2009 H1N1 Influenza Virus Testing
As of November 9, 2009
As the world's leading diagnostic testing company, Quest Diagnostics is committed to providing a range of quality influenza testing options to physicians and patients. These options include two commercial 2009 H1N1 influenza virus tests authorized by the U.S. Food and Drug Administration (FDA) for use during the pandemic emergency.*
In addition, we provide answers to Frequently Asked Questions about the 2009 H1N1 influenza virus, our influenza testing services, and public health guidelines for influenza testing.
2009 H1N1 Testing Options
Influenza A H1N1 (2009) Real Time RT-PCR*
- Test ordering information
- Patient fact sheet
- Health care provider fact sheet
- Product insert
- Press release announcing the emergency use authorization (July 2009)
- Press release announcing the availability of the test as a new commercial test kit (May 2009)
Simplexa™ Influenza A H1N1 (2009) Test on the 3M™ Integrated Cycler*†
- Patient fact sheet
- Health care provider fact sheet
- Product insert
- Press release announcing another emergency use authorization (Oct. 2009)
* This test was developed by Focus Diagnostics, a business of Quest Diagnostics. The test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization. This test is only authorized 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 or revoked sooner or renewed.
† Quest Diagnostics intends to employ this test in certain laboratories by the end of 2009. In the meantime, physicians should refer to Test Ordering Information for the Influenza A H1N1 (2009) Real Time RT-PCR.
Note to Lab Managers: For more information on purchasing the company's 2009 H1N1 flu tests, visit www.FocusDx.com.
Other Influenza Virus Testing Options
Quest Diagnostics' regional laboratories perform a broad range of testing services to detect influenza viruses. Depending on the laboratory, these services include polymerase chain reaction, rapid cell culture, direct immunofluorescence (DFA) and enzyme immunoassay (EIA) testing techniques. The company can perform influenza testing on different types of collected specimens, such as nasopharyngeal swabs, nasal secretions, nasal wash (lavage) and aspirations. Influenza testing options, availability and turnaround times vary by Quest Diagnostics laboratory.
Physicians should contact the nearest Quest Diagnostics' regional laboratory. Please visit our Facilities page and refer to the section titled "Quest Diagnostics Major Laboratory Facilities" to identify the location and phone number of a laboratory. When calling, please indicate that you wish to speak with a Medical Director about influenza testing.