Test Id : HPFLU
Influenza Virus Type A and Type B and Respiratory Syncytial Virus (RSV) RNA, Molecular Detection, PCR, Varies
Useful For
Suggests clinical disorders or settings where the test may be helpful
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
Highlights
This assay simultaneously detects influenza viruses type A and type B and respiratory syncytial virus (RSV) in upper and lower human respiratory tract specimens in individual with signs and/or symptoms of upper or lower respiratory tract infection.
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For information see Coronavirus Disease 2019 (COVID-19), Influenza, and Respiratory Syncytial Virus Testing Algorithm.
Method Name
A short description of the method used to perform the test
Multiplex Reverse Transcriptase, Real-Time Polymerase Chain Reaction (RT-qPCR)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Flu
Influenza
Respiratory Syncytial Virus (RSV)
RSV
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For information see Coronavirus Disease 2019 (COVID-19), Influenza, and Respiratory Syncytial Virus Testing Algorithm.
Specimen Type
Describes the specimen type validated for testing
Varies
ORDER QUESTIONS AND ANSWERS
Question ID | Description | Answers |
---|---|---|
HPFLS | Influenza A/B and RSV, Source |
Oropharynx Nasopharynx Nares Nasal Nasal mid-turbinate Bronchoalveolar lavage (BAL) Bronchial washings Tracheal aspirate Sputum |
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
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.
Forms
If not ordering electronically, complete, print, and send an Microbiology Test Request (T244) with the specimen.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
Upper respiratory tract swab: See Specimen Required; Lower respiratory specimens: 0.3 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
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 |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Varies | Frozen (preferred) | 14 days | |
Refrigerated | 72 hours |
Useful For
Suggests clinical disorders or settings where the test may be helpful
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
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For information see Coronavirus Disease 2019 (COVID-19), Influenza, and Respiratory Syncytial Virus Testing Algorithm.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Influenza, otherwise known as the "flu," is an acute, contagious respiratory illness caused by influenza A, B, and C viruses. Of these, only influenza A and B are thought to cause significant disease, with infections due to influenza B usually being milder than infections with influenza A. Influenza A viruses are further categorized into subtypes based on the 2 major surface protein antigens: hemagglutinin (H) and neuraminidase (N).
Common symptoms of influenza infection include fever, chills, sore throat, muscle pains, severe headache, weakness, fatigue, and a nonproductive cough. Certain patients, including infants, older individuals, patients who are immunocompromised, and those with impaired lung function, are at risk for serious complications. In the United States, influenza results in 10,000 to 30,000 deaths and more than 200,000 hospitalizations each year.(1)
In the northern hemisphere, annual epidemics of influenza typically occur during the fall or winter months. However, the peak of influenza activity can occur as late as April or May, and the timing and duration of flu seasons vary.
Influenza infection may be treated with supportive therapy as well as antiviral drugs, such as the neuraminidase inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). These drugs are most effective when given within the first 48 hours of infection, so prompt diagnosis and treatment are essential for proper management.
Respiratory syncytial virus (RSV) is a respiratory virus that also infects the human respiratory tract, causing an influenza-like illness. Most otherwise healthy people recover from RSV infection in 1 to 2 weeks, but infection can be severe in infants, young children, and older adults. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children younger than 1 year in the United States. It is increasingly recognized as a frequent cause of respiratory illness in older adults.(2)
RSV and influenza viruses can be detected in respiratory secretions, including upper and lower respiratory tract specimens, by molecular test methods. Nasopharyngeal swabs or aspirates are the preferred specimen types for detection of influenza A virus, influenza B virus, and RSV. Nasal swabs have been shown to provide comparable yield to nasopharyngeal specimens for molecular detection of influenza A and B viral RNA but not RSV RNA.(3-4)
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Undetected
Interpretation
Provides information to assist in interpretation of the test results
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.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test has been designed to minimize the likelihood of false-positive test results. However, should false-positive results occur, risks to patients could include a recommendation for quarantine of household or other close contacts, a recommendation for patient isolation that might limit contact with family or friends, the ability to work, or the ability to receive certain medical care, prescription of an antiviral drug or other therapy, or other unintended adverse effects.
The sensitivity of the assay is very dependent upon the quality of the specimen submitted. A nasopharyngeal swab and bronchoalveolar lavage fluid are the preferred specimen types for optimal detection of respiratory syncytial virus (RSV) RNA in the upper and lower respiratory tracts, respectively.
The test is specific for influenza A virus, influenza B virus, and RSV; therefore, the results do not exclude the possibility of infection with other respiratory viruses. Influenza C virus is not detected by this assay.
This assay detects influenza A viral RNA but does not distinguish among the different viral subtypes.
"Undetected' (negative) results do not preclude infection with influenza A virus, influenza B virus, or RSV and should not be used as the sole basis for treatment or other patient management decisions.
This assay detects both replicating and nonreplicating virus (ie, remnant viral nucleic acid). Test performance depends on viral load in the specimen and may not correlate with cell culture performed on the same specimen.
The assay has not been US Food and Drug Administration approved for detection of influenza A H7N9, though comparison of primer and probe sequences indicates that the assay will detect the H7N9 viral subtype.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Centers for Disease Control and Prevention. Information for clinicians on influenza virus testing. Updated December 11. 2023. Accessed August 22, 2024. Available at www.cdc.gov/flu/professionals/diagnosis/index.htm
2. Centers for Disease Control and Prevention. Respiratory syncytial virus infection (RSV). Updated July 3, 2024. Accessed August 22, 2024. Available at https://www.cdc.gov/rsv/older-adults/index.html
3. Anderson NW, Binnicker MJ, Harris DM, et al. Morbidity and mortality among patients with respiratory syncytial virus infection: a 2-year retrospective review. Diagn Microbiol Infect Dis. 2016; 85(3):367-371
4. Boerger AC, Binnicker MJ. Comparison of the panther fusion respiratory panels to routine methods for detection of viruses in upper and lower respiratory tract specimens. Diagn Microbiol Infect Dis. 2020;97(2):115014
Method Description
Describes how the test is performed and provides a method-specific reference
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)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Sunday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.
CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
87631
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
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
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
---|---|---|
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 |
Test Setup Resources
Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.
Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.
SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.
Test Update Resources
Change Type | Effective Date |
---|---|
New Test | 2023-10-31 |