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Comparison of a Brucella Enzyme Immunoassay and the Standard Agglutination with 2-Mercaptoethanol Test in the Diagnosis and Monitoring of Brucellosis in Mexican Patients by Juan Carlos Camacho-Martínez, María Judith Rios-Lugo, Darío Gaytán-Hernández, Héctor Hernández-Mendoza

Background: The diagnosis of human brucellosis is difficult based on clinical grounds alone. Thus, the diagnosis is based on microbiological and serological tests. Therefore, the diagnosis relies predominantly on laboratory testing. The objective of this study was to determine the most efficient test for the diagnosis and monitoring of patients treated for brucellosis by comparing the standard agglutination test in a tube with 2-mercaptoethanol (SAT-2Me) to an enzyme-linked immunosorbent assay for the detection of antibodies against Brucella IgM (IgM ELISA).
Methods: A retrospective chart review was performed. A total of 108 patients with brucellosis were analyzed at diagnosis and at the first and second follow-ups after treatment. The data were captured and analyzed using the SPSS 18.0 program. Frequencies, percentages, the Pearson’s chi-square test, the kappa coefficient, sensitivity, specificity, predictive values, odds ratio, and conditional odds ratio (OR and COR) were calculated.
Results: Diagnostic test: the IgM ELISA showed 96.3% sensitivity vs. 73.1% sensitivity for the SAT-2Me (p < 0.001). First follow-up: the IgM ELISA presented significant differences vs. the SAT-2Me in sensitivity (97.2% vs. 72.2%) and specificity (89.7% vs. 44.1%). Additionally, the second follow-up data showed significant differences in the sensitivity (85.7% vs. 71.4%) and specificity (82.8% vs. 41.4%) for the IgM ELISA vs. the SAT-2Me, re-spectively. In addition, the IgM ELISA showed significant concordance (0.836, p < 0.001 and 0.563, p < 0.001) at the first and second follow-ups, respectively, vs. the SAT-2Me.
Conclusions: The IgM ELISA is a more reliable and useful assay for the diagnosis and monitoring of brucellosis patients than the SAT-2 Me, avoiding up to 45.6% of unnecessary treatments. The SAT-2Me showed lower efficiency for diagnosis than the IgM ELISA and limited relevance for monitoring.

DOI: 10.7754/Clin.Lab.2020.190932