Download PDF

Assay Sheet

Test ID

7700 ViraCor 2009 H1N1 Influenza A Real-Time RT-PCR*

*FDA Emergency Use Authorization has been authorized for the 2009 H1N1 Influenza A result of the ViraCor 2009 H1N1 Influenza A Real-Time RT-PCR test (test code 7700):

• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an Emergency Use Authorization;
• This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or pathogens;
• 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); and
• The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.

CPT CODE 

87798 (x2)

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 lead 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.

Specimens

Bronchial Lavage/Bronchial Wash: 1 to 3 ml, collected in sterile, screw-cap tube; ship ambient.

Nasal aspirate (NA), Nasal wash (NW), Tracheal aspirate (TA), Endotracheal wash (EW), Endotracheal aspirate (EA), Broncial aspirate (BA), Bronchial wash (BW): Instill 1 to 2 ml sterile saline into desired location and gently aspirate contents. Place collected fluid into sterile, screw-cap tube; ship ambient. 

Nasal swab (NS), Nasopharyngeal swab (NPS), Throat swab (TS), Dual nasopharyngeal swab/throat swab (NPS/TS): Swab desired location with sterile, flexible shaft swab, preferably a flocked swab. Place swab into 1 to 2 ml sterile saline, M4, or viral transport media in sterile, screw-cap tube. Do not use calcium alginate swab or wood shafted swab; ship ambient.

All suction-type collection devices are inappropriate for specimen transport. Transfer specimen into sterile, leakproof tube for transport.

Causes for Rejection

Wood shafted swab, calcium alginate swab. Specimen types other than those listed above. Call ViraCor at 800-305-5198 if specimen is greater than 96 hrs old.

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.

Viracor 2009 H1N1 Influenza A Real-Time RT-PCR Assay Range

Limit of Detection (LOD): 500 copies/ml.

Detects available influenza A subtypes and reported strains of 2009 H1N1influenza A. Differentially reports 2009 H1N1 influenza A, if present. Qualitative results (Detected/Not Detected/Indeterminate).

Turnaround Time

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

Reflex Testing Options Available

Respiratory Viral Panel (RV00) Reflex to ViraCor 2009 H1N1 Influenza A Real-Time RT-PCR (7700)

ViraCor 2009 H1N1 Influenza A Real-Time RT-PCR (7700) Reflex to Respiratory Viral Panel (RV00)

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. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to:

ViraCor Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086

The CPT codes provided are based on ViraCor’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 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. This assay was developed and the performance characteristics were determined at ViraCor Laboratories. This test is performed in a CLIA certified laboratory. FDA approval is not required for the performance of this test.

0809 V1