Factor V Leiden Kit

Detection and genotyping of a single point mutation of the human Factor V gene

An in vitro diagnostic test that allows the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood.
This test is performed on the LightCycler® Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor V DNA recovered from clinical samples and fluorigenic target-specific hybridization for the detection and genotyping of the amplified Factor V DNA.

Intended Use

(FDA-IVD)
The Factor V Leiden Kit allows the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler® 1.2 Instrument utilizing PCR for the amplification of Factor V DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection and genotyping of the amplified Factor V DNA. The Factor V Leiden test 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 is intended to be used on the LightCycler® 1.2 Instrument using the LightCycler® Software 3.5. The specimen preparation must be performed according to the workflow procedures described in the package insert.

(CE-IVD)
The Factor V Leiden Kit allows the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler® 2.0 Instrument utilizing PCR for the amplification of Factor V DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection and genotyping of the amplified Factor V DNA. The Factor V Leiden test 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 is intended to be used on the LightCycler® 2.0 Instrument using the LightCycler® Software 4.05 or 4.1. The specimen preparation must be performed according to the workflow procedures described in the package insert.