Viral and bacterial nucleic acids may persist in vivo independent of organism viability.
A negative result does not exclude the possibility of viral or bacterial infection. Negative test results may occur from the presence of sequence variants in the region targeted by the assay, the presence of inhibitors, technical error, sample mix-up or and infection caused by and organism not detected by the panel. Test results may also be affected by concurrent antiviral/antibacterial therapy levels of organisms in the specimen that are below the limit of detection for the test. Negative results should not be used as the sole basis for diagnosis, treatment, or other management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen.
Positive and negative predictive values are highly dependent on prevalence. False negative test results are more likely during peak activity when prevalence of disease is high. False positive test results are more likely during periods when prevalence is moderate to low.
Due to the genetic similarity between Human Rhinovirus and Enterovirus, the Respiratory Pathogen Panel cannot reliably differentiate them.