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Evaluation of serological diagnostic tests of human brucellosis for prevention and control in Mexico

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Abstract

Brucellosis is a zoonosis mainly present in developing countries. The WHO reports 500,000 new cases every year. From 2012 to 2016, 13,677 cases were reported in Mexico, with 2.00 to 2.64 rate per 100,000 inhabitants. To analyze the diagnostic algorithm of brucellosis in Mexico, we compared the commercial laboratory tests ELISA, Brucellacapt®, and lateral flow test (LFT) in a study of 473 individuals from two endemic Mexican populations. All patients were treated in first-level medical units for presenting brucellosis compatible symptoms and without a history of the disease. Clinical-epidemiological information was gathered and initial serum samples were obtained to react with anti-Brucella antibodies; subsequent samples were collected at follow-up treatment visits. Using the Rose Bengal screening, we found 165 negative samples and 308 positive reactive samples, of which 222 cases were confirmed and 234 were positive on at least one marker (IgG or IgM) or LFT. When Brucellacapt® was used, similar results to those observed with the conventional algorithm were found as judged by the Cohen’s kappa coefficient (κ) (0.813, 95% CI 0.7788–0.8472). Similar κ indices between conventional algorithm and ELISA pair were found, 0.7038 (95% CI 0.6555–0.7521), representing high similarity between both groups of diagnosis. We conclude that conventional serodiagnoses, Brucellacapt® and LFT, presented inconclusive results and poor correlation between them. By contrast, ELISA test pair (IgG + IgM) presented high correlation with the conventional algorithm and greater capacity for correct positive and negative classification.

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Acknowledgments

The project was partially supported by The United States Centers for Disease Control and Prevention (CDC). The authors thank Dr. Martha Guerra and Dr. Maria Negron (CDC) for their assistant in the elaboration of the study protocol, field study implementation, and data analysis. We are grateful of the management staff and chemistry analysts at LESPs for handling and processing samples and formats; finally, we are thankful to Dr. Jesús Bautista Olvera, head of the Blood Bank of Juárez Hospital of Mexico, for his donation of control sera.

Funding

The project was partially supported by BIDS (Border Infectious Disease Surveillance) project of Centre for Disease Control and Prevention (CDC) from United States.

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Authors

Contributions

FVP, CGB, and IHM developed study proposal; FVP, CGB, IHM, and BSJ, prepare protocol and participate in study design; BSJ, LB, CGB, and DR perform laboratory tests and develop databases; CGB, BSJ, SPS, FVP, JMH, and DR accomplish data analysis; and CGB, BSJ, JADQ, and JMH wrote reports and this manuscript.

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Correspondence to Carmen Guzmán-Bracho.

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The study was approved by the Ethics and Research Committee of the General Directorate of Epidemiology, Health Ministry of Mexico.

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Guzmán-Bracho, C., Salgado-Jiménez, B., Beltrán-Parra, L.G. et al. Evaluation of serological diagnostic tests of human brucellosis for prevention and control in Mexico. Eur J Clin Microbiol Infect Dis 39, 575–581 (2020). https://doi.org/10.1007/s10096-019-03760-3

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  • DOI: https://doi.org/10.1007/s10096-019-03760-3

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