用于在利什曼原虫（维安尼亚利什曼原虫）优势流行地区诊断皮肤利什曼病的墨西哥利什曼原虫（利什曼原虫）外抗原酶联免疫吸附测定法的现场验证
Field validation of a Leishmania (Leishmania) mexicana exo-antigens ELISA for diagnosing tegumentary leishmaniasis in regions of Leishmania (Viannia) predominance.
作者信息
Soares Killarney Ataide, Urdapilleta Ada Amália Ayala, Santos Gilcilene Maria dos, Carneiro Andréa Lisboa, Gomes Ciro Martins, Roselino Ana Maria, Sampaio Raimunda Nonata Ribeiro
机构信息
Pós-Graduação em Ciências Médicas, Universidade de Brasília (UnB), Brasília, DF, Brazil.
Escola Superior de Ciências da Saúde - ESCS, Faculdade de Medicina, Brasília, DF, Brazil.
出版信息
Braz J Infect Dis. 2015 May-Jun;19(3):302-7. doi: 10.1016/j.bjid.2015.03.010. Epub 2015 May 15.
BACKGROUND
Several tests are performed to obtain better accuracy when diagnosing American tegumentary leishmaniasis (ATL). It is believed that antigens released via secretion, excretion and metabolism are more specific than are antigens released by the lysis of Leishmania parasites. Such antigens are known as exo-antigens (exo-Ag) and are formed from products released by cultured parasites in a way that is similar to that in which they cause infections in hosts.
OBJECTIVE
We attempted to validate a Leishmania mexicana ELISA exo-Ag for ATL diagnosis in Midwestern Brazil.
METHODS
A total of 281 patients were included in the study. We analysed pre-treatment blood from 98 ATL patients; out of those, 85.7% and 14.3% had cutaneous and mucosal forms, respectively.
RESULTS
The exo-Ag accuracy was 83.99% (95% CI=79.24-87.81) with a sensitivity value of 90.82% (95% CI=83.46-95.09) and an overall specificity value of 80.33% (95% CI=73.97-85.44). The positive predictive value and negative predictive value were 71.20% (95% CI=62.72-78.41) and 94.23% (95% CI=89.40-96.94), respectively. Among healthy controls, exo-Ag had a specificity of 91.25% (95% CI=83.02-95.70); additionally, the test had specificity rates of 66.67% (95% CI=46.71-82.03) in Chagas disease patients, 60.61% (95% CI=43.68-75.32) in patients with rheumatic diseases, 76.92% (95% CI=49.74-91.82) in pemphigus foliaceus patients, 87.50% (95% CI=52.91-97.76) in leprosy patients, 87.50% (95% CI=63.98-96.50) in VRDL-positive patients, and 77.78 (95% CI=45.26-93.68) in deep mycosis patients.
CONCLUSION
Based on the indicators of validity, we conclude that the results obtained in this study enable the recommendation of the exo-Ag ELISA for ATL diagnosis once it presented a reasonable accuracy compared to classical methods. Cost evaluations are necessary to completely define the role of this technique in large scale.
背景
在诊断美洲皮肤利什曼病（ATL）时，需进行多项检测以提高诊断准确性。人们认为，通过分泌、排泄和代谢释放的抗原比利什曼原虫寄生虫裂解释放的抗原更具特异性。此类抗原被称为外抗原（exo-Ag），由培养的寄生虫释放的产物形成，其方式与它们在宿主中引起感染的方式相似。
目的
我们试图验证一种用于巴西中西部地区ATL诊断的墨西哥利什曼原虫ELISA外抗原检测方法。
方法
共有281名患者纳入本研究。我们分析了98例ATL患者治疗前的血液；其中，分别有85.7%和14.3%的患者为皮肤型和黏膜型。
结果
外抗原检测的准确性为83.99%（95%CI=79.24-87.81），灵敏度值为90.82%（95%CI=83.46-95.09），总体特异性值为80.33%（95%CI=73.97-85.44）。阳性预测值和阴性预测值分别为71.20%（95%CI=62.72-78.41）和94.23%（95%CI=89.40-96.94）。在健康对照中，外抗原检测的特异性为91.25%（95%CI=83.02-95.70）；此外，该检测在恰加斯病患者中的特异性率为66.67%（95%CI=46.71-82.03），在风湿性疾病患者中为60.61%（95%CI=43.68-75.32），在落叶型天疱疮患者中为76.92%（95%CI=49.74-91.82），在麻风病患者中为87.50%（95%CI=52.91-97.76），在梅毒血清反应阳性患者中为87.50%（95%CI=63.98-96.50），在深部真菌病患者中为77.78（95%CI=45.26-93.68）。
结论
基于有效性指标，我们得出结论，本研究获得的结果表明，与传统方法相比，外抗原ELISA检测具有合理的准确性，可推荐用于ATL诊断。需要进行成本评估以全面确定该技术在大规模应用中的作用。
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