2009 H1N1 Influenza Virus Testing

As of May 24, 2010

FDA Clears Simplexa 2009 H1N1 Test

The Simplexa™ Influenza A H1N1 (2009) test on the 3M™ Integrated Cycler, developed and manufactured by Quest Diagnostics’ Focus Diagnostics business, is the first to be cleared by the FDA for use as an aid in the detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA. Read the press release.

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.

Quest Diagnostics Supports Pregnant Woman Needing H1N1 Testing

Quest Diagnostics offers free 2009 H1N1 influenza virus testing services to pregnant woman who are not insured. According to the CDC, infection with the H1N1 virus increases health risks for pregnant woman. For more information, physicians should consult the Quest Diagnostics in the region near them. Please refer to our list of regional laboratories and phone numbers. Interested patients should speak with their physicians about how to participate in the program.



	2009 H1N1 Influenza Virus Testing As of May 24, 2010 FDA Clears Simplexa 2009 H1N1 Test The Simplexa™ Influenza A H1N1 (2009) test on the 3M™ Integrated Cycler, developed and manufactured by Quest Diagnostics’ Focus Diagnostics business, is the first to be cleared by the FDA for use as an aid in the detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA. Read the press release. 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. Quest Diagnostics Supports Pregnant Woman Needing H1N1 Testing Quest Diagnostics offers free 2009 H1N1 influenza virus testing services to pregnant woman who are not insured. According to the CDC, infection with the H1N1 virus increases health risks for pregnant woman. For more information, physicians should consult the Quest Diagnostics in the region near them. Please refer to our list of regional laboratories and phone numbers. Interested patients should speak with their physicians about how to participate in the program.