Respiratory Pathogen Panel

The performance of this test has not been established for patients without signs and symptoms of respiratory infection. Results must be interpreted in the context of the patient’s clinical history, epidemiological data, and other available diagnostic information. Viral and bacterial nucleic acids may persist in vivo regardless of organism viability; thus, detection does not necessarily indicate active infection or causative relevance to clinical symptoms. Accurate detection depends on proper specimen collection, handling, transport, storage, and processing—any deviation can result in incorrect results. There is a risk of false positives due to non-specific amplification or cross-reactivity, including with organisms not evaluated or emerging variants. Likewise, false negatives may occur due to sequence variation, inhibitors, technical error, sample mix-up, antimicrobial therapy, or pathogen levels below the test’s limit of detection. Negative results do not rule out infection and should not be the sole basis for diagnosis or treatment decisions. In the setting of respiratory illness, a negative result may reflect infection by pathogens not included in the panel or lower respiratory tract infections not detected by nasopharyngeal swab.