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U.S. Department of Health and Human Services

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Fact Sheet for Healthcare Providers: Interpretation of the DIATHERIX H1N1-09 Influenza Virus Test Results

The information previously contained on these webpages were authorized under the 2009 H1N1 Influenza Emergency Use Authorizations (EUAs). As of June 23, 2010, the EUAs have been terminated and this information is no longer current.

October 9, 2009

A public health emergency has been declared by the Secretary of Health and Human Services because of the outbreak of the 2009 H1N1 influenza virus which is also referred to as swine influenza (H1N1) virus. This Fact Sheet will refer to the virus as 2009 H1N1 influenza virus. The Food and Drug Administration (FDA) has authorized the emergency use of the DIATHERIX H1N1-09 Influenza Virus Test to test for the presence of the 2009 H1N1 influenza virus in clinical specimens collected via nasopharyngeal swabs, nasal swabs, throat swabs, nasal aspirates, and nasopharyngeal aspirates under an Emergency Use Authorization (EUA). This authorization will terminate on April 26, 2010, when the emergency has ceased to exist, or when the authorization has been revoked, whichever is earlier. The information in this Fact Sheet is the minimum necessary to inform you of the significant known and potential risks and benefits of the emergency use of the DIATHERIX H1N1-09 Influenza Virus Test.

 At this time, there are no FDA-approved/cleared tests that identify the existence of the 2009 H1N1 influenza virusin clinical specimens. Previously, the FDA has issued EUAs for the CDC Swine Influenza rRT-PCR Detection Panel to be used on the Applied Biosystems (ABI) 7500 Fast Dx instruments and for the Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR to be used on the ABI 7500 Real-Time PCR instrument. The current EUA authorizes use of the DIATHERIX Laboratories H1N1-09 Influenza Virus Test on the ABI 9700 thermocycler followed by detection on the Qiagen Luminex LiquiChip 100 platform to detect 2009 H1N1 influenza virus infections. Current information on 2009 H1N1 influenza virus, including case definitions and infection control guidelines, is available at http://www.cdc.gov/h1n1flu/. All information and guidelines, including those on testing for 2009 H1N1 influenza A virus, may change as we continue to learn more about this disease. Please check CDC’s 2009 H1N1 influenza virus Web site regularly for the most current information.

The DIATHERIX H1N1-09 Influenza Virus Test should be ordered only to diagnose 2009 H1N1 influenza virus infection. This test is not authorized for the detection of seasonal influenza A, B, or influenza C viruses or any other pathogens. The specimens should be collected using the DIATHERIX collection pack (available upon request) and sent by FedEx to DIATHERIX Laboratories, Inc. Specimen collection and transport should be conducted in accordance with the clinical protocol found in the DIATHERIX Laboratories Client Service Manual, which may be found online at www.diatherix.com/client_support.php, and in accordance with FedEx policies.

What does it mean if the specimen tests positive for the 2009 H1N1 influenza virus?

A positive test result for 2009 H1N1 influenza virus using the DIATHERIX H1N1-09 Influenza Virus Test indicates that the patient is infected with the 2009 H1N1 influenza virus. The test does not indicate the stage of the infection. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis. For guidelines on managing patients please refer to ”Interim Guidance for Infection Control for Care of Patients with Confirmed or Suspected Swine Influenza A (H1N1) Virus Infection in a Healthcare Setting” and ”Interim Guidance on Antiviral Recommendations for Patients with Confirmed or Suspected Swine Influenza A (H1N1) Virus Infection and Close Contacts” at http://www.cdc.gov/h1n1flu/guidance/.

The DIATHERIX H1N1-09 Influenza Test has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, the risk to patients could include any or all of the following: recommendations to limit contact with uninfected persons (including at home or at the workplace), a prescription for antiviral medication or other therapy, the impaired ability to detect and receive appropriate medical care for the true infection causing the flu-like symptoms, or other unintended adverse effects.

What does it mean if the specimen tests negative for the 2009 H1N1 influenza virus?

Negative results do not preclude an influenza virus infection and should not be used as the only basis for treatment or other patient management decisions. The clinical features of the illness and the type and risk of exposure are the keys to making patient management and isolation decisions. A negative test result from the DIATHERIX H1N1-09 Influenza Test should not be interpreted as a determination that the patient is not infected with the 2009 H1N1 influenza virus if other characteristics of the patient’s clinical presentation or recent epidemiologic exposures indicate that 2009 H1N1 influenza virus infection is likely, and diagnostic tests for other causes of acute respiratory illness are negative. This test is not authorized for the detection of seasonal influenza A, B, or influenza C viruses.

Contact Information for DIATHERIX Laboratories:

DIATHERIX Laboratories
601 Genome Way Suite 4208
Huntsville AL 35806
Contact Phone: 256-327-0699

Healthcare providers will be contacted by DIATHERIX Laboratories in the event of any significant new findings observed during the course of the emergency use of the DIATHERIX Laboratories H1N1-09 Influenza Virus Test.