Febrile Whole Blood Specimen Collection and Testing
Condition: Febrile Infection; Anthrax
MeSH terms: Anthrax; Hyperthermia; Fever
Study type: Observational

Summary: 
      Whole blood samples will be collected from febrile patients presenting with fever of unknown
      origin and flu-like syndromes. 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 from
      each patient enrolled into the study. Study site will test whole blood samples received from
      collection sites daily using the Applied Biosystems™ Bacillus anthracis Detection Kit. Data
      generated will demonstrate product specificity when testing febrile whole blood samples.
    

Detailed description: 
      Whole blood samples will be collected from febrile patients presenting with fever of unknown
      origin and flu-like syndromes. Collection sites will be advised of collection requirements
      specific to patient population with the goal of collecting samples form patient between the
      ages of 2-89 years of age. 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. Samples must be shipped to MRIGlobal or designated study site on the day of
      collection.

      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.
    

Intervention name(s): TaqMan Bacillus anthracis Detection Kit
Intervention type(s): Device
Intervention description(s): 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.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inclusion criteria to be documented on data form provided.

          -  Fever of unknown origin

          -  Flu like syndrome

        Age ranges of study participants is as follows:

        2-15 Years of age 15-21 Years of age 22-40 Years of age >40 Years of age
      
Biospecimen description: 
      Febrile Whole Blood