xTAG^® RVP FAST

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

1. 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.
2. 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.
3. 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.
4. 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).
5. 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.
6. 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.
7. There is a risk of false negative values resulting from improperly collected, transported, or handled specimens.
8. 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.
9. The performance of the assay has not been established in individuals who received nasally administered Influenza A vaccine.
10. RVP performance was not established in immunocompromised patients.
11. 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