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Febrile Whole Blood Specimen Collection and Testing

NCT03498027 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 97

Last updated 2018-12-19

No results posted yet for this study

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.

Conditions

  • Febrile Infection
  • Anthrax

Interventions

DEVICE

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.

Sponsors & Collaborators

Eligibility

Min Age
2 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-26
Primary Completion
2018-10-18
Completion
2018-10-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03498027 on ClinicalTrials.gov