This test provides simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections.
This panel does not detect the 2019 Novel Coronavirus (2019-nCoV). Any positive or negative coronavirus result should not be used to diagnose patients for the 2019-nCoV. Please refer to the CDC website for testing recommendations.
The performance of this test has not been established for patients without signs and symptoms of respiratory infection. 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.