of-Care Systems
  • Predictive Value of Tests
  • Reagent Kits, Diagnostic
  • Reticulin / immunology*
  • Transglutaminases / immunology

Substances

  • Autoantibodies
  • Autoantigens
  • Immunoglobulin A
  • Reagent Kits, Diagnostic
  • Reticulin
  • Transglutaminases