The Factor V Leiden Kit allows the detection and genotyping of a single point mutation, G→A at position 1691, in the human Factor V gene. This mutation is referred to as Factor V Leiden. The Factor V Leiden Kit is an in vitro diagnostic test for the detection and genotyping of the Factor V Leiden mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test must be performed on the LightCycler® 2.0 Instrument according to the workflow described in the pack insert.
A 222 bp fragment of the Factor V gene is amplified by polymerase chain reaction (PCR) using DNA isolated from human whole peripheral blood and is detected by a pair of specific fluorescent hybridisation probes. The genotype of the Factor V gene is determined by melting curve analysis immediately after amplification is completed.