Dengue Virus NS1 Antigen (Bio-Rad) Clinical Protocol

This study has been completed.
Sponsor:
Collaborators:
American National Red Cross
Information provided by (Responsible Party):
Bio-Rad Laboratories
ClinicalTrials.gov Identifier:
NCT01226173
First received: October 19, 2010
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Mass Screening
Device: Bio-Rad Platelia Dengue NS1 Ag test

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Bio-Rad Laboratories Platelia Dengue NS1 Ag Assay in Blood Donors.

Resource links provided by NLM:


Further study details as provided by Bio-Rad Laboratories:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 182353
Study Start Date: March 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The initiation of the dengue NS1 Ag IND study began on March 8th, 2010 with a study population of donations collected by the American Red Cross in Puerto Rico and the study population was expanded to Monroe County blood collections of the Community Blood Centers of Florida, Inc in August 2010. Testing of collections may be further expanded to include other non-ARC sites in Puerto Rico, or to sites in the continental US with documented local dengue virus transmission. Testing may also include retrospective testing of a repository of samples retained from Puerto Rico during the 2009 epidemic season.Testing will be performed from donors who have read information sheets specific to this study (Dengue Research Study Donor Information).

Criteria

Inclusion Criteria:

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 Criteria:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226173

Locations
United States, Florida
Community Blood Centers of Florida, Inc.
Lauderhill, Florida, United States, 33313
Puerto Rico
American Red Cross
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Bio-Rad Laboratories
American National Red Cross
Investigators
Principal Investigator: Susan Stramer, PhD American Red Cross
  More Information

Publications:
Responsible Party: Bio-Rad Laboratories
ClinicalTrials.gov Identifier: NCT01226173     History of Changes
Other Study ID Numbers: ARC IRB Protocol # 2009-037, 1RC2HL101632-01
Study First Received: October 19, 2010
Last Updated: September 20, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Bio-Rad Laboratories:
Prospective screening of blood donors.

ClinicalTrials.gov processed this record on September 22, 2014