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Test Code HPFLU Influenza Virus Type A and Type B and Respiratory Syncytial Virus (RSV) RNA, Molecular Detection, PCR, Varies


Specimen Required


Preferred:

Specimen Type: Nasopharyngeal swab

Container/Tube: Sterile container with viral transport media

Specimen Volume: Entire specimen with a minimum of 1.5 mL (maximum 3 mL) of transport media.

Collection Instructions:

1. Collect specimen by swabbing back and forth over mucosa surface to maximize recovery of cells.

2. Swab must be placed into viral transport media (eg, M4-RT, M4 or M5), saline, or phosphate buffered saline (PBS). Media should not contain guanidine thiocyanate (GTC).

 

Specimen Type: Bronchoalveolar lavage fluid

Container/Tube: Sterile container

Specimen Volume: 0.6 mL

Additional Information: Do not aliquot into viral transport media.

 

Acceptable:

Specimen Type: Oropharyngeal (throat) swab, nasal mid-turbinate, or nares/nasal swab

Supplies:

-Culturette (BBL Culture Swab) (T092)

-Mid Turbinate (MT) Swab (FLOQSwab/COPAN) (T864)

-Swab, Sterile Polyester (T507)

Container/Tube: Sterile container with transport media

Specimen Volume: Entire specimen with a minimum of 1.5 mL (maximum 3 mL) of transport media.

Preferred: BBL Culture Swab, COPAN Mid-turbinate Swab

Acceptable: Dacron-tipped swab with plastic handle

Collection Instructions: Swab must be placed into viral transport media (eg, M4-RT, M4, or M5), saline, or PBS. Media should not contain guanidine thiocyanate (GTC).

 

Specimen Type: Bronchial washings, endotracheal aspirate, sputum

Container/Tube: Sterile container

Specimen Volume: 0.6 mL

Additional Information: Do not aliquot into viral transport media.


Secondary ID

610411

Useful For

Simultaneous detection of influenza A virus, influenza B virus, and respiratory syncytial virus in upper or lower respiratory tract specimens from individuals with flu-like illnesses

Method Name

Multiplex Reverse Transcriptase, Real-Time Polymerase Chain Reaction (RT-qPCR)

Specimen Type

Varies

Specimen Minimum Volume

Upper respiratory tract swab: See Specimen Required; Lower respiratory specimens: 0.3 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Frozen (preferred) 14 days
  Refrigerated  72 hours

Reject Due To

Bloody specimen Calcium alginate-tipped swab
Wooden shaft swab
Dry swab Glass transport media tubes
Transport swab containing gel or charcoal additive Sample tubes containing guanidine isothiocyanate, guanidine thiocyanate, or guanidine hydrochloride		 Reject

Reference Values

Undetected

Interpretation

A "Detected" (positive) test result indicates that the patient is presumptively infected with the indicated virus. The test does not indicate the stage of infection. Rarely, more than one virus may be detected from the same patient specimen. Laboratory test results should always be considered in the context of clinical observations and epidemiologic data in making a final diagnosis.

 

An “Undetected” (negative) test result suggests that the patient is not infected with influenza A virus, influenza B virus, or respiratory syncytial virus (RSV).

 

An "Inconclusive" result indicates that the presence or absence of influenza A virus, influenza B virus, and RSV in the specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to real-time, reverse transcription polymerase chain inhibition. Submission of a new specimen for testing is recommended.

Method Description

The SARS-CoV-2/Flu A/B/RSV assay (Panther Fusion System, Hologic, Inc) is a fully automated, multiplexed, real-time polymerase chain reaction (PCR) in vitro diagnostic assay cleared by the US Food and Drug Administration (FDA). for qualitative detection and differentiation of SARS-CoV-2, influenza A virus (Flu A), influenza B virus (Flu B), and respiratory syncytial virus (RSV) in nasopharyngeal (NP) specimens (ie, upper respiratory tract [URT] specimens) obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. In addition to testing URT specimens, this assay is being used to test lower respiratory tract (LRT) specimens, which are not cleared by FDA for testing with this assay. In the testing laboratory, 0.5 mL of the viral transport medium with URT swab is transferred to the Hologic Specimen Lysis Tube (SLT) to be loaded onto the Panther Fusion system. For LRT specimens, 0.25 mL of the specimen from the transport container and 0.25 mL of sterile Gibco 1x PBS, pH 7.4, are transferred into the SLT for loading onto the instrument system.

 

This assay involves the following steps: sample lysis, nucleic acid capture and elution transfer, and multiplex RT-PCR in which analytes are simultaneously amplified, detected, and differentiated.  Nucleic acid capture and elution takes place in a single tube on the Panther Fusion system. The Internal Control-S (IC-S) is added to each test specimen, positive and negative assay controls via the working Panther Fusion Capture Reagent-S. The IC-S reagent monitors specimen processing, amplification, and detection. The eluate is transferred to the Panther Fusion system reaction tube containing the assay reagents, and multiplex RT-PCR is then performed on the eluted nucleic acid.

 

Viral target-specific forward and reverse primers and probes simultaneously amplify, detect, and discriminate among the viral target sequences with various fluorescence channels. The assay software compares the fluorescence signals generate to predetermined cutoff values to produce a qualitative result for the presence or absence of each virus.(Instruction manual:SARS-CoV-2/ Flu A/B/RSV assay [Panther Fusion System],  AW-27555-001.Hologic, Inc; Rev. 001, 05/2023)

Day(s) Performed

Monday through Sunday

Report Available

Same day/1 to 2 days

Specimen Retention Time

4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87631

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HPFLU Influenza A/B and RSV, PCR, Varies 92143-7

 

Result ID Test Result Name Result LOINC Value
HPFLS Influenza A/B and RSV, Source 31208-2
610412 Influenza A virus PCR 92142-9
610413 Influenza B virus PCR 92141-1
610414 Respiratory Syncytial Virus, PCR 92131-2

Forms

If not ordering electronically, complete, print, and send an Microbiology Test Request (T244) with the specimen.