Test ID: RSVAN
Respiratory Syncytial Virus (RSV) Antigen
NY State Approved 
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Rapid identification of patients with respiratory syncytial virus (RSV) infections
Detection of RSV antigen from nasopharyngeal specimens
Method Name A short description of the method used to perform the test
Enzyme Immunoassay (EIA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
RSV Ag, Nasopharyn MMLNE only
RSV, ELISA
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.
Specimens from approved sources that are submitted from children age 5 years or older will be resulted with a disclaimer.
Specimen Sources:
Preferred: Nasopharyngeal aspirate
Acceptable: Nasopharyngeal wash, nasopharyngeal swab, or nasal wash
Container/Tube: Sterile container
Specimen Volume: >1 mL
Collection Instructions: Nasopharyngeal swab is acceptable but is inferior to aspirate or wash.
Additional Information: Specimen source is required.
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.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Varies | Frozen (preferred) | 7 days |
| Refrigerated | 24 hours |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Acute respiratory disease caused by respiratory syncytial virus (RSV) is a particularly debilitating infection in infants and young children. The usual manifestations are upper respiratory disease with rhinitis and fever, which often progress to bronchiolitis, pneumonia, or both in primary infections, especially in infants <6 months of age. Hospitalization is considered early in the course of the disease in infants at risk for severe RSV infections, such as infants with congenital heart disease or bronchopulmonary dysplasia.
The conventional method for laboratory diagnosis of RSV infection has been the inoculation of cell cultures with detection of characteristic cytopathic effects after several days incubation (range, 3-14 days). The efficiency of this method is hampered by the lability of the virus in transit to the laboratory and the lack of sensitivity of cell lines to produce infection with the virus.
Direct testing for RSV antigen is rapid, sensitive, and specific when compared to cell culture methods. With the availability of ribavirin therapy for serious RSV infections, rapid diagnostic tests for this virus have become increasingly important.
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.
Negative
Interpretation Provides information to assist in interpretation of the test results
Compared to tissue culture, the sensitivity of the respiratory syncytial virus (RSV) antigen assay is 93% to 97%, and the specificity is 90% to 97%.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
The etiology of respiratory infection caused by microorganisms other than respiratory syncytial virus (RSV) will not be established with this test.
This assay is capable of detecting both viable and non-viable RSV particles.
Test performance depends on antigen load and may not correlate with tissue culture performed on the same specimen.
It has been previously established that fresh specimens are preferable to frozen for RSV testing. Suboptimal test performance may result with the latter. Fresh specimens should be transported to the laboratory as rapidly as possible. Nasal washes may be stored refrigerated (2-8 degrees C) for up to 24 hours, eluted nasopharyngeal swabs for up to 48 hours refrigerated, or both can be frozen at -20 degrees C for up to 1 week prior to processing.
Inadequate specimen collection, improper specimen handling or transport, or low levels of virus shedding, may yield a false-negative result. Accordingly, a negative test result does not eliminate the possibility of an RSV infection. Patient diagnosis should always include laboratory test results in concert with all other clinical information available.
The rate of positivity observed will vary, depending on the method of specimen collection, handling and transport system employed, time of year, age of the patient, geographic location, and most importantly, local disease prevalence.
Throat swabs are not acceptable.
Excessively mucoid specimens may fail to be absorbed into the test membrane or may yield uninterpretable results.
Specimens containing blood have been found to yield uninterpretable or false-positive results.
Assay performance characteristics not established for use on specimens from patients > or =5 years old. Interpret results in conjunction with clinical findings.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Falsey AR, Walsh EE: Respiratory syncytial virus infection in adults. Clin Microbiol Rev 2000;13:371-384
2. Staat MA: Respiratory syncytial virus infections in children. Semin Respir Infect 2002;17:15-20
3. Swenson PD, Kaplan MH: Rapid detection of respiratory syncytial virus in nasopharyngeal aspirates by a commercial enzyme immunoassay. J Clin Microbiol 1986;23:485-488
Method Description Describes how the test is performed and provides a method-specific reference
The test system is an immunochromatographic membrane assay used to detect respiratory syncytial virus (RSV) fusion protein antigen. Sample to be tested is added to a pad at the top of the test strip. RSV antigen present in the sample reacts to bind anti-RSV conjugated antibody. The resulting antigen-conjugate complexes are captured by immobilized anti-RSV antibody, forming the sample line. Immobilized control line antibody captures a visualizing conjugate, forming a pink control line. Test results are interpreted by the presence or absence of visually detectable pink-to-purple colored lines when read after 15 minutes incubation.(Package insert: Binax NOW RSV, rev 10, 2/6/09)
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 Friday, Sunday; 3rd shift; STAT availability
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.
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.
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.
87807
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 |
|---|---|---|
| 11002 | RSV Antigen | 68966-1 |
External
link
PDF
document
Excel
document
Word
document