Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias, Instituto René Rachou, Fundação Oswaldo Cruz, Belo Horizonte, Minas Gerais, Brasil.
Centro Federal de Educação Tecnológica de Minas Gerais, Contagem, Minas Gerais, Brasil.
PLoS Negl Trop Dis. 2019 Jul 18;13(7):e0007484. doi: 10.1371/journal.pntd.0007484. eCollection 2019 Jul.
Visceral leishmaniasis (VL) is the most severe form of leishmaniasis and is potentially fatal if not diagnosed and treated. Accurate and timely diagnosis is considered one of the pillars needed for the reduction in disease-related lethality. Brazil is currently one of the three eco-epidemiological hotspots for this disease. Several serological tests are commercially available in this country for VL diagnosis, although information on the performance of these tests is fragmented and insufficient. The aim of this study was to directly compare the performance of six commercial kits: three enzyme-linked immunosorbent assays (ELISAs), two immunofluorescence antibody tests (IFATs), one immunochromatographic test (ICT), besides one ICT, currently not commercially available in Brazil and one in-house direct agglutination test (DAT-LPC), not yet marketed.
METHODOLOGY/PRINCIPAL FINDINGS: A panel of 236 stored samples from patients with clinically suspected VL, including 77 HIV-infected patients, was tested. IT-LEISH and DAT-LPC showed the highest accuracy rate among the non-HIV-infected patients, 96.2% [CI95%: 92.8-99.7%] and 95.6% [CI95%: 91.9-99.3%], respectively. For the ELISA tests evaluated, the maximum accuracy was 91.2%, and in the inter HIV-status group analysis, no significant differences were observed. For both IFATs evaluated, the maximum accuracy was 84.3%, and a lower accuracy rate was observed among the HIV-infected patients (p = 0.039) than among the non-HIV-infected patients. The DAT-LPC was the most accurate test in the HIV-infected patients (p≤0.115). In general, no significant difference in accuracy was observed among the VL-suspected patients stratified by age.
CONCLUSIONS/SIGNIFICANCE: In summary, the differences in the performance of the tests available for VL in Brazil confirm the need for local studies before defining the diagnostic strategy.
内脏利什曼病（VL）是利什曼病中最严重的一种形式，如果不及时诊断和治疗，可能致命。准确及时的诊断被认为是降低疾病相关死亡率的支柱之一。巴西目前是该病的三个生态流行病学热点地区之一。该国目前有几种商业化的血清学检测方法可用于 VL 诊断，但有关这些检测方法性能的信息零散且不足。本研究旨在直接比较六种商业化试剂盒的性能：三种酶联免疫吸附试验（ELISA）、两种免疫荧光抗体试验（IFAT）、一种免疫层析试验（ICT），以及一种目前在巴西尚未商业化的 ICT 和一种内部直接凝集试验（DAT-LPC），尚未上市。
方法/主要发现：对 236 份来自临床疑似 VL 患者的储存样本进行了检测，包括 77 名 HIV 感染患者。在非 HIV 感染患者中，IT-LEISH 和 DAT-LPC 的准确性最高，分别为 96.2%[95%CI:92.8-99.7%]和 95.6%[95%CI:91.9-99.3%]。在评估的 ELISA 检测中，最高准确性为 91.2%，在 HIV 感染患者的组间分析中，未观察到显著差异。在评估的两种 IFAT 中，最高准确性为 84.3%，在 HIV 感染患者中观察到的准确性较低（p=0.039），而非 HIV 感染患者的准确性较低（p=0.039）。在 HIV 感染患者中，DAT-LPC 是最准确的检测方法（p≤0.115）。总体而言，按年龄分层的疑似 VL 患者的检测准确性无显著差异。
结论/意义：总之，巴西可用的 VL 检测方法的性能差异证实，在确定诊断策略之前，需要进行本地研究。
