Brucella Total Antibody Confirmation, Agglutination, Serum
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Brucella are facultative intracellular, gram-negative staining bacilli capable of producing the disease "brucellosis" in humans. Human disease likely is acquired by contact with animals infected with the organism (Brucella abortus, Brucella suis, Brucella melitensis, and occasionally Brucella canis) either by direct contact or by ingestion of meat or milk. The signs and symptoms associated with brucellosis may include fever, night sweats, chills, weakness, malaise, headache, and anorexia. The physical examination may reveal lymphadenopathy and hepatosplenomegaly. A definitive diagnosis of brucellosis is made by recovering the organism from bone marrow, blood, fluid (including urine), or tissue specimens.
In cases of suspected brucellosis, serology may assist in the diagnosis and play a supplementary role to routine culture. Antibodies to Brucella species may not become detectable until 1 to 2 weeks following the onset of symptoms, so serum specimens drawn during acute disease may be negative by serology in patients with brucellosis. If serology is performed, the Centers for Disease Control and Prevention (CDC) currently recommends that specimens testing positive or equivocal for IgG or IgM by a screening EIA be confirmed by a Brucella-specific agglutination method.(1)
Evaluating patients with suspected brucellosis
The Centers for Disease Control and Prevention (CDC) recommends that specimens testing positive or equivocal for IgG or IgM by a screening EIA be confirmed by a Brucella-specific agglutination method.(1)
Negative to a titer of > or =1:40 can be seen in the normal, healthy population. A titer of > or =1:80 is often considered clinically significant(2); however, a 4-fold or greater increase in titer between acute and convalescent phase sera is required to diagnose acute infection.
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 drawn >2 weeks apart and studied at the same laboratory, or 3) Demonstration by immunofluorescence of Brucella species in a clinical specimen.
Positive results by a screening EIA 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.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
The tube agglutination assay was designed using antigen derived from Brucella abortus, and may not be positive in patients infected with other Brucella species (eg, Brucella canis).
Positive results by Brucella serology are not diagnostic of acute infection, as antibodies may persist for months to years following exposure. To diagnose acute infection, detection of Brucella species in culture is the recommended approach (see BRUCB / Brucella Culture, Blood).
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.
Clinical References Provides recommendations for further in-depth reading of a clinical nature
1. Public health consequences of a false-positive laboratory test result for Brucella-Florida, Georgia, and Michigan, 2005. MMWR Morb Mortal Wkly Rep 2008 June 6;57(22):603-605
2. Welch RJ, Litwin CM: A comparison of Brucella IgG and IgM ELISA assays with agglutination methodology. J Clin Lab Anal 2010;24:160-162