Influenza A and Influenza B With Reflex to H5 Subtyping, NAA

Nasopharyngeal swab

1 swab

1 swab

Universal or Viral Transport Media (UTM or VTM)

Collect NP swab per standard techniques and immediately place swab in up to 3 mL of universal or viral transport media.

Freeze.

Improper collection; inadequate specimen; improper labeling; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen exceeding storage requirements; nasal swabs or any other upper respiratory sample other than nasopharyngeal swab in universal or viral transport media; samples submitted in non-approved transport devices

This test detects influenza A and influenza B by nucleic acid amplification. If influenza A is detected, a second test will be performed to confirm the presence of influenza A and to determine if the subtype is H5. This test should be used only for patients who meet the most current clinical and epidemiological criteria for H5-specific testing, as recommended by the U.S. Centers for Disease Control and Prevention. This test is validated for nasopharyngeal (NP) collections only and is intended to be used for patients presenting with respiratory symptoms consistent with influenza-like illness (ILI). Patients at risk for Influenza A/H5 and who have conjunctival symptoms only may not show a positive result for Influenza A/H5 using an NP swab.

This test detects influenza A, influenza B and sequences for the H5 subtype. Non-H5 subtypes will not be detected in this assay. Influenza A/H5 is currently very rarely found in humans in the U.S. Results from this test must be correlated with the clinical history, epidemiological data and other data available to the clinician evaluating the patient. Viral and bacterial nucleic acids may persist in vivo independent of organism viability. Detection of organism target(s) does not imply that the corresponding organisms are infectious or are the causative agents for clinical symptoms. The detection of viral and bacterial nucleic acid is dependent upon proper specimen collection, handling, transportation, storage and preparation. Failure to observe proper procedures in any one of these steps can lead to incorrect results. There is a risk of false positive or false negative values resulting from improperly collected, transported or handled specimens. 

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

Nucleic Acid Amplification