Test ID: BRUGM
Brucella Antibody Screen, IgG & IgM, 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
Evaluating patients with suspected brucellosis
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| BRUTA | Brucella Ab, Agglutination, S | Yes | No |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
If Brucella antibody screen, IgG & IgM is positive or equivocal, then BRUTA/8112 Brucella Total Antibody Confirmation, Agglutination, Serum will be performed at an additional charge.
Method Name A short description of the method used to perform the test
BRUGM/89476: Enzyme-Linked Immunosorbent Assay (ELISA)
BRUTA/8112: Agglutination
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
Brucella Serology
Febrile Agglutinins (? FOR SPECIFIC TEST)
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: 2 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.
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 | 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 |
|---|---|---|
| Serum | Refrigerated (preferred) | 14 days |
| Frozen | 14 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Worldwide, brucellosis remains a major disease in humans and domesticated animals. Brucella infects goats (Brucella melitensis), cattle (Brucella abortus), swine (Brucella suis), and dogs (Brucella canis).(1) The disease has a limited geographic distribution. Few cases occur in the United States, with the bulk occurring in the Mediterranean region, Western Asia, and parts of Latin America and Africa.
Three species of Brucella commonly cause disease in humans: Brucella melitensis, Brucella suis, and Brucella abortus. The acute disease often presents with fever, chills, and malaise; the chronic form also causes abscesses in bone, brain, spleen, liver, and kidney.
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.
IgG SCREEN
Negative (reported as positive, negative, or equivocal)
IgM SCREEN
Negative (reported as positive, negative, or equivocal)
Interpretation Provides information to assist in interpretation of the test results
In the acute stage of the disease there is an initial production of IgM antibodies, followed closely by production of IgG antibodies. IgG-class antibodies may decline after treatment; however, high levels of circulating IgG-class antibodies may be found without any active disease. Chronic brucellosis shows a predominance of IgG-class antibodies with little or no detectable IgM.
Rising levels of specific antibody in paired sera can be regarded as serological evidence of recent infection. The presence of specific IgM in a single specimen may also indicate a recent infection, although IgM-class antibodies may persist for months following acute disease.
The Centers for Disease Control and Prevention (CDC) recommends that specimens testing positive for IgG or IgM by enzyme-linked immunosorbant assay (ELISA) be confirmed by a Brucella-specific agglutination method.(2)
The CDC/Council of State and Territorial Epidemiologists case definition for human brucellosis states that the laboratory criteria for diagnosis includes 1) Isolation of Brucella species from a clinical specimen, 2) Four-fold or greater rise in Brucella agglutination titer between acute- and convalescent-phase serum specimens obtained >2 weeks apart and studied at the same laboratory, or 3) Demonstration by immunofluorescence of Brucella species in a clinical specimen.
Positive results by ELISA that are not confirmed by Brucella-specific agglutination may represent false-positive screening results. If clinically indicated, a new specimen should be tested after 7 to 14 days.
If results of ELISA are negative and a recent infection is suspected, a new specimen should be tested after 7 to 14 days.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test utilizes antigen derived from Brucella abortus strain W99. However, significant cross-reactivity exists for other Brucella species and, therefore, the assays should not be used to differentiate infection at the species level.
Brucella canis, a rare cause of brucellosis, may not be detected by this method.
Detection of specific IgM or IgG-class antibody to Brucella melitensis and Brucella suis by this method has not been determined.
Enzyme-linked immunosorbent assay (ELISA) tests are intended to be used as a screen only. Positive results should be followed up using an agglutination assay for confirmation. Results must be used in conjunction with symptoms, patient history, and other clinical findings.
Supportive Data
According the manufacturer's package insert, 127 patient samples testing positive with the Rose-Bengal test were also examined with the Eurroimmun anti-Brucella abortus enzyme-linked immunosorbent assay (ELISA), and 160 blood donors were tested. Data from these studies were as follows for anti-Brucella abortus:
-IgG: sensitivity, 78.0%; specificity, 98.0%
-IgM: sensitivity, 56.0%; specificity, 98.0%
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Corbel MJ: Brucellosis: an overview. Emerg Infect Dis 1997;3:213-221
2. Public health consequences of a false-positive laboratory test result for Brucella--Florida, Georgia, and Michigan, 2005, MMWR Morb Mortal Wkly Rep June 6;2008/57(22);603-605
3. Araj GF, Lulu AR, Saadah MA, et al: Rapid diagnosis of central nervous system brucellosis by ELISA. J Neuroimmunol 1986;12:173-182
Method Description Describes how the test is performed and provides a method-specific reference
Serum is tested using an enzyme-linked immunosorbent assay (ELISA) Test Kit containing microtiter strips with wells coated with Brucella abortus antigens (strain W99). In the first reaction step, diluted patient samples are incubated in the wells. Specific IgG or IgM antibodies, if present in the serum, will bind to the antigens. To detect the bound antibodies, a second incubation is carried out using an enzyme-labeled antihuman IgG or antihuman IgM (enzyme conjugate). After addition of the substrate, tetramethylbenzidine (TMB)/hydrogen peroxide and a sulphuric acid stop solution, the resulting color reaction is measured photometrically at a wavelength of 450nm. (Package insert: Anti-Brucella abortus ELISA Test Instruction, Euroimmun Medizinische Labordiagnostika, Lubeck, Germany)
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, Wednesday, Friday; 9:00 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.
86622 x 2-Brucella antibody, IgG and IgM
86622-Brucella total antibody, agglutination (if appropriate)
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 |
|---|---|---|
| 23685 | Brucella Ab Screen, IgG, S | 24387-3 |
| 23686 | Brucella Ab Screen, IgM, S | 24388-1 |
| 23687 | Interpretation | 59464-8 |
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