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

Sequenom

Status: Completed

Conditions: Factor V Leiden; Thrombosis; Factor II

Study type: Observational

Funder types: Industry

Identifiers

NCT01835483

SQNM-FVL-300

Details and patient eligibility

About

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.

Full 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.

Enrollment: 867 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• suspected thrombophilia
• 18 years of age or older

Exclusion criteria

• none