Status:
COMPLETED
Dengue Virus NS1 Antigen (Bio-Rad) Clinical Protocol
Lead Sponsor:
Bio-Rad Laboratories
Collaborating Sponsors:
American National Red Cross
Centers for Disease Control and Prevention
Conditions:
Mass Screening
Eligibility:
All Genders
16+ years
Brief Summary
The purpose of the study is to screen blood donors for the presence of NS1 antigen of the dengue virus at the American Red Cross in Puerto Rico region (and Monroe County, Florida) using the Platelia D...
Detailed Description
Dengue is an endemic disease that is increasingly more common in tropical climates and the dengue epidemic in Puerto Rico (May 2009) presents a risk to the blood supply in Puerto Rico. Also, on July 1...
Eligibility Criteria
Inclusion
- The Puerto Rico Region and Monroe County, Florida will maintain a log of all blood donors enrolled by collection date documenting the time of collection, centrifugation and freezing; only centrifuged and frozen PPTs will be sent to the Charlotte NTL for NS1 Ag testing. Samples frozen when received at the Charlotte NTL will be tested. Samples that arrive thawed will be tested if the time unfrozen is 24 hours or less. When necessary, alternate PPTs (surplus samples used for NAT) will be used for dengue NS1 Ag testing; a log will be kept by the Charlotte NTL documenting the sample identification numbers of thawed samples, approximate time unfrozen and the samples that require an alternate PPT for dengue NS1 Ag testing.
Exclusion
- Samples that are deemed unacceptable for testing include those held for excessive storage times when thawed (in excess of 24 hours unfrozen or otherwise as determined by the Principal Investigator) or that are cracked or otherwise damaged. Samples having inadequate volume for initial and repeat testing in duplicate will not be tested as determined by the Charlotte NTL; a log will be kept of samples unacceptable for testing and the reason that the samples are unsuitable for testing.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
182353 Patients enrolled
Trial Details
Trial ID
NCT01226173
Start Date
March 1 2010
End Date
August 1 2012
Last Update
September 24 2012
Active Locations (2)
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1
Community Blood Centers of Florida, Inc.
Lauderhill, Florida, United States, 33313
2
American Red Cross
San Juan, Puerto Rico, 00936