xTAG Respiratory Viral Panel
| Product Name | Quantity | Order # | Additional Information | ||
| xTAG Respiratory Viral Panel (RVP) - IVD |
96 tests | 03N30-01 |
|
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xTAG® RVP Benefits
| Viral Family |
Viral Subtypes |
| Influenza | Influenza A (Non-specific) |
| H1 | |
| H3 | |
| Influenza B | |
| Respiratory Syncytial Virus (RSV) |
A |
| B | |
| ParaInfluenza |
1 |
| 2 |
|
| 3 | |
| Adenovirus | |
| Metapneumovirus | |
| Rhinovirus |
Tests for multiple different viruses and subtypes
The first in vitro diagnostic use viral panel that identifies all of the major respiratory viruses commonly screened for in surveillance and patient management.
Comprehensive
Tests for 12 different viruses and subtypes - covers virtually all major respiratory viruses commonly used in surveillance and clinical settings.
Rapid
Provides results in a single shift.
Cost-effective
One price for information on all viral targets.
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.
Sample collection
A doctor collects a sample, containing virus, from the patient. Nucleic acid is extracted from viruses found in the sample. Most respi ratory viruses are based on unstable RNA and are converted to complimentary DNA (cDNA) for testing due to DNA's better stability.
Sample preparation and PCR
The nucleic acid is amplified using polymerase chain reaction (PCR), a molecular biology technique for rapidly creating multiple copies of DNA.
Probe annealing
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.
Bead hybridization
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.
Detection
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.
Software analysis
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.)
The total system includes the Luminex 200 instrument, the Luminex XY plate handling platform, and the Luminex SD sheath fluid delivery system, software and PC. A professional Training Session for one person is included.
The Luminex 100/200 is a class 1 (I) laser product.
Intended Use
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 A subtype H1, Influenza A subtype H3, 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. It is recommended that specimens found to be negative for Influenza B, Respiratory Syncytial Virus subtype A and B, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3 and Adenovirus, after examination using RVP be confirmed by cell culture. Negative results do not preclude respiratory virus 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 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.
Due to seasonal prevalence, performance characteristics for Influenza A/H1 were established primarily with retrospective specimens.
The RVP assay cannot adequately detect Adenovirus species C, or serotypes 7a and 41. 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/H3 and A/H1 were the predominant Influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infections with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to a state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Package Inserts are available from Technical Service 800-553-7042.
Limitations
- A trained health care professional should interpret assay results in conjunction with the patient's medical history, clinical signs and symptoms, and the results of other diagnostic tests.
- Analyte targets (viral sequences) may persist in vivo, independent of virus viability. Detection of analyte target(s) does not imply that the corresponding virus(es) are infectious, or are the causative agents for clinical symptoms.
- The detection of viral sequences is dependent upon proper specimen collection, handling, transportation, storage and preparation (including extraction). Failure to observe proper procedures in any one of these steps can lead to incorrect results.
- The RVP primers that detect rhinovirus cross-react with enterovirus. A rhinovirus reactive result should be confirmed by an alternate method (e.g. Immunofluorescence, cell culture isolation).
- The RVP assay has limited detection of adenovirus species C (serotypes 1, 2, 5, 6), and serotypes 7A (species B) and 41 (species F). Samples containing low titres of adenovirus species C, serotypes 1, 2, 5, 6 may be called "negative" or "equivocal". If RVP does not yield a positive adenovirus call for a suspected infection by this pathogen, the sample should be re-tested for adenovirus using an independent method (e.g., cell culture).
- The performance characteristics for Influenza A/H1 were established primarily with retrospective banked specimens due to the low prevalence (8.1%) of the H1 subtype in the season clinical data was collected. Users should establish the sensitivity of Influenza A/H1 detection using fresh specimens.
- There is a risk of false positive values resulting from cross-contamination by target organisms, their nucleic acids or amplified product, or from non-specific signals in the assay.
- There is a risk of false negative values resulting from improperly collected, transported, or handled specimens.
- There is a risk of false negative results for certain co-infections: poor detection of adenovirus species C is expected in dual infections. If RSV a is present in low levels in clinical specimens, it may not be detected by RVP in the presence of a high level of adenovirus. If RSV a is present in medium levels in clinical specimens, it may not be detected by RVP in the presence of a high level of Influenza A/H1.
- The performance of the assay has not been established in individuals who received nasally administered Influenza A vaccine.
- RVP performance was not established in immunocompromised patients.
- The assay performance was established during the 2005/2006 season. The performance for some viruses (e.g. rhinovirus) and subtypes (e.g. Influenza A H1) may vary depending on the prevalence and population tested.
CAUTION: United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; use is restricted to, by, or on the order of a physician
