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Diagnostic accuracy of a fully automated multiplex celiac disease antibody panel for serum and plasma

Jeff Terryberry1, Jani Tuomi2, Subo Perampalam3

  • 1SQI Diagnostics Systems Inc., 36 Meteor Dr. Toronto, ON M9W 1A4, Canada, Phone: +416-674-9500.

Clinical Chemistry and Laboratory Medicine
|March 24, 2019
PubMed

Insights

A new automated multiplex test for celiac disease (CD) improves diagnostic accuracy by measuring multiple antibodies. This method enhances the likelihood of confirming CD and monitoring gluten-free diet adherence.

Area of Science:

  • Immunology
  • Gastroenterology
  • Clinical Diagnostics

Background:

  • Celiac disease (CD) diagnosis can be improved with automated multiplex testing using capillary blood for higher throughput.
  • Enhancing diagnostic accuracy through likelihood ratios for post-test probability is crucial for ruling in CD.

Purpose of the Study:

  • To evaluate the diagnostic accuracy of the Ig_plex™ Celiac Disease Panel on the sqidlite™ automated platform.
  • To compare multiplex antibody testing with conventional single antibody ELISA tests for celiac disease.

Main Methods:

  • The Ig_plex™ Celiac Disease Panel measured IgA and IgG antibodies to tissue transglutaminase (tTG) and deamidated gliadin peptides (DGP) in 224 CD serum or plasma samples.
  • Diagnostic accuracy metrics were applied to combined multiplex test results and compared to single antibody ELISA tests.

Main Results:

  • Multiple positive antibody results increased the post-test probability of ruling in untreated and treated CD to over 90%.
  • Measurement of all four CD antibodies generated accuracy profiles that can monitor gluten-free diet (GFD) treatment response.
  • Positive tTG and DGP antibodies were more frequent in untreated CD (81%-94%) than treated CD (44%-64%).
  • Plasma and serum agreement was high (≥98%), with 100% agreement between venous and capillary plasma.

Conclusions:

  • The Ig_plex™ Celiac Disease Panel enhances CD confirmation likelihood via multi-reactive markers and post-test probability.
  • Specific antibody positivity profiles and cut-off intervals aid in monitoring GFD treatment and disease progression.
  • Serum, venous, and capillary plasma provide comparable and accurate results for celiac disease antibody testing.

Keywords:
celiac diseasediagnostic accuracyglutenlikelihood ratiomultiplexing

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