Dengue Virus NS1 Antigen (Bio-Rad) Clinical Protocol
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 Dengue NS1 Ag enzyme immunoassay.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Study of Bio-Rad Laboratories Platelia Dengue NS1 Ag Assay in Blood Donors.|
- Number of blood donors with repeatedly reactive Platelia Dengue NS1 Ag test results. [ Time Frame: Two and a half years ] [ Designated as safety issue: No ]Platelia Dengue NS1 Ag test results on blood donors at the specified locations will be recorded and reported. Any donation with a reactive or Not Tested result will be placed on Hold until it is confirmed that the region has applied the appropriate deferral assertion on the donor.
- Number of blood donors with PCR and/or TMA confirmed positive dengue test results. [ Time Frame: Two and a half years ] [ Designated as safety issue: No ]Platelia Dengue NS1 Ag test results on retrieved plasma units of repeatedly reactive blood donor samples will be recorded, also confirmatory testing (PCR and /or TMA test results) for these blood donors samples will be recorded and reported.
Biospecimen Retention: Samples With DNA
EDTA plasma samples contained in plasma preparation tubes (PPTs) that have been frozen within 24 hours of collection and following centrifugation (under the same centrifugation conditions as used for PPTs used for nucleic acid testing, NAT) will be the primary samples for prospective testing.
|Study Start Date:||March 2010|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Device: Bio-Rad Platelia Dengue NS1 Ag test
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 13th 2010 federal officials reported an outbreak of dengue fever in Florida after a survey of Key West residents found that at least 5% had been infected or exposed to the virus. Therefore this IND study is being carried out to identify blood donors carrying the dengue virus using the Platelia Dengue NS1 Ag (Bio-Rad, France). Prospective testing is being performed on blood donors who have read an information sheet regarding the use of donated blood samples in research. Testing will occur at the American Red Cross, Charlotte, NC NTL site.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226173
|United States, Florida|
|Community Blood Centers of Florida, Inc.|
|Lauderhill, Florida, United States, 33313|
|American Red Cross|
|San Juan, Puerto Rico, 00936|
|Principal Investigator:||Susan Stramer, PhD||American Red Cross|