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Diagnostics for Detecting H7N9 Using rRT-PCR

A packaged CDC reagent kit for detecting H7N9 virus CDC has developed diagnostic test materials to specifically detect the new avian influenza A (H7N9) virus found in China. These test materials include rRT-PCR reagents (primers and probes), controls and an rRT-PCR test protocol.

Reagents and Controls for H7N9

These materials are available for ordering from the Influenza Reagent Repository (IRR) website.

Note: 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.

U.S. Domestic Ordering

U.S. qualified public health laboratories only can order the CDC H7N9 reagents and the positive control. The CDC H7N9 RT-PCR reagents and controls are intended for use in conjunction with CDC’s existing test kit (the Flu rRT-PCR Dx Panel) that is currently used by U.S. public health laboratories. Non public health entities can obtain primer sequences or testing protocols from the CLSIS website below.

International Ordering

International public health laboratories can order the CDC H7N9 reagents and the positive control. Requests from WPRO and SEARO countries will be prioritized, although all requests from National Influenza Centers (NICs) and national public health laboratories will be processed as soon as possible. To order the A(H7N9) reagents, NICs and national public health laboratories are encouraged to register with the IRR if they have not done so already, as web ordering will expedite the distribution process.

CDCFluorder@cdc.gov will remain open to assist those labs with extenuating circumstances; however, the IRR web page is the preferred method for ordering.

Emergency Use Authorization (EUA)

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.

H7N9 Test Protocols

CDC’s H7N9 rRT-PCR test protocol is available via CDC’s Laboratory Support of Influenza Surveillance (CLSIS) Sharepoint website. The CLSIS Sharepoint site provides technical support and guidance for influenza surveillance testing. As a registered user, laboratories will have access to influenza testing protocols as well as other technical support resources. All future updates and communications will be provided via this SharePoint site.

For further information or assistance, an email can be sent to clsis@cdc.gov.

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