xTAG^® Respiratory Viral Panel (RVP) Products

xTAG RVP Products Overview

RVP FAST Receives FDA Clearance

xTAG RVP FAST receives FDA clearance for detection of 8 viruses and subtypes: Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza B, Respiratory Syncytial Virus (RSV), Human Metapneumovirus (hMPV), Rhinovirus, and Adenovirus.

Luminex pioneers in the field of multiplex testing for respiratory viruses with its esteemed product portfolio of xTAG RVPv1 and xTAG RVP FAST assays.

xTAG RVPv1 was awarded the “Best Medical Technology” Prix Galien award for 2010.

Both xTAG RVPv1 and xTAG RVP FAST are qualitative nucleic acid multiplex tests intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections. These assays use the proprietary Luminex xTAG Technology and xMAP^® Technology platform to detect multiple targets in a single sample.

Why Test for Respiratory Viruses?

In clinical setting there are over a dozen respiratory pathogens (viral and bacterial) that are commonly encountered. A clinician needs to know which of these 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 under recognized 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.

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

xTAG RVP Products Description

The xTAG RVP FAST assay is designed on the versatile Luminex^® 100/200™ platform and provides comprehensive detection of 8 viruses and subtypes: Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza B, Respiratory Syncytial Virus (RSV), Human Metapneumovirus (hMVP), Rhinovirus, and Adenovirus. With reduced hands on time and faster workflow, RVP FAST allows you to perform front-line respiratory testing which is more comprehensive than most PCR based front-line tests.

Both xTAG RVPv1 and xTAG RVP FAST include two controls (MS-2 and Lambda DNA) that help users troubleshoot and assess assay performance.

The following table highlights the various targets detect by respiratory viral panel based on its regional regulatory clearances.

Advantages of xTAG RVP

Comprehensive

• Tests for all major respiratory viruses commonly tested including Flu A subtypes (H1 and H3) in a single assay
• Assay detects and identifies multiple pathogens in a single sample providing broadest coverage for patient management and surveillance purposes.

Reliable

• With both CE and US IVD clearances the assay exhibits excellent clinical sensitivity and specificity and high reproducibility
• Make impactful clinical decisions by reliably determining whether a respiratory infection is viral or bacterial and eliminating guess work

Fast

• Provide results in a single working day (Up to 96 results in 8 hours)
• Rapid enough to impact patient treatment decisions 

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

How xTAG RVP Products Work

xTAG RVP Demonstration Video

xTAG RVP and xTAG RVP FAST Assays have a simple workflow that makes it easy to implement. Highlighted below are key steps illustrating how the assay is performed from sample collection to generating accurate results quickly and easily.

A doctor takes a sample containing viruses from a patient's nasal cavity, throat, sinuses or bronchi. 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 (Luminex^® 100/200^™) 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 data analysis software as a positive.


The Luminex 100/200 is a Class 1 (I) laser product.

xTAG RVP and xTAG RVP FAST come with easy to interpret data analysis software, which provide clear results at a glance. Further detail on results such as the strength of the signals is available at the click of a button. 

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

Downloads

Document	Language	Type	Download
MSDS
MSDS (click to search database)
Brochure
RVP FAST Brochure	English	pdf
Posters and Research
RVP FAST Poster	English	pdf
Children's Mercy Hospitals and Clinics	English	pdf
Dallas Children's Hospital	English	pdf
London Health Science Center	English	pdf
North Shore University Hospital	English	pdf
St. Joseph's Hospital 1	English	pdf
St. Joseph's Hospital 2	English	pdf
The Children's Hospital Denver	English	pdf
Virginia Commonwealth University	English	pdf
Evaluation of RVP FASTv2 on MAGPIX and performance on EQA panels	English	pdf
Evaluation of xTAG® RVP FASTv2 in Spain	English	pdf
Detection of respiratory viruses over 6-month period using RVP FAST in French pediatric hospital	English	pdf

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

xTAG RVP Training Courses

At Luminex Learning, we offer online, live online, and classroom training options. To view a list of our course offerings, or to enroll in a course, please visit our training page.

P.A.C.E.^® Accredited Webcast

Improving Clinical and Therapeutic Outcomes for Respiratory Viral Infection using Multiplex PCR

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

Support Information

Luminex offers comprehensive technical support enabling companies and laboratories to perform clinical diagnosis quickly, accurately, and cost effectively while optimizing the customer experience with Luminex assays and systems.

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

Ordering Information

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.