Collection and Testing of Respiratory Samples

NCT01302418 | Completed Results

• 1 other identifier: C10-INFLUENZA-001
• Study Type: observational
• Target: 272
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Respiratory Virus; Influenza; RSV; Parainfluenza; Metapneumovirus; Rhinovirus; Coxsackie virus; Echo virus; Adenovirus; Coronavirus; Bocavirus

Outcome Measures

Primary Outcomes (1)

• Detection of Respiratory Viruses

  The presence of Influenza A or Influenza B virus.

  Specimens will be taken within 5 days of the appearance of symptoms.

Study Arms (1)

Symptomatic

Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.

Device: artus Influenza A/B RT-PCR Test

Interventions

artus Influenza A/B RT-PCR Test DEVICE

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

Symptomatic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes individuals having the signs and symptoms of an acute respiratory tract infection suspected of being caused by a respiratory virus.

You may qualify if:

• Subjects that sign the Informed Consent form required for prospectively enrolling patients into the study.
• Subjects that present at a hospital, clinic, or physician's office with the signs and symptoms of a respiratory tract infection.
• Subjects with an acute respiratory infection where said acute respiratory infection is suspected of being caused by an Influenza virus.

You may not qualify if:

• Subjects where the duration of the symptoms of such an acute respiratory infection is greater than or equal to 5 days (i.e., ≥5).

Sponsors & Collaborators

• QIAGEN Gaithersburg, Inc: lead

Study Sites (5)

University of Arizona

Tuscon, Arizona, 85719, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Wadsworth Center, New York State Department of Health

Albany, New York, 12208, United States

Location

The University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Extracted nucleic acid, Residual Universal Transport Medium

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Coxsackievirus Infections; Influenza, Human; Paramyxoviridae Infections; Adenoviridae Infections; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; Respiratory Tract Infections; Orthomyxoviridae Infections; Respiratory Tract Diseases; DNA Virus Infections; Coronaviridae Infections; Nidovirales Infections

Results Point of Contact

• Title: Tony Lam
• Organization: QIAGEN

tony.lam@qiagen.com

301-944-7090

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 24, 2011
• Study Start: February 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 10, 2017
• Results First Posted: June 28, 2012

Record last verified: 2017-04

Locations

US (5)