Test Catalog

Test Id : ROTA

Rotavirus Antigen, Feces

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 situations when tests are added to the initial order. This includes reflex and additional tests.

See Laboratory Testing for Infectious Causes of Diarrhea in Special Instructions for other tests that may be useful in the evaluation of a patient with diarrhea.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Enzyme Immunoassay (EIA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Rotavirus Ag, F

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Laboratory Testing for Infectious Causes of Diarrhea in Special Instructions for other tests that may be useful in the evaluation of a patient with diarrhea.

Specimen Type
Describes the specimen type validated for testing

Fecal

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Stool Collection Kit, Random (T635)

Container/Tube:

Preferred: Sterile fecal container

Acceptable: Swab

Specimen Volume: 5-10 g

Collection Instructions: Place specimen in a tightly sealed plastic bag.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

1 g

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Other Grossly bloody (containing no visible feces) Very mucoid feces

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
Fecal Frozen (preferred) 7 days
Refrigerated 72 hours

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 situations when tests are added to the initial order. This includes reflex and additional tests.

See Laboratory Testing for Infectious Causes of Diarrhea in Special Instructions for other tests that may be useful in the evaluation of a patient with diarrhea.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Rotavirus is a major cause of nonbacterial gastroenteritis, especially in infants and very young children (6 months-2 years of age) who have not received the rotavirus vaccine. Infection may be entirely asymptomatic or produce a spectrum of disease ranging from mild gastroenteritis to severe diarrhea and vomiting with dehydration. Infection usually begins acutely and lasts for 4 to 8 days. In temperate climates, rotaviral infections are seasonal; they peak in frequency during the winter months and are uncommon during the summer. Rotaviral gastroenteritis is, therefore, sometimes called "winter vomiting disease."

 

Infection is more likely to be symptomatic in preterm infants, immunosuppressed patients, and elderly individuals, especially those living in nursing homes or other confined quarters. In other children and adults, rotavirus infections are usually subclinical and may be associated with asymptomatic shedding of rotavirus in the feces.

 

Rapid and accurate detection of rotavirus antigens in fecal specimens may lead to better patient management, particularly in hospitalized or institutionalized 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 Laboratory Testing for Infectious Causes of Diarrhea 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

Fecal 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.

 

A positive result does not preclude the presence of other pathogenic organisms. While the relationship between rotavirus and gastroenteritis is well established, coinfection with bacterial or parasitic pathogens is possible. If suspected, testing for other enteric pathogens should be performed in parallel with the rotavirus antigen test.

 

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
Recommendations for in-depth reading of a clinical nature

Centers for Disease Control and Prevention: Rotavirus. Accessed 4/23/2018. Available at www.cdc.gov/rotavirus/index.html

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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 EIA for detection of Rotavirus Antigen in Human Fecal Samples. January 2015)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

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 Saturday

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.

1 to 2 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Until reported

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

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 Regional Manager. 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 cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified 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 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.

87425

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
ROTA Rotavirus Ag, F 5880-0
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.
24082 Rotavirus Ag, F 5880-0

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.

Excel | Create a PDF

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

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.

SI Normal Reports | SI Abnormal Reports