Testing resources for H5N1 Bird Flu

As a reminder for AMP members, feel free to use the CHAMP community when you have questions for your AMP colleagues regarding bird flu.

GENERAL INFORMATION

Information on Bird Flu (CDC)

CDC Bird Flu Update Feb 2025 (AMA) Additional Videos

What to Know About Bird Flu Handout (CDC)

Influenza (Avian and other zoonotic) Fact Sheet (WHO)

H5N1 Technical Report (CDC)

2020-2024 Highlights and History of Avian Influenza (CDC)

LATEST UPDATES

Current Situation Summary (CDC)

Current U.S. Bird Flu Situation in Humans (CDC)

How CDC is Monitoring Influenza Data (CDC)

Updates on Highly Pathogenic Avian Influenza (HPAI) (FDA)

Investigation of Avian Influenza A (H5N1) Virus in Dairy Cattle (FDA)

Infections in Livestock (USDA)

Genomic Tracking (Nextstrain)

United States HPAI Outbreak Tracking (GISAID)

Recent CLIAC Meeting (November 6-7, 2024)

DASHBOARDS

Human

• CDC Respiratory Virus Hospitalization Surveillance Network (RESP-NET)
• CDC National Wastewater Surveillance System (NWSS)
• CDC Influenza Hospitalization Surveillance Network (FluSurv-NET)
• CDC FluView Interactive 
• WHO FluNet
• WHO FluID
• WHO Global Influenza Surveillance and Response System (GISRS)

Non-Human

• USDA Animal and Plant Health Inspection Service (APHIS)
• DashFLUBoard (Avian)

CLINICIAN RESOURCES

Case Definitions (CDC)

General FAQ for Clinical Laboratories on Testing of HPAI H5N1 (ASM and APHL)

Interim Recommendations for Prevention and Monitoring (CDC)

Recommendations for Investigations and Response (CDC)

Evaluating and Managing Patients (CDC)

HAN: Accelerated Subtyping of Influenza A in Hospitalized Patients (CDC)

Use of Antivirals for Treatment (CDC)

Use of Antivirals Chemoprophylaxis (CDC)

What should Local Health Departments Know About Avian Influenza: A Q&A with CDC (National Association of County and City Health Officials (NACCHO))

Follow-up of Close Contacts of Persons Infected with HPAI (CDC)

LABORATORY RESOURCES

Laboratory Biosafety:

• Biosafety in Microbiological and Biomedical Laboratories—6th Edition (CDC)

  • See Pages 262, Highly Pathogenic Avian Influenza (HPAI) A Viruses 

  • Note that HPAI A viruses are CDC/USDA select agents! 

    • See BMBL 6 Appendix F for more information: Biosafety in Microbiological and Biomedical Laboratories—6th Edition (CDC)

Community Health Biosafety:

• Extension for Community Healthcare Outcomes Biosafety Program 

Infection Control and Safety When Collecting Specimens and Caring for Patients:  

• Interim Guidance for Infection Control Within Healthcare Settings When Caring for Confirmed Cases, Probable Cases, and Cases Under Investigation for Infection with Novel Influenza A Viruses Associated with Severe Disease (CDC)

CDC Laboratorian Guidance for Specimen Collection and Testing: 

• Interim Guidance on Specimen Collection and Testing for Patients with Suspected Infection with Novel Influenza A Viruses Associated with Severe Disease or with the Potential to Cause Severe Disease in Humans (CDC)

• Specimen Submission Form (CDC)

  • Before sending specimens, state and local health departments should contact the CDC Influenza Division Epidemiology and Prevention Branch at (404) 639-3747 Monday – Friday, 8:30 AM – 5:00 PM (or the on-call epidemiologist at (770) 488-7100 at all other times) or flusupport@cdc.gov.

• Influenza Specimen Collection (CDC)

  • Note that CDC recommends collecting a conjunctival swab from patients with conjunctivitis (see here). 

  • Collect both a conjunctival swab and a respiratory specimen (e.g., nasopharyngeal swab) even if the patient doesn’t have respiratory symptoms.   

FDA Influenza IVD Tests with FDA 510(K) Clearance, EUA, or de nova request for Humans:

• List of Influenza Diagnostic Tests

  • Influenza A/H5N1 Specific Detection Test 

  • Influenza A/H7N9 Specific Detection Test 

  • Influenza A/H1/H1pdm09/H3 Seasonal Subtyping Tests 

  • Influenza A Tests (no subtyping) 

Farm worker safety:

• Recommendations for Workers (USDA)

American Society for Microbiology Sentinel Level Clinical Laboratory Guidelines 

• Novel Influenza Viruses (ASM)

Information relevant to incidental detection of HPAI on routine influenza IVDs and LDTs 

• Labs are not encouraged to develop or validate specific LDTs for HPAIs at this time. 

• Labs can contact relevant IVD manufacturers for pan-Influenza A primer/probe coverage information on FDA cleared assays.  

• Labs that run LDPs for pan-Influenza A detection can refer to published sequences from recent human and bovine cases for primer/probe coverage: 

  • Technical Update: Summary Analysis of Genetic Sequences of Highly Pathogenic Avian Influenza A(H5N1) Viruses in Texas (CDC)

Avian Influenza A (H7N9) Virus

On April 22, 2013, the FDA issued an Emergency Use Authorization (EUA) for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay. More information is available from the FDA website. Note that issuance of this EUA does NOT indicate that an actual public health emergency exists in the United States. Distribution of diagnostic test kits domestically is a preparedness measure. For information on the latest available FDA H7 molecular assays via EUA, see the FDA website. These EUAs will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act. (CDC website)

CDC has developed diagnostic test materials to specifically detect the avian influenza A(H7N9) virus that was first identified in China in 2013. Testing with the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay should not be performed unless the patient meets clinical and epidemiologic criteria for testing suspect specimens.

• H7N9 Virus Testing for Laboratories Website contains information on U.S. Domestic and International kit ordering for PHLs, 
• Public health labs - order test kits from International Reagent Resource (IRR)
  • US domestic - CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/H7 (Eurasian Lineage) Assay (EUA) (Catalog No. FluEUA-01)
  • International - CDC Real-Time RT-PCR Influenza Virus A/H7 (Eurasian Lineage) Assay (RUO) (Catalog No. FluRUO-07) and the CDC Influenza A/H7 (Eurasian Lineage) Positive Control (EuH7PC) (RUO) (Catalog No. KK0818)
• Clinical, reference, and referral labs - CDC's A(H7N9) rRT-PCR primer sequences or testing protocols are available from CDC's Laboratory Support of Influenza Surveillance (CLSIS) Sharepoint website.