Study Results
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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COMPLETED
97 participants
OBSERVATIONAL
2018-07-26
2018-10-18
Brief Summary
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Detailed Description
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Collection sites will consent patients and collect one (1) 4 mL whole blood sample from adults and either (1) 2 mL pediatric whole blood sample or 0.5 mL whole blood sample collected in a micro collection container from pediatric patients (anticoagulant: K2EDTA or defined alternative) from each patient enrolled into the study. Patients may not be enrolled in the study more than once. Patients considered for enrollment will be logged on an enrollment log. Log must be reviewed by the site prior to considering a patient for study enrollment to confirm enrollment status. Samples collected will be de-identified and assigned a specific study number. Study numbers and labels will be provided to collection site by the study monitor.
Study site will accept or reject samples based on shipping verification procedures and then process samples acceptable for testing within 24 hours of receipt. Sample testing must be performed in accordance with the Applied Biosystems™ Bacillus anthracis Detection Kit instructions for use.
At study start, study site will test whole blood samples received from collection sites daily (e.g. Tuesday, Wednesday, Thursday, and Friday) using the Applied Biosystems™ Bacillus anthracis Detection Kit. No reference testing will be required since the study is designed only to demonstrate product specificity. Samples are assumed to be negative for Bacillus anthracis. A minimum of 50, but likely 100 febrile whole blood samples will be tested at MRIGlobal.
Data generated will demonstrate product specificity when testing febrile whole blood samples.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Data Collection
TaqMan Bacillus anthracis Detection Kit
The TaqMan® Bacillus anthracis Detection Kit is composed of the Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software, secondary interpretative software, and lyophilized reagents for the detection of gene targets for B. anthracis. The test assay is a multiplexed assay targeting gene targets for B. anthracis, in addition to an internal positive control. Reagents are lyophilized as a fully formulated Mastermix and are stable at room temperature for up to two years. The kit is specifically designed for performing real-time PCR using the Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software , with nucleic acids extracted from clinical specimens using Qiagen's QIAamp® Blood Midi Kit manual extraction or Roche MagNAPure automated extraction methods.
Interventions
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TaqMan Bacillus anthracis Detection Kit
The TaqMan® Bacillus anthracis Detection Kit is composed of the Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software, secondary interpretative software, and lyophilized reagents for the detection of gene targets for B. anthracis. The test assay is a multiplexed assay targeting gene targets for B. anthracis, in addition to an internal positive control. Reagents are lyophilized as a fully formulated Mastermix and are stable at room temperature for up to two years. The kit is specifically designed for performing real-time PCR using the Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software , with nucleic acids extracted from clinical specimens using Qiagen's QIAamp® Blood Midi Kit manual extraction or Roche MagNAPure automated extraction methods.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2 Years
89 Years
ALL
No
Sponsors
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Department of Health and Human Services
FED
MRI Global
INDUSTRY
Responsible Party
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Locations
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Boca Biolistics
Tarpon Springs, Florida, United States
New England Center for Clinical Research
Fall River, Massachusetts, United States
Medical Research Network
Franklin, Massachusetts, United States
Countries
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Other Identifiers
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MRI-2017-004/5
Identifier Type: -
Identifier Source: org_study_id