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.
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 Type
OBSERVATIONAL
Enrollment
867
Sequenom Center for Molecular Medicine
Grand Rapids, Michigan, United States
Oregon Health & Science University
Portland, Oregon, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
Performance of the MassPLEX Factor II/V Leiden Test
Overall percent agreement of the FII/FVL Test results to the bi-directional DNA sequencing results.
Time frame: Samples are collected at time of suspected thrombotic event.
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