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As of August 20, 2009
Specialty Laboratories is providing information to help physicians and patients understand their testing options for the 2009 H1N1 influenza virus and other influenza viruses.
FDA Authorizes the Influenza A H1N1 (2009) Real Time RT-PCR For Use in 2009 H1N1 Influenza Virus Pandemic Flu Emergency
First Commercial Test that Can Qualitatively Detect RNA of Pandemic Flu Virus
On July 24, 2009, the U.S. Food and Drug Administration (FDA) announced that it has granted emergency use authorization
(EUA) to Focus Diagnostics for its real-time polymerase chain reaction (PCR) test intended for the in vitro qualitative
detection of 2009 H1N1 influenza virus RNA (the "pandemic flu virus"). Specialty Laboratories is an affiliate of Focus
Diagnostics, the infectious disease business of Quest Diagnostics. The test is named the Influenza A H1N1 (2009) Real Time RT-PCR ("the test" or "our test").
Specialty Laboratories provides the test in alignment with requirements set forth by the FDA for emergency use authorization. The FDA has not cleared or approved this test. Under the EUA, the FDA has only authorized its use for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1). The declaration of emergency will expire on April 26, 2010, unless it is terminated, revoked sooner or renewed. The test is intended to be used on nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs (TS), and nasal aspirates (NA) from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors.
The Influenza A H1N1 (2009) Real Time RT-PCR is the first commercial test for detecting the 2009 H1N1 influenza virus to be granted emergency use authorization by the FDA during the pandemic flu emergency. It is also the first commercial laboratory test capable of qualitatively detecting the RNA of the 2009 H1N1 influenza virus. Specifically, it targets two separate regions of the hemagglutinin gene of the 2009 H1N1 influenza virus to differentiate the presence of seasonal human influenza A virus and the 2009 H1N1 influenza virus.
Public Health Guidelines
U.S. Federal, state and county public health authorities provide requirements for public health reporting and, in some cases, 2009 H1N1 influenza virus testing. The nature of these government guidelines varies by region and agency, and is subject to frequent change.
Specialty Laboratories adheres to applicable Federal, state and county public health guidelines. We report influenza findings and refer samples to the local public health authorities for confirmatory testing as required by these guidelines.
When the 2009 H1N1 influenza virus first began to spread, state and county public health guidelines generally required private clinical laboratories to provide specimens that tested positive for influenza virus type A to public health authorities for confirmatory testing and diagnosis of 2009 H1N1 influenza virus infection. Now, most state and county public health authorities continue to require results reporting of positive test results, but only require confirmatory testing for the 2009 H1N1 influenza virus on specimens from certain high risk patients or under certain circumstances.
It is important for physicians to understand applicable guidelines when treating a patient suspected of being infected
with the influenza type A virus, including the 2009 H1N1 influenza virus. Physicians may refer to a list of public health
authorities by U.S. state and county provided by Specialty Labs for more information. Clients who are unsure of the appropriate public health authority to contact, or who require clarification, should contact Specialty Laboratories client relations at 800.421.4449.
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