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Collection and Testing of Respiratory Samples

NCT01302418 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 272

Last updated 2017-05-10

Study results available
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Summary

The study will be conducted using nasopharyngeal swab specimens collected prospectively from individuals suspected of having the signs and symptoms of an acute respiratory tract infection caused by a respiratory virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot will be tested in real-time using the assigned viral culture reference methods; (b) one aliquot will be used to extract nucleic acid in real-time for investigational testing; (c) one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent follow-up by the reference laboratory (e.g., bi-directional sequencing of positive specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The extracted nucleic acid generated from the second aliquot (i.e., "b" above) will be split and subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced Panel test.

Conditions

  • QIAGEN ResPlex II Advanced Panel
  • Influenza A
  • Respiratory Syncytial Virus Infections
  • Infection Due to Human Parainfluenza Virus 1
  • Parainfluenza Type 2
  • Parainfluenza Type 3
  • Parainfluenza Type 4
  • Human Metapneumovirus A/B
  • Rhinovirus
  • Coxsackie Virus/Echovirus
  • Adenovirus Types B/C/E
  • Coronavirus Subtypes 229E
  • Coronavirus Subtype NL63
  • Coronavirus Subtype OC43
  • Coronavirus Subtype HKU1
  • Human Bocavirus
  • Artus Influenza A/B RT-PCR Test
  • Influenza B

Interventions

DEVICE

artus Influenza A/B RT-PCR Test

The investigational assay, used for detecting the presence of Influenza A/B.

Sponsors & Collaborators

  • QIAGEN Gaithersburg, Inc

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-07-31
Completion
2011-11-30

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01302418 on ClinicalTrials.gov