Test ID: ROTA
Rotavirus Antigen, Feces
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
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
Investigation of patients with diarrhea, particularly infants, the elderly, and immunocompromised patients
Investigation of nosocomial diarrhea
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
See Parasitic Investigation of Stool Specimens Algorithm in Special Instructions.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
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
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.
Container/Tube:
Preferred: Sterile stool container
Acceptable: Swab
Specimen Volume: 5-10 g
Additional Information: Place specimen in a tightly-sealing plastic bag.
Forms: If not ordering electronically, submit a Microbiology Request Form (Supply T244) with the specimen.
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 | Grossly bloody (containing no visible stool) or very mucoid stool |
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 |
|---|---|---|
| Fecal | Frozen (preferred) | 7 days |
| Refrigerated | 72 hours |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Rotavirus infection produces a spectrum of responses that vary from subclinical infection, to mild diarrhea, to a severe and occasionally fatal dehydrating illness.
Rotavirus is the major cause of nonbacterial gastroenteritis, especially in infants and very young children (6 months-2 years of age). Among children hospitalized for gastroenteritis, up to 50% of the patient specimens will give positive rotavirus test results. The shedding of rotavirus in feces is fairly common among asymptomatic neonates. Endemic rotaviral infection is more likely to be symptomatic in babies who require special care than in healthy, full-term infants.
Rotaviruses pose a special threat to individuals who are immunosuppressed for bone marrow transplantation and to elderly persons, especially those living in nursing homes or other confined quarters. In other adults, rotavirus infections usually are subclinical.
In temperate climates, rotaviral infections are seasonal; they peak in frequency during the winter months and are uncommon during the summer. Rotaviral gastroenteritis has sometimes been called "winter vomiting disease." The disease is characterized by diarrhea of acute onset and a duration of 4 to 8 days. Vomiting is often the initial symptom. Some patients experience vomiting without diarrhea. Dehydration is the most common reason for hospitalization of patients infected with rotavirus.
Nosocomial transmission of rotavirus is often a costly and difficult problem to resolve; therefore, the rapid and accurate detection of rotavirus antigens may lead to better management of hospitalized patients.
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
Peak viral counts are reported to occur on days 3 to 5 after onset of symptoms. The virus is eliminated from the infected individual within a few days following acute infection. Specimens collected 8 days or more after onset of symptoms may not contain enough rotavirus antigen to produce a positive reaction.
A prolonged carrier state has been recognized with rotavirus infection.
The rate of positive test results may vary due to age, weather, seasonal factors, geographic location, and the general health environment for the group under study.
See Parasitic Investigation of Stool Specimens Algorithm in Special Instructions for other diagnostic tests that may be of value in evaluating patients with diarrhea.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Stool specimens should be collected as soon after onset of symptoms as possible.
Do not collect specimens in containers having media, preservatives, animal serum, or detergent as any of these may interfere with the assay.
This assay does not preclude the presence of other pathogenic organisms. While the relationship between rotavirus and gastroenteritis is well established, coinfection with bacterial pathogens is possible. Bacterial testing should be performed in parallel with the rotavirus antigen test to rule out bacterial etiology of the illness.
Results of the rotavirus antigen assay must be interpreted with caution. A negative result does not exclude the possibility of rotavirus infection, as too small a quantity of virus or inadequate or improper sampling may cause a false-negative result.
Supportive Data
This EIA antigen detection method has 100% sensitivity and 92% specificity when compared to transmission electron microscopy (EM), the method initially used to detect virus in fecal and intestinal biopsy specimens and the standard to which rotavirus diagnostic tests are compared. When compared to EM and RNA analysis, in combination, the specificity increases to 97%.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
Mitchell DK, Jiang X, Matson DO: Gastrointestinal infections. In Essentials of Diagnostic Virology. Edited by GA Storch, Churchill Livingstone. 2000 pp 82-84
Method Description Describes how the test is performed and provides a method-specific reference
This FDA-approved kit utilizes monoclonal antibodies in a solid-phase sandwich type EIA. Plastic microtiter wells are coated with a monoclonal antibody directed against the product of the sixth viral gene (VP6), which is the group-specific antigen for all known human rotaviruses. An aliquot of fecal suspension is added to the well and incubated simultaneously with an anti-rotavirus monoclonal antibody conjugated to horseradish peroxidase, resulting in the rotavirus antigen being sandwiched between the solid-phase and enzyme-linked antibodies. After 60 minutes incubation at ambient temperature, the specimen well is washed in order to remove unbound enzyme-labeled antibodies. Enzyme substrate (urea peroxidase) and chromogen tetra methylbenzidine (TMB) are added to the wells and incubated for 10 minutes at ambient temperature. The enzyme bound in the wells converts the colorless substrate to a blue color. The intensity of the blue color is directly proportional to the concentration of rotavirus antigen in the specimen. (Package insert: Premier Rotaclone Steele AD, Williams MM, Bos P, Peenze I: Comparison of two rapid enzyme immunoassays with standard enzyme immunoassay and latex agglutination for the detection of human rotavirus in stools. J Diarrhoeal Dis Res 1994;12:117-120)
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.
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.
87425
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 |
|---|---|---|
| 24082 | Rotavirus Ag, F | 5880-0 |
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