Clinical Trial Sponsors: QIAGEN Gaithersburg, Inc

  Source:		NCT01302418

    		Collection and Testing of Respiratory Samples

			First Update February 18, 2011
			Last Update April 3, 2017

			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 Description
			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 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).
			These zoonotic transmissions that further
			adapt to enable human-to-human transmission
			are of the greatest concern because it is
			predicted that virtually all humans will be
			immunologically naïve. Zoonotic transmissions
			in the human population are 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 viral
			pathogen associated with an outbreak is critical
			to global public health. In addition to the threat
			of an influenza outbreak, the expansion in the
			number of viruses that cause acute respiratory
			tract infections compounds the difficulty in
			correctly and rapidly identifying the primary
			pathogen; each new virus or subtype increases
			the complexity of testing. Molecular diagnostic
			assays are ideally suited to address this
			complexity. Assays based on the polymerase
			chain reaction (PCR) can incorporate multiple
			primers and probes (e.g., multiplexed) in a
			single reaction to deal with this complexity.4
			Such assays are extremely sensitive, have a
			high degree of specificity, and can be performed
			very quickly. The artus Influenza A/B RT-PCR
			test is a real-time PCR assay for the detection
			and identification of Influenza A and B, while
			the QIAGEN ResPlex II Advanced Panel test
			is a nucleic acid amplification-based assay for
			the detection and identification of a broad
			range of some of the most common respiratory
			viruses associated with acute respiratory tract
			infections. In the present study respiratory
			specimens will be prospectively collected and
			tested using the artus Influenza A/B RT-PCR
			test and the QIAGEN ResPlex II Advanced
			Panel test.

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