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Determination of Performance Characteristics of the MassPLEX Factor II/V Leiden Test

Thrombosis Clinical Trial

Official title:
A Multicenter Clinical Study to Determine the Performance Characteristics of the MassPLEX Factor II and Factor V Leiden Genotyping Test in Patients With Suspected Thrombophilia

Clinical Trial Summary

To establish the overall agreement of the MassPLEX Factor II and Factor V Leiden Genotyping Test with bi-directional DNA sequencing for Factor II and Factor V Leiden.

Clinical Trial Description

De-identified banked genomic DNA samples derived from whole blood from subjects with suspected thrombophilia will be collected from one or more clinical sites. Three clinical laboratory sites will analyze the samples with the FII/FVL Test. Bi-directional DNA sequencing will be performed on all samples at an independent core reference laboratory. ;

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01835483
Study type Observational
Source Sequenom, Inc.
Contact
Status Completed
Phase N/A
Start date May 2013
Completion date July 2013
View Details
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