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Comparison of Phenotypic Activated Protein C Resistance Testing With a Genetic Assay for Factor V Leiden
Colin H Murphy1, Daniel E Sabath1
1Department of Laboratory Medicine, Division of Clinical Coagulation, University of Washington, Seattle.
Objectives:
To compare the accuracy and reliability of phenotypic activated protein C resistance (aPC-R) assays with a genotypic assay for the factor V Leiden F5 p.R506Q (FVL) mutation.
Methods:
Data were obtained from an electronic data warehouse for FVL testing performed at an academic institution with a large referral laboratory service. In total, 1,596 patients were identified who had undergone both phenotypic aPC-R and genotypic FVL mutation testing.
Results:
Phenotypic testing showed a high level of sensitivity, specificity, and other biostatistical values compared with genotypic testing. Improvements in technology decreased the amount of equivocal phenotypic results.
Conclusions:
Phenotypic assays had close to total concordance with genotypic assays over 16 years of testing. Changing ordering practices could result in up to an 80% reduction in testing costs.
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