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Dengue Virus NS1 Antigen (Bio-Rad) Clinical Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01226173
Recruitment Status : Completed
First Posted : October 22, 2010
Last Update Posted : September 24, 2012
Sponsor:
Collaborators:
American National Red Cross
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Bio-Rad Laboratories

Study Description
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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 Dengue NS1 Ag enzyme immunoassay.

Condition or disease Intervention/treatment
Mass Screening Device: 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.
Study Design
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Study Type : Observational
Actual Enrollment : 182353 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Bio-Rad Laboratories Platelia Dengue NS1 Ag Assay in Blood Donors.
Study Start Date : March 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

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Groups and Cohorts
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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.

Outcome Measures
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Primary Outcome Measures :
  1. Number of blood donors with repeatedly reactive Platelia Dengue NS1 Ag test results. [ Time Frame: Two and a half years ]
    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 :
  1. Number of blood donors with PCR and/or TMA confirmed positive dengue test results. [ Time Frame: Two and a half years ]
    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.

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226173


Locations
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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
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Susan Stramer, PhD American National Red Cross
More Information
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Publications:

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Responsible Party: Bio-Rad Laboratories
ClinicalTrials.gov Identifier: NCT01226173    
Other Study ID Numbers: ARC IRB Protocol # 2009-037
1RC2HL101632-01 ( U.S. NIH Grant/Contract )
First Posted: October 22, 2010    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012
Keywords provided by Bio-Rad Laboratories:
Prospective screening of blood donors.
Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Vector Borne Diseases
Infections
Virus Diseases
 Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral