NCT01226173

Dengue Virus NS1 Antigen (Bio-Rad) Clinical Protocol

Study of Bio-Rad Laboratories Platelia Dengue NS1 Ag Assay in Blood Donors.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 182,353 (actual)
• Sponsor: Bio-Rad Laboratories · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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 Dengue NS1 Ag enzyme immunoassay.

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 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.

Conditions

• Mass Screening

Interventions

Type	Name	Description
DEVICE	Bio-Rad Platelia Dengue NS1 Ag test	The purpose of the study is to screen blood donors for the presence of dengue NS1 antigen at the ARC in Puerto Rico region using the Bio-Rad Platelia Dengue NS1 Ag test.

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-10-22
• Last updated: 2012-09-24

Locations

2 sites across 2 countries: United States, Puerto Rico