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Dengue Virus NS1 Antigen (Bio-Rad) Clinical Protocol

NCT ID: NCT01226173

Last Updated: 2012-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

182353 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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

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Mass Screening

Keywords

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Prospective screening of blood donors.

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American National Red Cross

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Bio-Rad Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Stramer, PhD

Role: PRINCIPAL_INVESTIGATOR

American National Red Cross

Locations

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Community Blood Centers of Florida, Inc.

Lauderhill, Florida, United States

Site Status

American Red Cross

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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Dussart P, Labeau B, Lagathu G, Louis P, Nunes MR, Rodrigues SG, Storck-Herrmann C, Cesaire R, Morvan J, Flamand M, Baril L. Evaluation of an enzyme immunoassay for detection of dengue virus NS1 antigen in human serum. Clin Vaccine Immunol. 2006 Nov;13(11):1185-9. doi: 10.1128/CVI.00229-06. Epub 2006 Sep 20.

Reference Type BACKGROUND
PMID: 16988003 (View on PubMed)

Bessoff K, Phoutrides E, Delorey M, Acosta LN, Hunsperger E. Utility of a commercial nonstructural protein 1 antigen capture kit as a dengue virus diagnostic tool. Clin Vaccine Immunol. 2010 Jun;17(6):949-53. doi: 10.1128/CVI.00041-10. Epub 2010 Apr 21.

Reference Type BACKGROUND
PMID: 20410325 (View on PubMed)

Kumarasamy V, Chua SK, Hassan Z, Wahab AH, Chem YK, Mohamad M, Chua KB. Evaluating the sensitivity of a commercial dengue NS1 antigen-capture ELISA for early diagnosis of acute dengue virus infection. Singapore Med J. 2007 Jul;48(7):669-73.

Reference Type BACKGROUND
PMID: 17609831 (View on PubMed)

Alcon S, Talarmin A, Debruyne M, Falconar A, Deubel V, Flamand M. Enzyme-linked immunosorbent assay specific to Dengue virus type 1 nonstructural protein NS1 reveals circulation of the antigen in the blood during the acute phase of disease in patients experiencing primary or secondary infections. J Clin Microbiol. 2002 Feb;40(2):376-81. doi: 10.1128/JCM.40.02.376-381.2002.

Reference Type BACKGROUND
PMID: 11825945 (View on PubMed)

Other Identifiers

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1RC2HL101632-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ARC IRB Protocol # 2009-037

Identifier Type: -

Identifier Source: org_study_id