Influenza Virus Testing Methods
- Serologic (antibody detection) testing is not recommended for routine patient diagnosis and cannot inform clinical management. A single acute serum specimen for seasonal influenza serology is uninterpretable and should not be collected. Serological testing for detection of antibodies to seasonal influenza viruses is useful for research studies and requires collection of appropriately timed acute and convalescent serum specimens and testing of paired sera at specialized research or public health laboratories.
- Approved clinical specimens vary by influenza test. Consult the manufacturer’s package insert for the approved clinical specimens for each test. Ref: Leland, et al. 2007, Clin Micro Rev 20: 49-78. Approved respiratory specimens vary among FDA cleared influenza assays.
- Clinical Laboratory Improvement Amendments (CLIA) of 1988. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html
- Chromatographic- and/or fluorescence-based lateral flow and membrane-based immunoassays. Some approved rapid influenza diagnostic assays utilize an analyzer reader device.
- NP = nasopharyngeal
- Rapid molecular assays can provide results in approximately 15-30 minutes. Alere i Influenza A&B is FDA-cleared for use with both nasal swabs (direct) and NP or nasal swabs in VTM, and CLIA-waived for use with nasal swabs (direct) only. Roche Cobas Influenza A/B is cleared and CLIA-waived by FDA for use with nasopharyngeal swabs only. Xpert Xpress Flu is cleared and CLIA-waived by FDA for use with nasopharyngeal swabs and nasal swabs. Xpert Xpress Flu/RSV is cleared for use with nasopharyngeal swabs, but is not CLIA-waived.
- Reverse transcription polymerase chain reaction, including FDA-approved test systems, reference laboratory testing using ASR or lab-developed reagents. Some approved molecular assays can produce results in approximately 60-80 minutes.
- VTM = Viral transport media
- Page last reviewed: March 26, 2018
- Page last updated: March 26, 2018
- Content source:
- Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases (NCIRD)
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