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Related Experiment Video

Updated: May 8, 2026

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

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

Published on: September 9, 2012

An improved algorithm for activated protein C resistance and factor V Leiden screening.

Adrianna Z Herskovits¹, Elizabeth A Morgan, Susan J Lemire

¹Department of Pathology, Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115, USA.

American Journal of Clinical Pathology

|August 20, 2013

Summary

A Russell viper venom-based activated protein C resistance (APCR) screening test accurately identifies the factor V Leiden mutation, showing 99.1% sensitivity and specificity. This method can reduce unnecessary genetic testing by 80% when used strategically.

Keywords:

Activated protein C resistance Factor V Leiden Screening assays Venous thromboembolism

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A Method to Study the C924T Polymorphism of the Thromboxane A2 Receptor Gene

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Published on: April 1, 2019

Area of Science:

Hematology
Genetics
Clinical Diagnostics

Background:

Activated protein C resistance (APCR) is a common inherited thrombophilia.
The factor V Leiden mutation (G1691A allele) is the most frequent genetic cause of APCR.
Accurate and efficient screening for factor V Leiden is crucial for thrombotic risk assessment.

Purpose of the Study:

To assess the diagnostic performance of a Russell viper venom-based APCR screening test.
To compare APCR screening with DNA analysis for factor V Leiden mutation detection.
To evaluate strategies for optimizing diagnostic workflows.

Main Methods:

A cohort of 435 patients (homozygous, heterozygous, or wild-type for G1691A allele) was studied.
Concordance between Pefakit APCR screening results and DNA analysis was evaluated.
Receiver operating characteristic (ROC) analysis was employed to determine optimal cutoff values.

Main Results:

An APCR ratio cutoff of 1.89 demonstrated 99.1% sensitivity and specificity.
The APCR test showed high concordance with DNA analysis for factor V Leiden.
In cases with genotype-phenotype discrepancies, APCR results may offer greater clinical relevance.

Conclusions:

Initial APCR screening followed by targeted molecular analysis for borderline cases significantly reduces unnecessary testing (by ~80%).
This reflex testing strategy maintains high diagnostic accuracy for factor V Leiden.
APCR screening offers an efficient approach to managing thrombophilia diagnostics.