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Clinical Trial Summary

As part of a system wide reagent verification plan Haemoscope Corporation will be running a study to verify the reference intervals of many of the reagents. Reference intervals will be constructed following the guidelines set out in CLSI document C28-A3c. This guideline calls for a reference interval to be constructed from at least 120 donors. Some reagents currently have ranges in place based on fewer donors than that stated in the guideline. This procedure will provide additional testing results to meet the requirements outlined in the CLSI guideline. Reagents that currently have no reference intervals will be tested and will include a minimum of 146 donors.


Clinical Trial Description

n/a


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01357928
Study type Observational
Source Haemonetics Corporation
Contact
Status Completed
Phase N/A
Start date April 2011
Completion date October 2011

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