Instituto de Diagnóstico y Referencia Epidemiológicos, Francisco de P. Miranda 177, Lomas de Plateros, 01480, Mexico City, México.
Centro Nacional de Programas Preventivos y Control de Enfermedades, Mexico City, México.
Eur J Clin Microbiol Infect Dis. 2020 Mar;39(3):575-581. doi: 10.1007/s10096-019-03760-3. Epub 2020 Jan 20.
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.
布鲁氏菌病是一种主要发生在发展中国家的人畜共患病。世界卫生组织报告称，每年有 50 万例新发病例。2012 年至 2016 年，墨西哥报告了 13677 例病例，发病率为每 10 万人 2.00 至 2.64 例。为了分析墨西哥布鲁氏菌病的诊断算法，我们比较了商业实验室检测 ELISA、Brucellacapt®和侧向流动试验（LFT）在两个墨西哥地方性人群中的 473 名个体研究中的表现。所有患者均因出现疑似布鲁氏菌病的症状且无该病病史而在一级医疗单位接受治疗。收集临床流行病学信息，并采集初始血清样本以与抗布鲁氏菌抗体反应；随后在随访治疗就诊时采集样本。使用虎红平板试验，我们发现 165 份阴性样本和 308 份阳性反应样本，其中 222 例得到确诊，234 例至少在一个标志物（IgG 或 IgM）或 LFT 上呈阳性。使用 Brucellacapt®时，根据 Cohen's kappa 系数（κ）（0.813，95%置信区间 0.7788-0.8472），发现与常规算法观察到的结果相似。在常规算法和 ELISA 配对之间发现了相似的κ指数，0.7038（95%置信区间 0.6555-0.7521），表明两组诊断之间具有高度相似性。我们得出结论，常规血清诊断、Brucellacapt®和 LFT 结果不一致，彼此之间相关性差。相比之下，ELISA 检测对（IgG+IgM）与常规算法具有高度相关性，并且具有更高的正确阳性和阴性分类能力。
