Test ID: RB
Rubella Antibodies, IgG, Serum
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
Determination of rubella immune status
Method Name A short description of the method used to perform the test
Enzyme-Linked Immunosorbent Assay (ELISA)
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
MMR
Prenatal Profile (includes 6 tests)
RBG
Rubella Ab, IgG Only, S
Rubella Antibodies (order if >6 mo)
Rubella Antibodies, IgG, Serum
Rubella Screen, Serum
Serol,Rubella(S)
Three-Day Measles
Torch -> if pt >6 mo order:
TORCH
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: Red top
Acceptable: Serum gel
Specimen Volume: 0.5 mL
Forms: If not ordering electronically, submit a General Request Form (Supply T239) 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 | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | Mild OK; Gross reject |
| 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 |
|---|---|---|
| Serum | Refrigerated (preferred) | 14 days |
| Frozen | 14 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Primary postnatal rubella infection (German or 3-day measles) is typically a mild, self-limiting disease characterized by a maculopapular rash, fever, malaise, and lymphadenopathy.
Conversely, primary prenatal rubella infections may have devastating results. In utero infections may severely damage the fetus, particularly if the infection occurs during the first 4 months of gestation. Congenitally infected infants may exhibit 1 or more defects including congenital heart disease and mental retardation.
Prior to the introduction of the rubella vaccines, approximately 15% of childhood sensorineural deafness and 2% of congenital heart defects were attributed to congenital rubella infection in both the United States (US) and the United Kingdom. During the epidemic of 1962 to 1965, rubella infections during pregnancy were estimated to have caused 30,000 stillbirths and 20,000 malformed infants in the US.
The US rubella vaccination program, which calls for vaccination of all children, has significantly reduced the incidence of rubella. A total of 9 cases of rubella were reported to the CDC in 2004, and only 4 cases of congenital rubella syndrome were reported between 2001 and 2004.(3) Due to the success of the national vaccination program, rubella is no longer considered endemic in the US (cdc.gov/rubella).
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
Approximately 80% to 90% of the United States (US) adult population shows serologic evidence of immunity to rubella. The rubella vaccine is recommended for all children, as well as nonimmune adolescents and adults (particularly females) unless it is specifically contraindicated. Due to the national vaccination program, the majority of the US population will be positive for rubella IgG.
A positive result indicates either prior exposure to the virus or response to vaccination. The presence of rubella IgG suggests immunity against rubella.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This assay should only be used as a means of determining the immune status of an individual through the detection of antirubella IgG-class antibodies.
The presence of antirubella IgG antibodies does not exclude the possibility of a recent or ongoing infection. Testing for IgM-class antibody to rubella should be performed at a state health laboratory or at the CDC if the clinical presentation is suggestive of acute rubella infection.
Supportive Data
Among 110 normal donor serum specimens tested, 106 (96.4%) were positive by this SeraQuest Rubella IgG enzyme-linked immunosorbent assay.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Yelland MJ: Rubella immune status in general practice. Aust Fam Physician 1989;18:1279-1281;1284-1285
2. Recommendation of the Immunization Practices Advisory Committee: Centers for Disease Control Morbidity and Mortality Weekly Report 1981;30:37-47
3. Achievements in Public Health: elimination of rubella and congenital rubella syndrome – United States, 1969-2004: Centers for Disease Control Morbidity and Mortality Weekly Report, March, 2005;54(11):279-282
Method Description Describes how the test is performed and provides a method-specific reference
This is an enzyme-linked immunosorbent assay. Diluted samples are incubated in antigen-coated (rubella antigen strain HPV-77) wells. Rubella antibodies, if present, are immobilized in the wells. Excess sample is removed with a wash step and conjugate is added and incubated. If IgG antibodies to rubella are present, the conjugate will be immobilized in the wells. Excess conjugate is removed with a second wash step. Substrate is added and incubated. The substrate is converted to a yellow end product, which is read photometrically.(Package insert: SeraQuest Rubella IgG Test Kit. SeraQuest, North Miami FL)
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; 9 a.m.
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.
86762
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 |
|---|---|---|
| RB | Rubella Ab, IgG, S | 40667-8 |
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