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内脏利什曼病流行地区用于犬类血清学诊断的DPP(®) CVL快速检测的比较评估

Comparative evaluation of the DPP(®) CVL rapid test for canine serodiagnosis in area of visceral leishmaniasis.

作者信息

Laurenti M D, de Santana Leandro M V, Tomokane T Y, De Lucca H R L, Aschar M, Souza C S F, Silva R M, Marcondes M, da Matta V L R

机构信息

Laboratory of Pathology of Infectious Diseases (LIM50), Medical School, University of São Paulo, São Paulo (SP), Brazil.

Laboratory of Pathology of Infectious Diseases (LIM50), Medical School, University of São Paulo, São Paulo (SP), Brazil.

出版信息

Vet Parasitol. 2014 Oct 15;205(3-4):444-50. doi: 10.1016/j.vetpar.2014.09.002. Epub 2014 Sep 16.

Abstract

We investigated the performance of the DPP(®) canine visceral leishmaniasis (CVL) rapid test, a novel immunochromatographic assay launched by BioManguinhos (Brazil), which was recently included in the new Brazilian protocol for screening CVL in serological surveys. The present study compared the DPP(®) with the ELISA and IFA produced by BioManguinhos (Brazil) both with L. major-like antigens and with in-house tests using Leishmania infantum chagasi (in-house ELISA and in-house IFA). We analyzed the sera from clinically symptomatic (n=47) and asymptomatic (n=38) infected dogs from an endemic area of CVL, as well as from healthy (n=18) dogs, in addition to the sera of dogs (n=81) infected with other pathogens. The DPP(®) and the in-house ELISA showed a sensitivity of 90.6% and 94.1%, respectively, and specificity of 95.1% and 97.5%, respectively, and both presented cross-reactivity only with the sera of dogs with babesiosis, 44% for the DPP(®) and 22% for the in-house ELISA. The clinical groups were detected equally by the two assays. The ELISA BioManguinhos, IFA BioManguinhos, and in house-IFA showed a good sensitivity, 90.6%, 96.5% and 89.4%, respectively, but very low specificity, 77.8%, 69.1% and 65.8%, respectively, due to the high cross-reactivity with the sera from the animals harboring other pathogens. The in-house ELISA provided the highest accuracy (95.8%), followed by the DPP(®) (92.7%), ELISA BioManguinhos (84.3%), IFA BioManguinhos (83.1%), and in-house IFA (78.0%). The simultaneous use of the DPP(®) and ELISA BioManguinhos reached a sensitivity of 99.1% and 82.1% when used sequentially. In conclusion, the DPP(®) performed well as serological test for CVL, and detected both asymptomatic and symptomatic dogs in equal proportions. Although its sensitivity is not ideal yet, discarding the IFA and including the DPP(®) improved the accuracy of the new Brazilian CVL diagnostic protocol, particularly of detecting truly infected dogs. Moreover, considering the higher specificity of DPP(®) (95.1% vs 77.8%), positive predictive value (95.1% vs 81.1%) and positive likelihood value (18.3% vs 4.1%) in comparison with the ELISA BioManguinhos, the use of DPP(®) as a confirmatory test instead of a screening test is suggested.

摘要

我们对DPP(®)犬内脏利什曼病(CVL)快速检测进行了研究,这是巴西BioManguinhos推出的一种新型免疫层析检测法,最近被纳入巴西新的血清学调查中CVL筛查方案。本研究将DPP(®)与BioManguinhos(巴西)生产的ELISA和IFA进行了比较,二者均使用类硕大利什曼原虫抗原以及使用婴儿利什曼原虫恰加斯株的内部检测方法(内部ELISA和内部IFA)。我们分析了来自CVL流行地区临床有症状(n = 47)和无症状(n = 38)感染犬的血清,以及健康犬(n = 18)的血清,此外还分析了感染其他病原体的犬(n = 81)的血清。DPP(®)和内部ELISA的敏感性分别为90.6%和94.1%,特异性分别为95.1%和97.5%,二者均仅与巴贝斯虫病犬的血清出现交叉反应,DPP(®)为44%,内部ELISA为22%。两种检测方法对临床组的检测效果相同。BioManguinhos ELISA、BioManguinhos IFA和内部IFA的敏感性分别为90.6%、96.5%和89.4%,但特异性非常低,分别为77.8%、69.1%和65.8%,因为与携带其他病原体动物的血清交叉反应性高。内部ELISA的准确性最高(95.8%),其次是DPP(®)(92.7%)、BioManguinhos ELISA(84.3%)、BioManguinhos IFA(83.1%)和内部IFA(78.0%)。顺序使用DPP(®)和BioManguinhos ELISA时,敏感性分别达到99.1%和82.1%。总之,DPP(®)作为CVL的血清学检测方法表现良好,能以相同比例检测出无症状和有症状的犬。尽管其敏感性尚不理想,但舍弃IFA并纳入DPP(®)提高了巴西新CVL诊断方案的准确性,尤其是在检测真正感染犬方面。此外,考虑到与BioManguinhos ELISA相比,DPP(®)具有更高的特异性(95.1%对77.8%)、阳性预测值(95.1%对81.1%)和阳性似然比(18.

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