Factor V Leiden
- GTR Test IDHelpEach Test is a specific, orderable test from a particular laboratory, and is assigned a unique GTR accession number. The format is GTR00000001.1, with a leading prefix 'GTR' followed by 8 digits, a period, then 1 or more digits representing the version. When a laboratory updates a registered test, a new version number is assigned.: GTR000502872.4
- Last updated: 2021-10-14
- Annual Review past due read more
- Test version history
Clinical testHelpIn the U.S., clinical tests must be performed under CLIA certification. When a lab uses the same methods for a test in both clinical and research settings, the test appears as two separate GTR records. for Thrombophilia due to activated protein C resistance
Offered by Center for Genetics at Saint Francis
Methodology
Methodology
HelpThe assay's major method category (biochemical, cytogenetic or molecular genetics); method category (i.e. enzyme assay, chromosome breakage studies, targeted mutation analysis); methodology (i.e. the name of the method used) and instruments used when performing this test.- Molecular Genetics
- TTargeted variant analysis
- Gold nanoparticle probe technology
- Nanosphere Verigene System
Test development
HelpHow the test was developed (e.g. Laboratory Developed Test (LDT), FDA reviewed, externally manufactured kit, modified FDA-reviewed test, or combination). Intended to help differentiate certification requirements between the test types. Reflex testing not included here.FDA-reviewed (has FDA test name)
Test procedure
HelpSummary of the test methodology and/ or description of the specific steps for each method used in this assay.Confirmation is performed on a new blood specimen (if submitted) and a separate DNA preparation using the same methodology
Citations
Not provided
Confirmation is performed on a new blood specimen (if submitted) and a separate DNA preparation using the same methodology
- NICE, 2020UK NICE Guideline NG158, Venous thromboembolic diseases: diagnosis, management and thrombophilia testing, 2020
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