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xTAG® Respiratory Viral Panel

Respiratory Virus Detection with xTAG® Respiratory Viral Panel

Gain confidence in your diagnosis with the comprehensive, multiplex xTAG RVP assay

Respiratory Viruses and Diagnostic Testing

 

Early and accurate detection of respiratory viruses is critical to improving patient outcomes and preventing the spread of disease. It is known that:

 

  • There are many respiratory pathogens—viral and bacterial—commonly encountered in a clinical setting
  • Many of these pathogens present with similar symptoms
  • Patients with flu-like symptoms are sometimes sent home without treatment or are treated with incorrect medications

 

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,1 with annual direct and indirect costs estimated at more than US $10 billion per year.2 From influenza alone, each year, over 200,000 Americans are hospitalized and 36,000 of them die from their infection.1 A 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, echoing the need for rapid influenza testing.3

 

Detect multiple respiratory viruses, the majority of which readily circulate among the most vulnerable populations—children, the elderly, and the immunocompromised—with xTAG® Respiratory Viral Panel (RVP).

Comprehensive

Tests for many different respiratory viruses including Flu A subtypes (H1 and H3) in a single assay

Reliable

Excellent clinical sensitivity and specificity
 

Efficient

Results available in a single working day to impact patient treatment

The Luminex Solution

 

xTAG RVP and xTAG RVP FAST v2 assays are qualitative nucleic acid multiplex tests intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids from nasopharyngeal swabs from individuals suspected of respiratory tract infections. These robust assays use the proprietary Luminex xTAG Technology and xMAP® Technology platform to detect multiple targets in a single sample, enabling more accurate and efficient patient diagnosis.

 

xTAG RVP and xTAG RVP FAST v2 include two controls (MS-2 and Lambda DNA) to ensure assay performance.

 

The following table shows clinical targets detected by each respiratory viral panel based on regional regulatory clearances.

 

Viral SubtypesRVPRVP FAST
Respiratory Syncytial Virus (RSV) 
  RSV A 
  RSV B 
Influenza A 
  Influenza A matrix
  H1 subtype
  H3 subtype
Influenza B
Parainfluenza 1 
Parainfluenza 2 
Parainfluenza 3 
Metapneumovirus (hMPV)
Adenovirus
Entero-Rhinovirus (Reported as Rhinovirus only in US.)
Controls
xTAG MS-2 Bacteriophage Internal Control
xTAG bacteriophage Lambda DNA Control
Viral SubtypesRVPRVP FASTRVP FAST v2
Respiratory Syncytial Virus (RSV) 
  RSV A  
  RSV B  
Influenza A 
  Influenza A matrix 
  H1 subtype
  H3 subtype
  2009 H1N1
Influenza B
Parainfluenza 1
Parainfluenza 2
Parainfluenza 3
Parainfluenza 4
Metapneumovirus (hMPV)
Adenovirus
Entero-Rhinovirus (Reported as Rhinovirus only in US.)
Corona NL63
Corona HKU1
Corona 229E
Corona OC43
Bocavirus 
Controls
xTAG MS-2 Bacteriophage Internal Control
xTAG bacteriophage Lambda DNA Control

Workflow

 

 xTAG Respiratory Viral PanelxTAG Respiratory Viral Panel FAST/FAST v2
Sample Collection and cDNA SynthesisA doctor takes a sample containing viruses from a patient. Viral nucleic acid is extracted from the sample. To increase assay stability, RNA is converted to complementary DNA (cDNA) for testing.
Step 1Step 1
AmplificationThe nucleic acid is amplified using polymerase chain reaction (PCR), a molecular biology technique for rapidly creating multiple copies of DNA.The nucleic acid is amplified using polymerase chain reaction (PCR), a molecular biology technique for rapidly creating multiple copies of DNA. The cDNA is mixed with target specific primers containing a unique TAG sequence. If the target is present, the primers will bind and the target will be amplified. During this process, the unique TAG sequence and a label are incorporated with the primers.
Step 2
Label IncorporationThe 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 through a biotinylated nucleotide.
Step 3Step 2
Bead HybridizationColor-coded beads with anti-TAG sequences specific to each TAG primer are added. Each anti-TAG only hybridizes with the complementary TAG sequence on the primer. A fluorescent reporter dye (SAPE) binds to the label on the target.
Step 4Step 3
Data AcquisitionSamples are then placed in a Luminex xMAP® instrument—the Luminex® 100/200™.3Samples are then placed in a Luminex xMAP instrument—the Luminex 100/200 or MAGPIX® system.
Step 5Step 4
Data AnalysisThe beads are read and analyzed. The analysis identifies the color of the bead (specific to a virus or subtype) and the presence or absence of the labeled primer. Each virus present will generate a signal and will be identified by the data analysis software as a positive.

