Respiratory Syncytial Virus (RSV), Molecular Detection, PCR
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Rapid and accurate detection of respiratory syncytial virus
Multiplex Real-Time Polymerase Chain Reaction (RT-PCR)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Respiratory Syncytial Virus, PCR
Respiratory Syncytial Virus (RSV)
RSV (Respiratory Syncytial Virus)
Syncytial, Respiratory Virus
RSV (Respiratory Syncytial Virus)
Syncytial, Respiratory Virus
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Forms: If not ordering electronically, submit a Microbiology Request Form (Supply T244) with the specimen.
Specimen source is required.
Submit only 1 of the following specimens:
Specimen Type: Nasal or nasopharyngeal aspirate
Container/Tube: Sterile container
Specimen Volume: 0.5 mL
Specimen Type: Nasopharyngeal or throat
Container/Tube: Nasopharyngeal swab (rayon mini-tip swab) or throat swab
Specimen Volume: Swab
Additional Information: Swab may be placed in M5 media for transport.
Specimen Type: Nasopharyngeal washing, bronchial washing, bronchial brushing, or bronchoalveolar lavage
Container/Tube: Sterile container
Specimen Volume: 0.5 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Bronchial washing, bronchoalveolar lavage, or nasal or nasopharyngeal aspirate or washing: 0.3 mL
Calcium alginate-tipped swab, wood swab, or transport swab containing gel
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Respiratory syncytial virus (RSV) is a respiratory virus that infects the respiratory system and can cause an influenza-like illness. Most otherwise healthy people recover from RSV infection in 1 to 2 weeks. However, 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 under 1 year of age in the United States, and is more frequently being recognized as an important cause of respiratory illness in older adults.
RSV RNA can be detected by PCR in respiratory secretions, including upper and lower respiratory specimens. Nasopharyngeal swabs or aspirates are the preferred specimen types for detection of RSV RNA. Nasal swabs have been shown to provide equivalent yield to nasopharyngeal specimens for molecular detection of influenza A and B RNA, but not RSV RNA.(1,2) Tracheal aspirates are generally not acceptable for testing due to the viscous nature of these specimens.
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.
A positive test result indicates that the patient is presumptively infected with respiratory syncytial virus. The test does not indicate the stage of infection. Laboratory test results should always be considered in the context of clinical observations and epidemiologic data in making a final diagnosis.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Given that influenza A and B and respiratory syncytial virus (RSV) can cause identical appearing clinical illness, this test should typically be ordered as a panel that includes both influenza A/B and RSV (#60552 Influenza Virus Type A and Type B, and Respiratory Syncytial Virus (RSV), Molecular Detection, PCR).
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. Nasopharyngeal swabs or aspirates are the preferred specimen types and are optimal for detection of RSV RNA. However, the test is validated for use with most upper and lower respiratory specimens, including nasal swabs, throat swabs, bronchoalveolar lavage specimens, and bronchial brushings/washings. Tracheal aspirates are not acceptable for testing due to the viscous nature of these specimens.
This test should not be performed unless the patient meets clinical and epidemiologic criteria for testing.
The test is specific for RSV; therefore, the results do not exclude the possibility of infection with other respiratory viruses. Influenza C virus is not detected by this assay.
Negative results do not preclude infection with RSV and should not be used as the sole basis for treatment or other patient management decisions.
This assay detects both viable and nonviable virus. Test performance depends on viral load in the specimen and may not correlate with cell culture performed on the same specimen.
Performance of the assay has not been established for monitoring antiviral treatment or duration of infection with RSV and influenza viruses.
All testing was performed on the Roche LightCycler 480 instrument using the Prodesse ProFlu+ test for influenza A, influenza B, and respiratory syncytial virus (RSV).
A total of 113 clinical specimens were tested by this Prodesse ProFlu+ Assay and the BinaxNow RSV antigen card test. Discrepant specimens were tested by a laboratory-developed RSV PCR assay targeting the nucleocapsid gene. Of these, 89 specimens were positive by both methods and 9 were negative by both. A total of 14 specimens were detected by the BinaxNow test that were not detected by the ProFlu+ PCR, but only 7 of these were positive by additional PCR testing (final sensitivity=93%). One specimen was detected by the ProFlu+ PCR and not the BinaxNow test.
-Qualitative intra-assay precision=100%; standard deviation <0.9 PCR cycles
-Qualitative interassay=98%; standard deviation <0.9 PCR cycles
Limit of detection (LoD):
-The LoD using a quantified plasmid standard was 10 targets/microliter for swab respiratory specimens, and 25 targets/microliter for nonswab specimens.
-The LoD using quantitated cells cultures was 10 TCID50/mL for RSV.
No cross-reactivity observed using a panel of 34 viruses, bacteria, fungi, and mycobacteria that may be found in respiratory specimens.
No inhibition was seen in any of the extracted lower or upper respiratory specimens when tested at the LoD.
A review of the literature indicates that the reference range is "negative" for this assay. This assay is designed to detect RSV and is to be used for patients with a clinical history and symptoms consistent with this disease. This test should not be used to screen healthy patients.
This is a qualitative assay and results are reported as negative or positive for RSV.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Meerhoff TJ, Houben ML, Coenjaerts FE, et al: Detection of multiple respiratory pathogens during primary respiratory infection: nasal swab versus nasopharyngeal aspirate using real-time polymerase chain reaction. Eur J Clin Microbiol Infect Dis 2010;29:365-371
2. Heikkinen T, Marttila J, Salmi AA, Ruuskanen O: Nasal swab versus nasopharyngeal aspirate for isolation of respiratory viruses. J Clin Microbiol 2002;40(11):4337-4339
Method Description Describes how the test is performed and provides a method-specific reference
The Prodesse ProFlu+ assay is a real-time, reverse-transcription PCR (rRT-PCR) assay for detection of respiratory syncytial virus (RSV). This assay is modified from the U.S Food and Drug Administration-approved version by use of an alternate amplification system (Roche LightCycler 480). Viral nucleic acid is extracted by the MagNA Pure automated instrument (Roche Applied Science) from upper and lower respiratory specimens, including nasal, throat, and nasopharyngeal swabs, bronchoalveolar lavage, nasopharyngeal aspirates, and bronchial washings and brushings. Reverse transcription produces cDNA from RNA in the extracted specimen, which is then amplified and detected by use of Taqman probes on the Roche LightCycler 480 instrument. Positive results are detected when a fluorescent signal is generated that crosses the threshold of background fluorescence. (Unpublished Mayo method)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Sunday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Same day/1 day
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
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 The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) 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.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|32286||Respiratory Syncytial Virus, PCR||40988-8|