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Related Experiment Videos

Inter-assay variation in antiphospholipid antibody testing.

Judith M Robert1, Lena M Macara, Elizabeth A Chalmers

  • 1Department of Obstetrics, The Queen Mother's Hospital, Glasgow, UK.

BJOG : an International Journal of Obstetrics and Gynaecology
|April 13, 2002
PubMed
Summary
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Inter-laboratory variation in anticardiolipin antibody testing shows poor agreement for IgM and fair agreement for IgG. These tests did not reliably distinguish women with recurrent miscarriage from controls.

Area of Science:

  • Immunology
  • Reproductive Medicine
  • Clinical Diagnostics

Background:

  • Anticardiolipin antibodies are associated with recurrent miscarriage.
  • Standardized diagnostic criteria are crucial for accurate patient management.

Purpose of the Study:

  • To assess inter-laboratory variability in anticardiolipin antibody testing.
  • To compare assay performance across different centers.
  • To determine the diagnostic utility of anticardiolipin antibodies in recurrent miscarriage.

Main Methods:

  • Comparative study involving three centers.
  • Analysis of anticardiolipin antibody status (IgM and IgG) in women with recurrent miscarriage and controls.
  • Evaluation of inter-assay agreement using statistical measures.

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Main Results:

  • No significant agreement beyond chance for IgM anticardiolipin antibodies between laboratories.
  • Only fair agreement observed for IgG anticardiolipin antibodies.
  • No statistically significant difference in test positivity between cases and controls.

Conclusions:

  • Current anticardiolipin antibody assays exhibit substantial inter-laboratory variation.
  • The reliability of these assays for diagnosing recurrent miscarriage is questionable.
  • Further standardization and validation of diagnostic methods are required.