Mass ScreeningNCT01226173
Dengue Virus NS1 Antigen (Bio-Rad) Clinical Protocol
An observational study of Mass Screening, run by Bio-Rad Laboratories at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mass Screening
- What is being tested?
- Bio-Rad Platelia Dengue NS1 Ag test
- Type of treatment
- Medical device
- How many people
- 182,353 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2010to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Community Blood Centers of Florida, Inc.
Lauderhill, Florida, 33313
About this study
Official title: Study of Bio-Rad Laboratories Platelia Dengue NS1 Ag Assay in Blood Donors.
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.
Read the 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
- Being tested
- Bio-Rad Platelia Dengue NS1 Ag test
- Keywords
- Prospective screening of blood donors.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-Rad Platelia Dengue NS1 Ag testDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of blood donors with repeatedly reactive Platelia Dengue NS1 Ag test results.
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.
Measured: Two and a half years
Secondary outcomes (1)
Number of blood donors with PCR and/or TMA confirmed positive dengue test results.
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.
Measured: Two and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mass ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 182,353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Rad Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American National Red Cross, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Susan Stramer, PhD, Principal investigator, American National Red Cross
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226173
- Sponsor's protocol ID
- ARC IRB Protocol # 2009-037
- Other IDs
- 1RC2HL101632-01
- Status last verified
- Sep 2012
- First submitted
- 19 Oct 2010
- Last updated
- 24 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16988003Bessoff 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.
PubMed 20410325Kumarasamy 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.
PubMed 17609831Alcon 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.
PubMed 11825945
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Bio-Rad Laboratories Platelia Dengue NS1 Ag Assay in Blood Donors.
- ClinicalTrials.gov ID
- NCT01226173
- Acronym / sponsor ID
- ARC IRB Protocol # 2009-037
- Conditions
- Mass Screening
- Keywords
- Prospective screening of blood donors.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182,353 participants (actual)
- Lead sponsor
- Bio-Rad LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- American National Red Cross, Centers for Disease Control and Prevention
- Study start
- Mar 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-Rad Platelia Dengue NS1 Ag testThe 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. | Device | – |
Primary outcome
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.
1 secondary outcome
Number of blood donors with PCR and/or TMA confirmed positive dengue test results.
Time frame: Two and a half years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
- Background: PubMed 16988003Dussart 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.
- Background: PubMed 20410325Bessoff 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.
- Background: PubMed 17609831Kumarasamy 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.
- Background: PubMed 11825945Alcon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Stramer, PhD principal investigator
American National Red Cross
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mass Screening, run by Bio-Rad Laboratories at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of blood donors with repeatedly reactive Platelia Dengue NS1 Ag test results. (time frame: Two and a half years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01226173, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.