Hospital-based evidence on cost-effectiveness of brucellosis diagnostic tests and treatment in Kenyan hospitals

Hospitals in Kenya continue to use the Febrile Antigen Brucella Agglutination Test (FBAT) to diagnose brucellosis, despite reports showing its inadequacy. This study generated hospital-based evidence on the performance and cost-effectiveness of the FBAT, compared to the Rose Bengal Test (RBT).Twelve hospitals in western Kenya stored patient serum samples that were tested for brucellosis using the FBAT, and these were later re-tested using the RBT. Data on the running time and cost of the FBAT, and the treatment prescribed for brucellosis, were collected. The cost-effectiveness of the two tests, defined as the cost in US Dollars ($) per Disability Adjusted Life Year (DALY) averted, was determined, and a basic sensitivity analysis was run to identify the most influential parameters. Over a 6-month period, 180 patient serum samples that were tested with FBAT at the hospitals were later re-tested with RBT at the field laboratory. Of these 24 (13.3%) and 3 (1.7%) tested positive with FBAT and RBT, respectively. The agreement between the FBAT and RBT was slight (Kappa = 0.12). Treatment prescribed following FBAT positivity varied between hospitals, and only one hospital prescribed a standardized therapy regimen. The mean $/DALY averted when using the FBAT and RBT were $2,065 (95% CI $481-$6,736) and $304 (95% CI $126-$604), respectively. Brucellosis prevalence was the most influential parameter in the cost-effectiveness of both tests. Extrapolation to the national level suggested that an estimated $338,891 (95% CI $47,000-$1,149,000) per year is currently spent unnecessarily treating those falsely testing positive by FBAT. These findings highlight the potential for misdiagnosis using the FBAT. Furthermore, the RBT is cost-effective, and could be considered as the mainstay screening test for human brucellosis in this setting. Lastly, the treatment regimens must be harmonized to ensure the appropriate use of antibiotics for treatment.Author summary: Brucellosis is the most common bacterial zoonosis globally, with a higher burden in low-resource settings. In humans, the disease manifests itself with non-specific clinical signs, and current international guidelines recommend the use of two serological diagnostic tests to make a confirmatory diagnosis. Many hospitals in Kenya and some neighbouring countries have been using the Febrile Antigen Brucella Agglutination Test (FBAT) for diagnosis, despite reports showing its poor performance. In this study we compared the diagnostic performance and cost-effectiveness of the FBAT with that of the Rose Bengal Test (RBT), a serological assay recommended by international guidelines. Our results showed that, compared to the RBT, the FBAT incorrectly diagnosed a number of patients. This is of concern as it leads to unnecessary antibiotic treatments, increasing the economic burden of the disease and exacerbating the risk of antibiotic resistance. We also highlight the discrepancies in brucellosis treatment regimens currently being prescribed by various hospitals. Finally, we showed that the RBT is a more cost-effective diagnostic test. Our recommendation, therefore, is for the RBT to be considered as the mainstay diagnostic test for human brucellosis in all Kenyan hospitals, and for the harmonization of treatment guidelines.