Cpt Code:

Clinical Utility

Influenza A viruses are medically important pathogens that cause significant mortality and morbidity throughout the world. Recently, the emergence of the 2009 H1N1 influenza A virus has led to increased vigilance in monitoring these infections. Utilizing molecular testing to diagnose 2009 H1N1 influenza A infections has been demonstrated to improve the outcomes of patients at highest risk for complications. Specifically, PCR-based assays have been proven to be the most sensitive tools for detection and identification of 2009 H1N1 influenza A.

Procedure

The assay consists of two portions; the first portion tests for all strains of influenza A utilizing the matrix gene and the second portion tests specifically for 2009 H1N1 influenza A utilizing the hemagglutinin gene.

Extraction of influenza A nucleic acid from respiratory specimen, followed by reverse transcription of viral RNA, then amplification and detection of cDNA using real-time PCR. An internal control is added to ensure the extraction was performed correctly and the PCR reaction was not inhibited. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

The primers and probes used in this assay are specific for influenza A and 2009 H1N1 influenza A, respectively, based on similarity search algorithms. For the influenza A portion of the assay, no cross reactivity was detected when tested against influenza B, RSV A, RSV B, parainfluenza 1, parainfluenza 2, parainfluenza 3, hMPV, rhinovirus, and adenovirus. Additionally, no cross reactivity was detected for the 2009 H1N1 influenza A portion of the assay when tested against influenza A subtypes, seasonal H1N1 and H3N2, influenza B, RSV A, RSV B, parainfluenza 1, parainfluenza 2, parainfluenza 3, hMPV, rhinovirus, and adenovirus.

Assay Range

Limit of Detection (LOD): 500 copies/mL. Detects available influenza A subtypes and reported strains of 2009 H1N1 influenza A. Differentially reports 2009 H1N1 influenza A, if present. Qualitative results (Detected/Not Detected).

Causes For Rejection

Wood shafted swab, calcium alginate swab, specimens received in trap containers, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

Turnaround Time

Same day (within 8 to 12 hours of receiving specimen), Monday through Saturday

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086

Specimen Information

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Type and Specimen Handling field above.

The CPT codes provided are based on Viracor-IBT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor-IBT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

PCR tests are performed pursuant to a license agreement with Roche Molecular Systems, Inc.