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Influenza A and B Rapid Molecular Test
MessageMUST BE COLLECTED AT THE MAIN LAB CHOMP
Test Code
LAB924
Alias/See Also
FLUAB, FLU
CPT Codes
87502
Preferred Specimen
Nasal swab.
Use the DRY TRANSPORT SYSTEM STERILE FOAM SWAB only.
Use the DRY TRANSPORT SYSTEM STERILE FOAM SWAB only.
Instructions
- Use the Sterile Foam Swab Dry Transport System
- Carefully insert the swab into the nostril exhibiting the most visible drainage, or the nostril that is most congested if drainage is not visible.
- Using gentle rotation, push the swab until resistance is met at the level of the turbinates (less than one inch into the nostril).
- Rotate the swab several times against the nasal wall then slowly remove from the nostril.
Transport Container
Sterile Foam Swab Dry Transport System
Transport Temperature
Refrigerate upon collection, rush specimen to Microbiology Department.
Specimen Stability
- Room temperature (18-22'C) for up to two (2) hours.
- Refrigerated (2-8'C) for 24 hours from the time of collection.
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
- Visibly bloody samples.
- Specimens not collected using the Sterile Foam Swab Dry Transport System
Methodology
Isothermal nucleic acid amplification.
Setup Schedule
Daily
Report Available
- Within 24 hours
- STAT: within 1 hour of collection
Limitations
•The performance of the Alere™ i Influenza A & B was evaluated using the procedures provided in this package insert only. Modifications to these procedures may alter the performance of the test.
•Alere™ i Influenza A & B performance depends on viral RNA load and may not correlate with cell culture performed on the same specimen. Viral nucleic acid may persist in vivo, independent of virus viability. Detection of analyte target(s) does not imply the corresponding virus(es) are infectious, or are the causative agents for clinical symptoms.
•Performance of Alere™ i Influenza A & B has not been established for monitoring antiviral treatment of influenza.
•Although this test has been shown to detect A/H1N1 (pre-2009 pandemic), A/H7N9 (detected in China in 2013) and A/H3N2v viruses cultured from positive human respiratory specimens, the performance characteristics of this device with clinical specimens that are positive for the A/H1N1 (pre-2009 pandemic), A/H7N9 (detected in China in 2013) and A/H3N2v viruses have not been established.
•There is a risk of false negative results due to the presence of sequence variants in the viral targets of the assay. If the virus mutates in the target regions, influenza viruses A or B may not be detected or may be detected less efficiently. Additionally, if the sequence variant occurs in the target sequence recognized by the fluorescently-labeled molecular beacon an invalid assay may result.
•False negative results may occur if a specimen is improperly collected, transported or handled. False negative results may occur if inadequate levels of viruses are present in the specimen.
•Potential interference effects from FluMist™ have not been evaluated. Individuals who have received nasally administered influenza vaccine may test positive in commercially available influenza rapid diagnostic tests for up to three days after vaccination.
•This test is not intended to differentiate Influenza A subtypes or Influenza B lineages. If differentiation of specific influenza subtypes and strains is needed, additional testing, in consultation with state or local public health departments,
is required.
•Negative results do not preclude infection with influenza virus and should not be the sole basis of a patient treatment decision.
•Positive and negative predictive values are highly dependent on prevalence. The assay performance was established during the 2012 to 2013 influenza season. The positive and negative predictive values may vary depending on the prevalence and population tested.
•This test has not been evaluated for patients without signs and symptoms of influenza infection.
•The test is a qualitative test and does not provide the quantitative value of detected organism present.
•Cross-reactivity with respiratory tract organisms other than those tested in the Analytical Specificity Study may lead to erroneous results.
•This assay has not been evaluated for immunocompromised individuals.
•This test cannot rule out diseases caused by other bacterial or viral pathogens. The regions selected for amplification are conserved among all known Influenza A and Influenza B subtypes and strains (where sequence data is available from public databases). Laboratory testing has shown that Alere™ i Influenza A & B can readily amplify and detect H1N1 (pre-2009 pandemic), H3N2 (variant) and H7N9 (detected in China in 2013) influenza subtypes but the performance of the assay for detection of these subtypes in a clinical setting hasnot been established due to the lack of clinical samples.
•Alere™ i Influenza A & B performance depends on viral RNA load and may not correlate with cell culture performed on the same specimen. Viral nucleic acid may persist in vivo, independent of virus viability. Detection of analyte target(s) does not imply the corresponding virus(es) are infectious, or are the causative agents for clinical symptoms.
•Performance of Alere™ i Influenza A & B has not been established for monitoring antiviral treatment of influenza.
•Although this test has been shown to detect A/H1N1 (pre-2009 pandemic), A/H7N9 (detected in China in 2013) and A/H3N2v viruses cultured from positive human respiratory specimens, the performance characteristics of this device with clinical specimens that are positive for the A/H1N1 (pre-2009 pandemic), A/H7N9 (detected in China in 2013) and A/H3N2v viruses have not been established.
•There is a risk of false negative results due to the presence of sequence variants in the viral targets of the assay. If the virus mutates in the target regions, influenza viruses A or B may not be detected or may be detected less efficiently. Additionally, if the sequence variant occurs in the target sequence recognized by the fluorescently-labeled molecular beacon an invalid assay may result.
•False negative results may occur if a specimen is improperly collected, transported or handled. False negative results may occur if inadequate levels of viruses are present in the specimen.
•Potential interference effects from FluMist™ have not been evaluated. Individuals who have received nasally administered influenza vaccine may test positive in commercially available influenza rapid diagnostic tests for up to three days after vaccination.
•This test is not intended to differentiate Influenza A subtypes or Influenza B lineages. If differentiation of specific influenza subtypes and strains is needed, additional testing, in consultation with state or local public health departments,
is required.
•Negative results do not preclude infection with influenza virus and should not be the sole basis of a patient treatment decision.
•Positive and negative predictive values are highly dependent on prevalence. The assay performance was established during the 2012 to 2013 influenza season. The positive and negative predictive values may vary depending on the prevalence and population tested.
•This test has not been evaluated for patients without signs and symptoms of influenza infection.
•The test is a qualitative test and does not provide the quantitative value of detected organism present.
•Cross-reactivity with respiratory tract organisms other than those tested in the Analytical Specificity Study may lead to erroneous results.
•This assay has not been evaluated for immunocompromised individuals.
•This test cannot rule out diseases caused by other bacterial or viral pathogens. The regions selected for amplification are conserved among all known Influenza A and Influenza B subtypes and strains (where sequence data is available from public databases). Laboratory testing has shown that Alere™ i Influenza A & B can readily amplify and detect H1N1 (pre-2009 pandemic), H3N2 (variant) and H7N9 (detected in China in 2013) influenza subtypes but the performance of the assay for detection of these subtypes in a clinical setting hasnot been established due to the lack of clinical samples.
