NCT01835483

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 867 (actual)
• Sponsor: Sequenom, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Factor V Leiden
• Factor II
• Thrombosis

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-04-19
• Last updated: 2014-01-20

Locations

3 sites across 1 country: United States