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Measurement of Factor V Activity in Human Plasma Using a Microplate Coagulation Assay

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Published on: September 9, 2012

Laboratory testing for factor inhibitors.

E J Favaloro¹, B Verbruggen, C H Miller

¹Diagnostic Haemostasis, Haematology Department, Institute of Clinical Pathology and Medical Research (ICPMR), Pathology West, Westmead Hospital, Westmead, NSW, Australia.

Haemophilia : the Official Journal of the World Federation of Hemophilia

|April 26, 2014

Summary

Inhibitor assays are crucial for diagnosing and managing hemophilia. This study details assay methods, highlights significant inter-laboratory variability, and offers strategies to improve diagnostic accuracy for better patient care.

Keywords:

assay variation diagnostic accuracy factor inhibitors fluorescence immunoassay haemophilia low titre inhibitors

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Area of Science:

Hematology
Clinical Diagnostics

Background:

Inhibitor assays are vital for diagnosing acquired hemophilia and monitoring congenital hemophilia.
Assays are used when patients have prolonged coagulation times, unusual bleeding, or unexpected factor levels post-treatment.

Purpose of the Study:

To describe inhibitor assays, their development, and associated testing pitfalls.
To present strategies for overcoming challenges and discuss alternative testing approaches.

Main Methods:

Review of inhibitor assay methodologies.
Analysis of inter-laboratory variability and sources of error.
Discussion of diagnostic interpretation and confirmation strategies.

Main Results:

Significant inter-laboratory coefficient of variation (often exceeding 50%) persists.
False negative/positive results and variability have not improved over recent years.
Appropriate interpretation, repeat testing, and recovery assessment are critical.

Conclusions:

Standardization and improved accuracy of inhibitor assays are needed.
Addressing inter-laboratory variability is essential for reliable hemophilia management.
Careful interpretation and confirmation testing enhance diagnostic value.