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

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.

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Key information

Conditions

Detection and Genotyping of Factor V and Factor II Point Mutations

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria for this test, since the genomic sequence will not vary by ethnicity, gender, age or disease. Inappropriately stored blood samples will be excluded.

Sponsors and collaborators

Lead sponsor

Illumina, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Aug 14, 2009
Registry last updated: Jun 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.