xTAG Respiratory Viral Panel

Product Description
Design
Supporting Information
Ordering Info

xTAG RVP Benefits

Tests for multiple different viruses and subtypes
The only CE Mark respiratory test that identifies all of the major respiratory viruses commonly screened for in surveillance and patient management.

Eliminates guesswork
Aids in determining whether a respiratory infection is viral or bacterial.

Rapid
Provides results in a single shift, fast enough to be of clinical value.

Cost-effective
Information on multiple viral targets at one low price.

Robust
Detect and identify multiple pathogens in a sample.

About xTAG Respiratory Viral Panel
The xTAG™ Respiratory Viral Panel (RVP) is a diagnostic test for the detection of multiple viral strains and subtypes. The test was designed to allow better decision-making in patient management and to limit the spread of infection, and therefore has value in both clinical settings and as a surveillance tool.

xTAG RVP was developed using Luminex Molecular Diagnostics Universal Array — a proprietary solution-based microarray capable of combining any set of 100 single DNA tests and performing them simultaneously in a single reaction, which operates on the Luminex xMAP® system, a well-established bioassay detection platform that uses lasers to read color-coded microspheres that attach to specific nucleic acid sequences.


Influenza	Influenza A (Non-specific)
	H1
	H3
	H5
	Influenza B
Respiratory Syncytial Virus (RSV)	A
	B
Corona Virus	NL 63
	229E
	OC43
	HKU1
	SARS
ParaInfluenza	1
	2
	3
	4
Adenovirus
Metapneumovirus
Rhinovirus/Enterovirus

A doctor collects a sample, containing virus, from the patient. Nucleic acid is extracted from viruses found in the sample. Most respiratory viruses are based on unstable RNA and are converted to complimentary DNA (cDNA) for testing due to DNA's better stability.

The nucleic acid is amplified using polymerase chain reaction (PCR), a molecular biology technique for rapidly creating multiple copies of DNA.

The amplified DNA is mixed with short sequences (TAG primers) of DNA specific to each viral target. If the target is present, the primer will bind and will be lengthened through a process called Target Specific Primer Extension. During this extension, a label is incorporated.

Color-coded beads are added to identify the tagged primers. Attached to each differently colored bead is an anti-TAG sequence specific to one of the extended TAG primers. Each anti-TAG only binds to the complementary TAG sequence on the primer.

Samples are then placed in a Luminex xMAP® instrument where beads are read and analyzed by lasers. The lasers identify the color of the bead (specific to a virus or subtype) and the presence or absence of the labeled primer. If a particular virus is present, it will generate a signal and will be identified by the associated software as a positive.

xTAG RVP comes with easy to interpret data analysis software, which provides clear results at a glance. Further detail on results such as the strength of the signals is available at the click of a button. (Image shows CE Marked version of software.)

Why Test for Respiratory Issues?
In clinical settings there are over a dozen respiratory pathogens (viral and bacterial) that are commonly encountered. A clinician needs to know which of these are, or are not infecting a patient in order to effectively prescribe treatment (such as knowing when an antiviral or an antibiotic is likely to be effective), and to control the spread of infection.

Unfortunately, determining the source of a respiratory infection using traditional methods can be challenging and as a result, rather than using a diagnostic test, many physicians send patients with flu-like symptoms home without treatment or else treat them with the wrong medications.

It is not surprising then that a recent New England Journal of Medicine study of children with influenza showed that only 28% of hospitalized and 17% of outpatient children were accurately diagnosed by their physician.(1)

The Centers for Disease Control (CDC) states that viral infections are a major cause of hospitalizations in young children and the elderly, and represent the seventh leading cause of death in the United States(2) with annual direct and indirect costs estimated at more than US$10 billion per year.(3) From influenza alone, every year over two hundred thousand Americans are hospitalized and 36 thousand of them die from their infection.(4)

Given the consequences, early detection is critically important both to improve individual patient outcomes and to prevent the spread of disease. Rapid testing for respiratory viruses, if established as the standard of care, could substantially lower health care costs and potentially save lives.

1. Poehling, K. A., K. M. Edwards, et al. (2006). "The underrecognized burden of influenza in young children." N Engl J Med 355(1): 31-40.
2, 4. Centers for Disease Control. About the Flu; Influenza: The Disease. November, 2004. http://www.cdc.gov/flu/about/disease.htm. Accessed June 2006.
3. White House Government National Strategy for Pandemic Influenza.

Interviews

Burden of Illness of Respiratory Viruses
James Mahony, McMaster University - November 9, 2006

Webcasts

Methodology for Detection of Viral Respiratory Pathogens
Steven B. Kleiboker, PhD
Viral Diagnosis in Pediatric Patients
Peter Wright, MD
Respiratory Viruses in the Immunocompromised: Diagnosis and Management
Michael G. Ison, MD MS

Posters and Research

Children's Mercy Hospitals and Clinics (pdf)
Dallas Children's Hospital (pdf)
London Health Science Center (pdf)
North Shore University Hospital (pdf)
St. Joseph's Hospital 1 (pdf)
St. Joseph's Hospital 2 (pdf)
The Children's Hospital Denver (pdf)
Virginia Commonwealth University (pdf)

Order Information

Product Name	Package Size	Vysis^® Order Number	Abbott Order Number
xTAG Respiratory Viral Panel (RVP) - CE Mark	96 tests	03N30-03	03N30-03 3N30

For In Vitro Diagnostic Use.

CE Marked