Assessment of diagnostic tests for bovine brucellosis: systematic review, development and validation
Brucella abortus; Accuracy; Diagnostic sensitivity; Diagnostic specificity; Cross-reactivity.
Bovine brucellosis, a zoonosis caused by Brucella abortus, represents a major health and economic problem, affecting both animal and public health. Accurate laboratory diagnosis is essential for surveillance, control and eradication programs, which mainly use serological tests due to their practicality and lower cost. Typically, these programs adopt a sequential approach, combining screening tests, such as the Rose Bengal Test (RBT) or the Buffered Plate Agglutination Test (BPAT), with confirmatory tests, such as the Complement Fixation Test (CFT), the Fluorescence Polarization Assay (FPA), the Enzyme-Linked Immunosorbent Assay (ELISA) and the 2-Mercaptoethanol (2-ME) Test. In recent years, studies on point-of-care tests, such as the lateral flow assay (LFA), have increased due to their applicability in the field. However, the variability in reported performances, the lack of standardization of protocols and cut-off points and the scarcity of robust comparative studies still limit the validation and widespread implementation of these methods in routine diagnostics. Therefore, this study aimed to validate and compare the accuracy (DSe and DSp) of different B. abortus antigens in an I-ELISA platform for the diagnosis of the disease, considering the interference of vaccine antigens and cross-reactions with antigens from other bacterial species, and also to conduct a systematic review to gather the different parameters used and evaluated in the development of lateral flow assays for the diagnosis of bovine brucellosis worldwide, to understand which variables are most important in the design of this diagnostic test.