Detection of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A Point Mutations in DNA

VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00959504

Enrollment

275

Registered

2009-08-14

Start date

2009-08-31

Completion date

2009-09-30

Last updated

2011-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Detection and Genotyping of Factor V and Factor II Point Mutations

Brief summary

As an external validation test of the performance of the VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System, clinical trials will be conducted at three sites. This study will assess genotyping accuracy as compared to bidirectional sequencing and genotyping reproducibility across variables such as user, day, and site.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

* Patient samples will be leftover EDTA-anticoagulated whole blood from patients referred for Factor V and/or Factor II testing.

Exclusion criteria

* There are no applicable

Outcome results