Ordering Information

 

Luminex Online Order Management
Email:[email protected]
Phone:1.512.336.3550
Toll Free:1.866.401.5450
Fax:1.512.219.0544
Fax (Europe, Middle East, India, Asia):+31 (0)73 800 1998
Product NameKit SizeRegistration StatusPart Number
xTAG Respiratory Viral Panel
(RVP)
96 TestsUS-IVDI019C0111
xTAG Respiratory Viral Panel
(RVP)
96 TestsCA-IVDI019C0290
xTAG Respiratory Viral Panel FAST v2
(RVP FAST v2)
96 TestsCA-IVDI040C0412
  1. Centers for Disease Control. About the Flu; Influenza: The Disease. November, 2004. http://www.cdc.gov/flu/about/disease.htm. Accessed June 2006.
  2. White House Government National Strategy for Pandemic Influenza.
  3. Poehling KA, Edwards KM, et al. The under recognized burden of influenza in young children. N Engl J Med 2006; 355(1):31-40.

 

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.

*Only xTAG RVP FAST v2 can be used on our MAGPIX system.

Intended Use (US-IVD)**:

RVP: The xTAG® Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections. The following virus types and subtypes are identified using RVP: Influenza A, Influenza B, Respiratory Syncytial Virus subtype A, Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection if used in conjunction with other clinical and laboratory findings. Positive results do not rule out bacterial infection, or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. The RVP assay cannot adequately detect Adenovirus species C, or serotypes 7a and 41. It is recommended that specimens found to be negative for Adenovirus after examination using RVP be confirmed by an alternate method (e.g., FDA cleared molecular test or cell culture). The RVP primers for detection of rhinovirus cross-react with enterovirus. A rhinovirus reactive result should be confirmed by an alternate method (e.g. cell culture). Performance characteristics for Influenza A virus were established when Influenza A HA subtype H3, subtype H1 (prior to the emergence of subtype 2009 H1N1pdm), and when subtype 2009 H1N1pdm were the predominant Influenza A in circulation. When other Influenza A viruses are emerging, performance characteristics may vary.
RVP FAST: The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections. The following virus types and subtypes are identified using RVP FAST: Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza B, Respiratory Syncytial Virus, Human Metapneumovirus, Rhinovirus, and Adenovirus. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection if used in conjunction with other clinical and epidemiological information. Negative results do not preclude respiratory viral infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Positive results do not rule out bacterial infection or co-infection with other organisms. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory infection.

Intended Use (CA-IVD)**:

RVP: The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs, nasal aspirates and bronchioalveolar lavages from individuals suspected of respiratory tract infections. The virus types and subtypes detected by RVP FAST are Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza B, Respiratory Syncytial Virus, Coronavirus NL63, Coronavirus OC43, Coronavirus HKU1, Coronavirus 229E, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Parainfluenza 4, Human Metapneumovirus, Entero-Rhinovirus, Adenovirus, and Human Bocavirus. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection if used in conjunction with other clinical and laboratory findings.
RVP FAST: The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs, nasal aspirates and bronchioalveolar lavages from individuals suspected of respiratory tract infections. The virus types and subtypes detected by RVP FAST are Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza B, Respiratory Syncytial Virus, Coronavirus NL63, Coronavirus OC43, Coronavirus HKU1, Coronavirus 229E, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Parainfluenza 4, Human Metapneumovirus, Entero-Rhinovirus, Adenovirus, and Human Bocavirus. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection if used in conjunction with other clinical and laboratory findings.
RVP FAST v2: The xTAG® Respiratory Viral Panel Fast v2 (RVP FAST v2) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs, nasal aspirates and bronchioalveolar lavages from individuals suspected of respiratory tract infections. The virus types and subtypes detected by RVP FAST v2 are Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1N1, Influenza B, Respiratory Syncytial Virus, Coronavirus NL63, Coronavirus OC43, Coronavirus HKU1, Coronavirus 229E, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Parainfluenza 4, Human Metapneumovirus, Enterovirus/Rhinovirus, Adenovirus, and Human Bocavirus. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings.

**Please contact Luminex at [email protected] to obtain the complete intended uses of these products