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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Samples are collected at time of suspected thrombotic event. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with suspected thrombophilia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sequenom Center for Molecular Medicine | Grand Rapids | Michigan | 49503 | United States | ||
| Oregon Health & Science University |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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De-identified banked genomic DNA
| Portland |
| Oregon |
| 97239 |
| United States |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | United States |