Interpretive Data

LIMITATIONS:

1. These results are not intended to be used as the sole basis for diagnosis, treatment, or patient management decisions.
2. The performance of this test has not been established for immunocompromised patients.
3. Thie performance of this test has not been established for patients without signs and symptoms of respiratory infection.
4. Positive results do not rule out co-infection with organisms not included in the panel. The agent detected may not be the definitive cause of disease.
5. Negative results do not preclude infection of the upper respiratory tract. Not all agents of acute respiratory infection are detected by this assay and sensitivity in some clinical settings may differ from what is described in the IFU.
6. A negative result with this panel does not exclude the infectious nature of the syndrome. Negative assay results may originate from several factors and their combinations, including handling errors, variations in nucleic acid sequences targeted by the assay, infection by organisms not included on the panel, organism levels of panel targets at a concentration below the LoD, or the use of certain medications, therapies or agents.
7. All assay results should be used and interpreted by a trained healthcare professional in the context of a full examination, laboratory and epidemiological findings, as an aid in the diagnosis of respiratory infection.
8. This test should be used in conjunction with standard of care culture for organism recovery, serotyping, and/or AST when applicable.
9. This is a qualitative test and does not provide the quantitative value of detected organisms.
10. Viral and bacterial nucleic acids may persist in vivo, even if the organism is not viable or infectious. Detection of a target marker does not imply that the corresponding organism is the causative agent of the infection or clinical symptoms.
11. Detection of viral and bacterial nucleic acids depends on proper collection, handling, storage, and testing. Improper practices for any of these processes can cause incorrect results, including false-positive or false-negative results.
12. The performance of this test has not been established for individuals who have received Influenza vaccine. Recent administration of nasal Influenza vaccine may case false positive results for Influenza A and/or Influenza B.
13. This panel may not be able to distinguish between existing viral strains and new variants as they emerge. For example, this assay can detect H3N2 Influenza but may not be able to distinguish H3N2 from H2N2 variant (H3N2v).
14. This panel detects the multi-copy IS481 insertion sequence present in multiple Bordatella species. False positive B. pertussis results are possible if the specimen is contaminated with non-pertussis Bordatella species.
15. The assay sensitivity and specificity, for the specific organisms and for all organisms combined, are intrinsic performance parameters of a given assay and do not vary depending on prevalence. In contrast, both the negative and positive predictive values of a test result are dependent on the disease/organism prevalence. False negative test results are more likely during peak activity when disease prevalence is high. False positive test results are more likely during periods when prevalence is moderate or low.
16. If infection with novel Influenza A 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 public health lab for testing. Do not attempt viral culture on these specimens.
17. Clinical performance has not been established with all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains and their prevalence, which change over time.
18. Performance characteristics for Influenza A were established when Influenza A/H3 and Influenza A/H1-2009 were the predominant strains.
19. This test has been evaluated with human specimen material only.
20. This test has not been validated for testing pooled specimens.
21. The performance of this test has not been established for monitoring treatment of infection with any of the panel organisms.
22. The Influenza A/H1 and A/H3 subtyping assays target the Influenza A hemagglutinin (H) gene only; it does not detect or differentiate the Influenza A/H1 and A/H3 neuraminidase (N) subtypes.
23. The Influenza A/H1N1 pdm09 subtyping assay targets the Influenza A neuraminidase (N) gene only; it does not detect of differentiate the Influenza A/H1N1 pdm09 hemagglutinin (H) subtype.
24. Due to the genetic similarity between Human Rhinovirus and Enterovirus, this panel cannot differentiate between them. A Detected result for this target should be followed by testing using an alternate method if differentiation is necessary.
25. If a specimen yields a repeated positive result for Influenza A but produces negative tests for all specific Influenza A subtypes (i.e., H1, H1N1pdm09, or H3), it may be appropriate to have the specimen forwarded to a public health lab for further analysis.
26. Due to the small number of positive specimens collected during prospective and retrospective studies, performance characteristics for Influenza A H1 and Parainfluenza virus 2 were established mainly using contrived specimens.
27. In silico analysis of the SARS-CoV-2 primer/probe sequences indicated that they may cross react with pangolin and bat coronaviruses, causing false positive results. Pangolin and bat coronaviruses are not currently known to circulate in the human population, and this cross reactivity is determined to be of low-risk.