Limitations

This assay cannot differentiate between Rhinovirus/Enterovirus. If necessary for patient care, a positive result for Rhinovirus/Enterovirus may be followed-up using an alternate method. This assay should not be used if B. pertussis infection is specifically suspected as it is less sensitive than other alternatives. If suspected, ensure that B. pertussis specific testing is ordered. Recent administration of a nasal influenza vaccine may cause false positive results for Influenza A and/or Influenza B.
Viral and bacterial nucleic acids may persist even though no viable organism is present. Detection of nucleic acid does not imply that the corresponding organisms are infectious or are the causative agents of clinical symptoms. A negative result does not exclude the possibility of viral or bacterial infection and should not be used as the sole basis for patient management decisions. Assay performance characteristics may vary with circulating strains and this assay may not be able to distinguish between existing viral strains and new variants as they emerge. Invalid results may be due to inhibiting substances in the specimen and recollection should occur.