Dengue Virus NS1 Antigen (Bio-Rad) Clinical Protocol
Completed
Conditions studied: Mass Screening
In brief
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.
Key facts
- Study ID
- NCT01226173
- Run by
- Bio-Rad Laboratories
- People needed
- 182353
- Starts
- 2010-03-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2012-09-24
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Community Blood Centers of Florida, Inc. — Lauderhill, Florida, United States
- American Red Cross — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
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