Influenza A (H5) Virus RNA, Qualitative Real-Time PCR, Respiratory and Conjunctiva

Quest offers 2 tests that can be used when an individual has tested positive for influenza A and H5 is suspected because signs and symptoms are consistent with avian influenza. They differ based on the specimen type: respiratory vs conjunctiva.

• Influenza A (H5) Virus RNA, Qualitative Real-Time PCR, Respiratory (test code 13998)
• Influenza A (H5) Virus RNA, Qualitative Real-Time PCR, Conjunctiva (test code 13997)

These tests are qualitative multitarget molecular diagnostic tests that help detect the influenza A H5 virus, including H5N1, commonly known as avian influenza. These tests do not detect influenza B or other respiratory viruses.

The tests are intended to be performed on their indicated specimen type (respiratory vs conjunctiva) collected from individuals suspected of infection with influenza A H5, or who meet the Centers for Disease Control and Prevention (CDC) clinical and/or epidemiological criteria for influenza A H5 testing.

For details, visit the following CDC website: Case Definitions for Investigations of Human Infection with Avian Influenza A Viruses in the United States | Bird Flu | CDC.¹

Influenza A (H5) Virus RNA, Qualitative Real-Time PCR, Respiratory (test code 13998)

• Preferred:

o    Nasopharyngeal, anterior nares, or oropharyngeal swab submitted in 1 mL VCM (green-cap) or equivalent (UTM) tube

OR

o    1 mL bronchial alveolar lavage (BAL)/wash collected in a sterile, leak-proof container

• Container: VCM, UTM equivalent or plastic leak-proof container

• Instructions: Each influenza A H5 specimen should be accompanied by its own separate requisition and transport container in its own sealed bag, which may differ from specimen collection instructions for testing performed at other laboratories

Influenza A (H5) Virus RNA, Qualitative Real-Time PCR, Conjunctiva (test code 13997)

• Preferred:

o    Conjunctiva swab submitted in 1 mL VCM (green-cap) or equivalent (UTM) tube

• Container: VCM, UTM equivalent or plastic leak-proof container
• Instructions: Each influenza A H5 specimen should be accompanied by its own separate requisition and transport container in its own sealed bag, which may differ from specimen collection instructions for testing performed at other laboratories

Specimens should be transported refrigerated (cold packs). Frozen specimens are also acceptable. 

These tests are Immediate Response tests and can only be ordered by a licensed healthcare professional (for prescription use only). These tests have not been reviewed or authorized by the FDA. They were developed and their analytical performance characteristics were determined by Quest Diagnostics pursuant to CLIA regulations for clinical purposes.

Performance characteristics are listed in Table 1. Studies were conducted in the R&D Infectious Disease and Molecular Infectious Disease Department at Quest Diagnostics Nichols Institute, 33608 Ortega Highway, San Juan Capistrano, California 92675.

Additional information is available upon request. 

Influenza antivirals are available. There is no reported resistance to the antiviral drugs approved by the Food and Drug Administration.

Candidate vaccines to prevent H5 infection have been developed, but they are not available for widespread use.

Seasonal influenza vaccine does not protect against H5.

Quest has several testing options available for influenza A and other respiratory viruses (Table 2).  Quest offers assays that will also type for the seasonal human influenza strains (ie, H1 and H3).

The influenza A subtyping tests (95512 and 37444) will not specifically identify an influenza A strain as H5 but would identify such a strain as a nontypable influenza A strain.