Clinical Trial: Collection and Testing of Respiratory Samples

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Testing of Respiratory Specimens for the Validation of the QIAGEN ResPlex II Advanced Panel Test and the Artus Influenza A/B RT-PCR Test

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.

Detailed Summary:

Each year the morbidity and mortality associated with acute 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 acute infections. Numerous pathogenic subtypes have been identified within most of these viral groups. The outbreak of Severe Acute Respiratory Syndrome (SARS) in 2003 was eventually identified as a Coronavirus; the mortality of SARS among the elderly can be as high as 50%. More recently, Human Bocavirus (HBoV) has also been identified as causing acute respiratory tract infections. In 2005 the HBoV was identified by molecular testing and was found to be the only virus identified in a subpopulation of patients suffering from respiratory tract infections. Apart from supportive measure (e.g., bed rest, hydration, etc.), there are no effective treatments for many of these viral infections; however, antiviral agents (e.g., the neuraminidase inhibitors oseltamivir or zanamivir) can be used to alleviate the severity of flu-like symptoms. Identification of a respiratory virus as the causative agent is important because it eliminates the need for treatment with antibiotics; physicians typically wait 7-10 days for symptoms to alleviate before prescribing antibiotics due to risks associated with exacerbating bacterial antibiotic resistance.

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 immunological resistance to such strain(s) in a given se
Sponsor: QIAGEN Gaithersburg, Inc

Current Primary Outcome: Detection of Respiratory Viruses [ Time Frame: Specimens will be taken within 5 days of the appearance of symptoms. ]

The presence of Influenza A or Influenza B virus.


Original Primary Outcome: Detection of Respiratory Viruses [ Time Frame: Specimens will be taken within 5 days of the appearance of symptoms. ]

QIAGEN ResPlex II Advanced Panel are:

  1. To establish that the clinical sensitivity and specificity are substantially equivalent to viral culture
  2. To establish that the clinical sensitivity and specificity are substantially equivalent to the respective validated nucleic acid amplification-based (i.e., PCR) laboratory developed test (PCR-LDT)

artus Influenza A/B RT-PCR Test is:

1.To establish that the clinical sensitivity and specificity are substantially equivalent to standard viral culture



Current Secondary Outcome:

Original Secondary Outcome:

Information By: QIAGEN Gaithersburg, Inc

Dates:
Date Received: February 18, 2011
Date Started: February 2011
Date Completion:
Last Updated: April 3, 2017
Last Verified: April 2017