Collection and Extraction of Respiratory Specimens
The study will be conducted with nasopharyngeal swab specimens collected prospectively from individuals suspected of having an acute respiratory tract infection caused by an Influenza virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, as well as the CDC swine H1N1 test will be used to establish a collection of well characterized specimens. For each specimen four (4) aliquots will be prepared. One aliquot will be tested in real-time using the requisite viral culture reference methods, one aliquot will be used for H1N1 reference testing, one aliquot will be used to extract nucleic acid in real-time, and one aliquot of the UTM will be archived for the purpose of sequencing to confirm Influenza-positive specimens. The extracted nucleic acid and any remaining specimen will be stored at -70°C for later testing by the artus Influenza RG PCR test, or other investigational method(s).
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Collection & Extraction of Respiratory Specimens for the Validation of the Artus Influenza RG PCR Test|
- Presence of Influenza Virus [ Time Frame: Specimens will be taken within 7 days of the appearance of symptoms. ] [ Designated as safety issue: No ]To confirm the presence of Influenza virus in nasopharyngeal specimens taken from individuals having influenza like symptoms.
Biospecimen Retention: Samples With DNA
Extracted nucleic acid, Residual Universal Transport Medium.
|Study Start Date:||March 2010|
|Study Completion Date:||June 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Individuals with signs and symptoms of a respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
Each year the morbidity and mortality associated with respiratory tract infections fluctuates seasonally. This rise and fall is associated with the changing prevalence of respiratory viruses in the population. Myriad respiratory viruses are responsible for these infections. For example, Influenza Virus, Respiratory Syncytial Virus (RSV), Parainfluenza Virus, Human Metapneumovirus, Rhinovirus, and Adenovirus have all been identified as causing such infections. Numerous pathogenic subtypes have been identified within most of these viral groups. Apart from supportive measure (e.g., bed rest, hydration, etc.), there are no effective treatments for these viral infections; however, antiviral agents (e.g.,Tamiflu) can be used to alleviate the severity of flu-like symptoms.
Each year the virus population fluctuates, and with it the antigenic presentation of the dominant strains that circulate through the population. Epidemics arise when larger and larger portions of the population do not have innate or acquired resistance to such strain(s) in a given season. The World Health Organization (WHO) maintains a separate website dedicated to tracking outbreaks of influenza, especially avian influenza (https://www.who.int/fluvirus_tracker). Influenza outbreaks monitored in the hope that a pandemic similar to the Spanish Flu of 1918 can be avoided; it is estimated that well over 25 million people died from the Spanish Flu. The United States government also maintains a separate website with resources regarding the flu and pandemic related information (http://www.pandemicflu.gov/). On June 11, 2009 the WHO raised the pandemic threat level to 6 in response to the global appearance of a new strain of swine Influenza A (subtype H1N1). The rapidity with which the H1N1 virus has spread exemplifies the notion that quickly and accurately identifying a viruses associated with an outbreak is critical to global public health.
In the present study a collection of respiratory specimens that are well characterized will be archived for later evaluation using the artus® Influenza RG PCR test. The artus Influenza test is a real-time PCR test that identifies Influenza A, Influenza B, and Influenza Type A/subtype H1N1 from nasopharyngeal swab specimens.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083511
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States, 85719|
|United States, North Carolina|
|The University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|