At this time, no FDA-approved/cleared tests that identify existence of swine influenza virus in clinical specimens are available in the United States. Therefore, the Centers for Disease Control and Prevention (CDC) has developed this test to detect swine influenza virus infections. Current information on swine influenza, including case definitions and infection control guidelines, is available at http://www.cdc.gov/swineflu/. All information and guidelines, including those on swine influenza virus laboratory testing, may change as we continue to learn more about this disease. Please check CDC’s swine influenza virus website regularly for the most current information.

The rRT-PCR Swine Flu Panel test should be ordered to presumptively diagnose swine influenza A (H1N1) virus infection only. Nasopharyngeal or nasal swabs may be collected in the usual fashion and sent to a qualified laboratory for analysis. Specimen collection should be conducted per the clinical protocol and according to the manufacturer’s instructions for the specimen collection device.

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

A positive test result from the rRT-PCR Swine Flu Panel indicates that the patient is presumptively infected with swine influenza virus. The test does not indicate the stage of infection. Laboratory test results should always be considered in the context of clinical observations and epidemiologic 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/swineflu/investigation.htm.

The test has been designed to minimize the likelihood of false positive test results. However, should false positive results occur, risks to patients could include a recommendation for quarantine of household or other close contacts, a recommendation for patient isolation that might limit contact with family or friends, the ability to work, or the ability to receive certain medical care, prescription of an antiviral drug or other therapy, or other unintended adverse effects.

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

Negative results do not preclude influenza virus infection and should not be used as the sole 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 RT-PCR test should not be interpreted as demonstrating that the patient does not have swine influenza virus infection, if other aspects of the patient’s clinical presentation or recent epidemiologic exposures indicate swine influenza virus infection is likely, and diagnostic tests for other causes of acute respiratory illness are negative.

Contact Information for the Manufacturer:

CDC Influenza Division
1600 Clifton Road, MS-G03
Atlanta GA 30333
Contact phone 404-6390954

* Any significant new findings observed during the course of the emergency use of Swine Influenza RT-PCR assay will be made available at http://www.cdc.gov/swineflu/.

Why was my sample tested using the Swine Influenza Test Kit?

There are no FDA cleared or approved tests that can identify swine flu virus. Therefore, y our sample was tested using the Swine Influenza Test Kit because you may have been exposed to the swine flu virus. This test could help to determine whether you are infected with the swine flu virus, so that public health officials could quickly identify a case and limit its spread. The results of this test, along with other information, may also help your doctor take better care of you.

What is swine flu?

Swine flu is a respiratory disease of pigs caused by type A influenza virus that regularly causes outbreaks of influenza in pigs . Human cases of swine flu virus infection have been identified in the United States and internationally. CDC has determined that this virus is contagious and is spreading from human to human. Like seasonal flu, swine flu in humans can vary in severity from mild to severe.

What is the Swine Influenza Test Kit?

The Swine Influenza Test Kit is a sensitive test to detect the swine flu virus. The FDA has not cleared or approved this test. The FDA has agreed that we can use this test under an Emergency Use Authorization. We don’t know for sure if this test can identify all people who may get sick with swine flu.

What are the known risks and benefits of Swine Influenza Test Kit?

The results of this test from nasopharyngeal or nasal swab, along with other information, can help your doctor take better care of you. Knowing your test results may help you to prevent the spread of the virus to your family or others. There may be no other benefits to you from this test.

If this test is positive, does that mean that I have swine flu?

Yes, though there is a very small chance that this test can give a result that is wrong (false positive), it is not likely. If your result from this test is positive, your doctor may decide how to care for you based on the test results along with other factors.

If this test is negative, does that mean that I do not have swine flu?

If this test is negative, you may not be sick, or you may be sick with something that is not swine flu. There is a small chance that this can give a result that is wrong (false negative). A false negative result should not affect your care. No changes in your medical care or how you interact with other people should be solely based on a negative result.

* Any significant new findings observed during the course of the emergency use of Swine Influenza Test Kit will be made available at http://www.cdc.gov/swineflu/.

• to identify patients who may be infected with swine influenza virus (AIHlNl) to allow
  public health authorities to respond to and limit transmission the virus during this public
  health emergency,
• for qualitative detection of influenza virus type A in symptomatic patients from viral RNA
  in human nasopharyngeal and/or nasal swab specimens,
• for presumptive identification of virus in patients who may be infected with swine influenza
  A subtype AIHlN1 from viral RNA in human nasopharyngeal and/or nasal swabs specimens
  and viral culture in conjunction with clinical and epidemiological risk factors, and
• to provide epidemiologic information for surveillance for influenza viruses.

Testing with the swine influenza swInfA and swHl primer and probe sets should not be performed
unless the patient meets clinical and epidemiologic criteria for testing suspect specimens. The
definitive identification of swine influenza AIHlN1 either directly from patient specimens or from
virus cultures requires additional laboratory testing, along with clinical and epidemiological
assessment in consultation with national influenza surveillance experts.

Negative results do not preclude influenza virus infection and should not be used as the sole basis
for treatment or other patient management decisions.

The definitive identification of swine Influenza A (HlNl) virus from patient specimens requires
additional laboratory testing, along with clinical and epidemiological assessment in consultation
with national influenza surveillance experts.

All users, analysts, and any person reporting diagnostic results from use of this device
should be trained to perform and interpret the results from this procedure by a CDC
instructor or designee prior to use. CDC Influenza Divisioil will limit the distribution of
this device to only those users who have successfully completed training provided by CDC
instructors or designees.

Use Is limited to designated public health laboratories and other laboratories qualified to
receive and use the CDC rRT-PCR Flu Panel (IVD) KO80570