H1N1 Influenza (Swine Flu) In-House Testing

CPL is now offering Influenza A H1N1 (2009) PCR (Swine Flu or Novel Influenza A) testing in-house.  This test aids in the detection and differentiation of seasonal Influenza A viral infection and infection by the 2009 H1N1 Influenza virus.  Both results will be on the report.  The Unit code is 4975 – Influenza A H1N1 (2009) PCR.  The preferred specimens are nasopharyngeal or nasal swabs in M4 transport media.  Swabs must be sterile Dacron, nylon or rayon with plastic shafts.  DO NOT USE calcium alginate swabs.  Specimen collection should be conducted according to the manufacturer’s instructions for the specimen collection device.  Acceptable specimens are throat swabs or nasal aspirates.  Transport temperature is critical refrigerated.  Maximum lab time is 1-3 days.  All positive results will be considered as alert values and will be called to the physician.

This test has not been FDA cleared or approved but is authorized by the FDA under an Emergency Use Authorization which will expire on April 26, 2010.  This test can only be run by CLIA High Complexity Laboratories such as CPL.  Each report must have a Healthcare Provider Fact Sheet and a Patient Fact Sheet.

This test is a limited coverage test for Medicare.  Advanced Beneficiary Notice is required if diagnosis is not covered.  

For further information of Influenza A H1N1 testing go to http://www.cdc.gov/h1n1flu/guidance/rapid_testing.htm