Determination of Performance Characteristics of the MassPLEX Factor II/V Leiden Test
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/1/2014 |
| Start Date: | April 2013 |
| End Date: | June 2013 |
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
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.
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.
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.
Inclusion Criteria:
- suspected thrombophilia
- 18 years of age or older
Exclusion Criteria:
- none
We found this trial at
3
sites
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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