Influenza A H1N1 (2009) Real-Time RT-PCR



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Test Summary

Clinical Use

Aid in the detection and differentiation of seasonal influenza A virus infection and 2009 H1N1 influenza virus infection

This 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.

For more information, refer to the healthcare provider and patient fact sheets found at http:

//www.QuestDiagnostics.com/2009H1N1Physician/fact_sheet.pdf and http://www.Quest

Diagnostics.com/2009H1N1Patient/fact_sheet.pdf.

Clinical Background

The 2009 H1N1 influenza virus is a novel virus containing genes from swine, avian, and human influenza viruses. Like seasonal flu, it is spread from person-to-person via respiratory droplets, contaminated surfaces, and airborne droplet nuclei. Symptoms associated with uncomplicated disease include fever, chills, headache, body aches, fatigue, cough, sore throat, runny nose, shortness of breath, vomiting, and diarrhea. Severity of disease ranges from mild to life-threatening.

In June 2009, the World Health Organization (WHO) reported spread of the 2009 H1N1 influenza virus to >70 countries and declared a phase 6 global H1N1 pandemic. Unlike seasonal flu viruses, the H1N1 has continued to infect people in the U.S. during the summer months, and the pandemic is expected to continue into the normal flu season.

Individuals Suitable for Testing

Clinicians should follow testing guidelines provided by the Centers for Disease Control and Prevention (CDC) and their local public health agency. Links to the CDC and local public health organization Web sites can be found at http://www.QuestDiagnostics.com/2009H1N1/.

Specimen Requirements

Refrigerated nasal swab, nasopharyngeal swab, throat swab, or nasal aspirate in 3 mL viral transport medium, multi-microbe media (M4), V-C-M medium (green-cap tube), or equivalent universal transport medium (UTM); 0.35 mL minimum

Swabs: use only sterile Dacron, nylon, or rayon swabs with plastic shafts; do not use calcium alginate swabs; break applicator sticks off near tip to permit tightening of the cap

Method

The Influenza A H1N1 (2009) Real-Time RT-PCR uses PCR technology to target 2 separate regions of the hemagglutinin gene of the 2009 H1N1 influenza virus and 1 region of the matrix gene common to all influenza A viruses to differentiate the presence of the pandemic virus from seasonal human influenza A virus. Test results are reported as either “not detected” or “detected” for influenza A RNA and for 2009 influenza H1 gene.

CPT code*: 87798 x2

Reference Range

Not detected

Interpretive Information

A “not detected” influenza A RNA result is consistent with the absence of an influenza A viral infection, whereas a “detected” result is consistent with presence of an influenza A infection.

Detection of the 2009 influenza H1 gene is consistent with the presence of a 2009 H1N1 influenza virus infection. Not detected (negative) results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Test results should be interpreted in light of the patient’s symptoms, medical background, and other factors.

References

Novel H1N1 Flu (Swine Flu). Centers for Disease Control and Prevention Web site. http://www.cdc.gov/H1N1FLU. Accessed July 30, 2009.

*The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.

Polymerase chain reaction (PCR) is performed pursuant to a license agreement with Roche Molecular Systems, Inc.

Content reviewed 08/2009

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