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Interlaboratory variation in antiphospholipid antibody testing.

A M Peaceman¹, R K Silver, S N MacGregor

¹Department of Obstetrics and Gynecology, Northwestern University Medical School, Chicago, IL 60611.

American Journal of Obstetrics and Gynecology

|June 1, 1992

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Antiphospholipid antibody testing shows significant variation between labs, especially for anticardiolipin antibodies. This inconsistency in lupus anticoagulant and anticardiolipin antibody testing may lead to inappropriate patient treatments.

Area of Science:

Clinical Immunology
Reproductive Medicine
Laboratory Medicine

Background:

Antiphospholipid antibody testing is crucial for diagnosing recurrent pregnancy loss.
Standardization of these tests is essential for reliable patient management.

Purpose of the Study:

To assess the consistency of anticardiolipin antibody and lupus anticoagulant testing across different laboratories.
To identify potential sources of interlaboratory variation in antiphospholipid antibody assays.

Main Methods:

A questionnaire was distributed to ten laboratories (five university-based, five commercial) regarding their antiphospholipid antibody testing protocols.
Blood samples from 20 patients were tested by these laboratories for anticardiolipin antibody and lupus anticoagulant.

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Main Results:

Significant differences in methods, standardization, and reporting units were observed among laboratories.
Anticardiolipin antibody testing showed considerable variability, with only 25% agreement among all laboratories for specimen positivity.
Lupus anticoagulant testing was more reproducible, though one laboratory reported discordant results.

Conclusions:

Substantial interlaboratory variation exists in antiphospholipid antibody testing, particularly for anticardiolipin antibodies.
This variability may contribute to unnecessary therapeutic interventions in patients with recurrent pregnancy loss.