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Public health consequences of a false-positive laboratory test result for Brucella --- Florida, Georgia, and Michigan, 2005.

Human brucellosis, a nationally notifiable disease, is uncommon in the United States. Most human cases have occurred in returned travelers or immigrants from regions where brucellosis is endemic, or were acquired domestically from eating illegally imported, unpasteurized fresh cheeses. In January 20...

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Published in:MMWR: Morbidity & Mortality Weekly Report Vol. 57; no. 22; pp. 603 - 606
Format: case study Journal Article
Published: Centers for Disease Control & Prevention (CDC) 6/6/2008
Online Access:View this record in EBSCOhost
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      dt: 6/6/2008
      vid: 57
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      pub: Centers for Disease Control & Prevention (CDC)
      place: Atlanta, Georgia
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        atl: Public health consequences of a false-positive laboratory test result for Brucella --- Florida, Georgia, and Michigan, 2005.
      aug:
      sug:
        subj:
          Brucellosis Diagnosis
          Gram-Negative Aerobic Bacteria
          Public Health
          Adult
          Agglutination Tests
          False Positive Results
          Female
          Florida
          Georgia
          Immunoenzyme Techniques
          Michigan
          Adult: 19-44 years
          Female
      ab: Human brucellosis, a nationally notifiable disease, is uncommon in the United States. Most human cases have occurred in returned travelers or immigrants from regions where brucellosis is endemic, or were acquired domestically from eating illegally imported, unpasteurized fresh cheeses. In January 2005, a woman aged 35 years who lived in Nassau County, Florida, received a diagnosis of brucellosis, based on results of a Brucella immunoglobulin M (IgM) enzyme immunoassay (EIA) performed in a commercial laboratory using analyte specific reagents (ASRs); this diagnosis prompted an investigation of dairy products in two other states. Subsequent confirmatory antibody testing by Brucella microagglutination test (BMAT) performed at CDC on the patient's serum was negative. The case did not meet the CDC/Council of State and Territorial Epidemiologists' (CSTE) definition for a probable or confirmed brucellosis case, and the initial EIA result was determined to be a false positive. This report summarizes the case history, laboratory findings, and public health investigations. CDC recommends that Brucella serology testing only be performed using tests cleared or approved by the Food and Drug Administration (FDA) or validated under the Clinical Laboratory Improvement Amendments (CLIA) and shown to reliably detect the presence of Brucella infection. Results from these tests should be considered supportive evidence for recent infection only and interpreted in the context of a clinically compatible illness and exposure history. EIA is not considered a confirmatory Brucella antibody test; positive screening test results should be confirmed by Brucella-specific agglutination (i.e., BMAT or standard tube agglutination test) methods.
      pubtype: Academic Journal
      doctype:
        case study
        Journal Article
      ougenre: Article
    language: English
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