American Diagnostica Inc has introduced the ACTICLOT® Protein C Resistance (APC-R) assay to complement its special coagulation product line. The APC-R test is a clot-based assay for determining the presence of the Factor V Leiden mutation, the most common hereditary thrombophilic disorder in the United States. The Factor V Leiden mutation, present in about 5% of Caucasians and 1.2% of African-Americans, alters the structure of factor V blood protein, causing resistance to inactivation by activated protein C (aPC). More than 80% of all deep vein thrombosis is due to the aPC resistance phenotype. The thrombotic risk of heterozygous carriers is increased five- to 10-fold, whereas homozygous carriers have a 50- to 100-fold increase in thrombotic risk. In clinical studies, the APC-R test demonstrated 100% specificity and 100% sensitivity. The major advantages of APC-R include its simplicity in design and use, and its ability to clearly distinguish homozygous, heterozygous Factor V Leiden carriers and wild type individuals without molecular genetic testing. Unlike other coagulation-based assays, most blood factor deficiencies, inhibitors, or Lupus anticoagulants do not affect the APC-R assay.

American Diagnostica Inc
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