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Influenza A / Influenza B / RSV RT-PCR

Test Code: see Specimen Information section
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Clinical Utility

The Influenza A, Influenza B and RSV RT-PCR test is intended for the quantitative detection of Influenza A, Influenza B and Respiratory Syncytial Virus.

 

About Influenza A and B, and RSV

 

Human Influenza A viruses are medically important pathogens that cause significant morbidity and mortality throughout the world. The emergence of the 2009 H1N1 influenza A virus has led to increased vigilance in monitoring these infections. Unlike Influenza A viruses, Influenza B virus is found only in humans. Influenza B virus is a negative-sense, single-stranded RNA. Type B flu may cause a less severe reaction than type A flu virus, but type B can still be extremely harmful for the immunocompromised.

Human respiratory syncytial virus (RSV), a negative-sense, single-stranded RNA virus, causes a variety of respiratory illnesses. In at risk infants and children, it can cause bronchitis, croup, and lower respiratory infections like bronchiolitis and pneumonia. Premature infants, very young infants, and those with chronic (always present) lung or heart disease or with suppressed (weakened) immune systems have a greater chance of having a more severe infection such as a lower respiratory tract infection. Symptomatic RSV infections may occur in adults, particularly in healthcare workers or caretakers of small children. High-risk adults, such as those with certain chronic illnesses or immunosuppression, may have more severe symptoms consistent with a lower respiratory tract infection, such as pneumonia.

Procedure

Extraction of Influenza A, Influenza B, and RSV virus nucleic acid from specimen, followed by combined reverse transcription of viral RNA and PCR amplification using real-time reverse transcriptase PCR (RT-PCR) methods. An internal control is added to ensure that extraction was performed correctly and that the RT-PCR reaction was not inhibited.

This test was developed and its performance characteristics determined by Viracor Eurofins. It has not been cleared or approved by the U.S. Food and Drug Administration. Results should be used in conjunction with clinical findings, and should not form the sole basis for a diagnosis or treatment decision.

Specificity

 

Influenza A and B qRT-PCR

The primers and probes used in the INFA assay are specific for known H3N2, pandemic (2009) H1N1 and seasonal H1N1 and the primers and probes used in the INFB assay are specific for known INFB strains.  Additionally, no cross reactivity was detected when tested against ADV, CMV, EBV, HSV-1, HSV-2, Enterovirus, Parainfluenza virus, Coronavirus 229E, SARS CoV-2, Rhinovirus, RSVA, RSVB,  C. pneumoniae and Group A Strep.  In silico analysis has demonstrated that Viracor’s INFA or INFB assays are not expected to cross-react with other respiratory viruses, bacteria or fungal pathogens/commensals.

RSV qRT-PCR
The primers and probes used in the RSV assays are specific for known RSVA and RSVB strains.  Additionally, no cross reactivity was detected when tested against ADV, CMV, EBV, HSV-1, HSV-2, Enterovirus, Coronavirus 229E, SARS CoV-2, Rhinovirus, Influenza H1N1 2009 Pandemic, Influenza H1N1 Seasonal, Influenza H3N2, Influenza B, C. pneumoniae and Group A Strep.  In silico analysis has demonstrated that Viracor’s RSV assays are not expected to cross-react with other respiratory viruses, bacteria or fungal pathogens/commensals. This assay does not differentiate between RSVA or RSVB.

During this unprecedented time of high volume, the turnaround time for most samples is 24-48 hours from receipt of specimen in the lab.  As daily volume can have an impact on workflow, we are monitoring this closely and will provide updates as the situation changes.

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
BAL [Quant] PFL8019 87631 No

2 mL

Flu A: 361 - 1.00E+09 copies/mL
Flu B: 91 - 1.00E+09 copies/mL
RSV: 579 - 1.00E+09 copies/mL

  • Volume requirements: 2 mL
  • Collect in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient or refrigerated temperature must be received within 7 days of collection, or 28 days when frozen.
bronch wash [Quant] PFL8019 87631 No

2 mL

Flu A: 361 - 1.00E+09 copies/mL
Flu B: 91 - 1.00E+09 copies/mL
RSV: 579 - 1.00E+09 copies/mL

  • Volume requirements: 2 mL
  • Collect in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient or refrigerated temperature must be received within 7 days of collection, or 28 days when frozen.
nasal swab [Quant] PFL8018 87631 No

3 mL

Flu A: 559 - 1.00E+09 copies/mL
Flu B: 327 - 1.00E+09 copies/mL
RSV: 459 - 1.00E+09 copies/mL

  • Place sterile swab in 2-3 mL sterile buffered saline or transport media in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient or refrigerated temperature must be received within 7 days of collection, or 28 days when frozen.
NP swab [Quant] PFL8018 87631 No

3 mL

Flu A: 559 - 1.00E+09 copies/mL
Flu B: 327 - 1.00E+09 copies/mL
RSV: 459 - 1.00E+09 copies/mL

  • Place sterile swab in 2-3 mL sterile buffered saline or transport media in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient or refrigerated temperature must be received within 7 days of collection, or 28 days when frozen.
BAL [Qual] PFL8021 87631 No

2 mL

Detected / Not Detected

  • Collect in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient or refrigerated temperature must be received within 7 days of collection, or 28 days when frozen.
bronch wash [Qual] PFL8021 87631 No

2 mL

Detected / Not Detected

  • Collect in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient or refrigerated temperature must be received within 7 days of collection, or 28 days when frozen.
bronch wash [Qual] PFL8020 87631 No

3 mL

Detected / Not Detected

  • Place sterile swab in 2-3 mL sterile buffered saline or transport media in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient or refrigerated temperature must be received within 7 days of collection, or 28 days when frozen.
NP swab [Qual] PFL8020 87631 No

3 mL

Detected / Not Detected

  • Place sterile swab in 2-3 mL sterile buffered saline or transport media in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient or refrigerated temperature must be received within 7 days of collection, or 28 days when frozen.
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 Eurofins test requisition form must accompany each specimen. For additional testing, please send a separate specimen. Refer to our website for accepted specimen types. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 1001 NW Technology Dr, Lee's Summit, MO 64086.

Causes for Rejection

Dry swab, 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.

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

The CPT codes provided are based on Viracor Eurofins' 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 Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

We will continue to follow federal and state requirements for both notification of results and any confirmatory testing that is required by another agency.

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