Druzian Angelita Fernandes, França Adriana de Oliveira, Higa-Júnior Minoru German, Dorval Maria Elizabeth Cavalheiros, Lima-Junior Manoel Sebastião da Costa, Pompilio Mauricio Antonio, Matos Maria de Fatima Cepa, de Carvalho Lídia Raquel, Mendes Rinaldo Poncio, Paniago Anamaria Mello Miranda
Maria Aparecida Pedrossian University Hospital, Federal University of Mato Grosso do Sul, Campo Grande, Mato Grosso do Sul, Brazil; Graduate Program in Infectious and Parasitic Diseases, Federal University of Mato Grosso do Sul, Campo Grande, Mato Grosso do Sul, Brazil.
Graduate Program in Infectious and Parasitic Diseases, Federal University of Mato Grosso do Sul, Campo Grande, Mato Grosso do Sul, Brazil.
Acta Trop. 2024 Dec;260:107441. doi: 10.1016/j.actatropica.2024.107441. Epub 2024 Oct 29.
Visceral leishmaniasis (VL) poses a serious health threat, particularly when untreated, necessitating accurate diagnosis. While the gold-standard method involves identifying amastigotes in bone marrow aspirate (BMA), this procedure is invasive and occasionally contraindicated. Additionally, when VL is associated with HIV infection the serologies accuracies could be affected. This study aims to evaluate and compare diagnostic methods for VL in patients with and without HIV coinfection. We enrolled prospectively 127 consecutive adult VL patients, 48 (37.8%) of whom had HIV coinfection, in Brazil's Midwestern region, where VL is endemic. Parasitological examination served as the reference standard for accuracy analysis, with index tests including immunofluorescent antibody test (IFAT), immunochromatographic test with rK39 protein (rK39-ICT), and blood polymerase chain reaction (PCR). Specificity assessment involved 430 healthy blood donors from the same endemic area. Ninety-two patients had parasitologically confirmed VL. Among HIV-uninfected patients, rK39-ICT exhibited sensitivity comparable to PCR (93.6%; 95% CI: 83.6-100 vs. 97.8%; 95% CI: 93.6-99.2, respectively) and superior to IFAT (71.1%; 95% CI: 57.9-84.3). However, in HIV-infected patients, rK39-ICT sensitivity was notably lower than PCR (40.0%; 95% CI: 22.5-57.5 vs. 97.4%; 95% CI: 92.5-98.9) and similar to IFAT (67.5%; 95% CI: 52.9-82.0). Combining two serological tests in parallel identified 82.1% of parasitologically confirmed VL cases, with a negative likelihood ratio significantly lower than either test alone. No test achieved a specificity of 90%, and there were no significant differences in specificity observed among the index tests. The positivity rate of parasitological examination in the 127 VL patients was higher in HIV-infected compared to HIV-uninfected patients, 91.3% (95% CI: 83.2-99.4) versus 67.6% (95% CI: 56.9-78.3), respectively. These findings underscore the necessity of accounting for HIV infection when choosing VL diagnostic methods. Although rK39-ICT provides reliable results in HIV-uninfected patients, BMA examination remains crucial for accurate diagnosis in individuals with HIV/AIDS. In cases where bone marrow aspiration is contraindicated, employing IFAT and rK39-ICT in parallel could be considered, as the occurrence of both positive results is uncommon in healthy individuals from endemic areas.
内脏利什曼病（VL）构成严重的健康威胁，尤其是在未经治疗的情况下，因此需要准确诊断。虽然金标准方法是在骨髓穿刺液（BMA）中识别无鞭毛体，但该操作具有侵入性，且偶尔存在禁忌。此外，当VL与HIV感染相关时，血清学检测的准确性可能会受到影响。本研究旨在评估和比较合并或未合并HIV感染的VL患者的诊断方法。我们前瞻性地招募了巴西中西部地区连续的127例成年VL患者，其中48例（37.8%）合并HIV感染，该地区VL为地方病。寄生虫学检查作为准确性分析的参考标准，指标检测包括免疫荧光抗体试验（IFAT）、rK39蛋白免疫层析试验（rK39-ICT）和血液聚合酶链反应（PCR）。特异性评估涉及来自同一地方病流行区的430名健康献血者。92例患者经寄生虫学确诊为VL。在未感染HIV的患者中，rK39-ICT的敏感性与PCR相当（分别为93.6%；95%CI：83.6 - 100与97.8%；95%CI：93.6 - 99.2），且优于IFAT（71.1%；95%CI：57.9 - 84.3）。然而，在感染HIV的患者中，rK39-ICT的敏感性显著低于PCR（40.0%；95%CI：22.5 - 57.5与97.4%；95%CI：92.5 - 98.9），与IFAT相似（67.5%；95%CI：52.9 - 82.0）。同时进行两项血清学检测可识别82.1%经寄生虫学确诊的VL病例，其阴性似然比显著低于单独使用任何一项检测。没有一项检测的特异性达到90%，且在指标检测中未观察到特异性的显著差异。127例VL患者中，感染HIV患者的寄生虫学检查阳性率高于未感染HIV的患者，分别为91.3%（95%CI：83.2 - 99.4）和67.6%（95%CI：56.9 - 78.3）。这些发现强调了在选择VL诊断方法时考虑HIV感染的必要性。虽然rK39-ICT在未感染HIV的患者中能提供可靠结果，但BMA检查对于HIV/AIDS患者的准确诊断仍然至关重要。在骨髓穿刺禁忌的情况下，可以考虑同时使用IFAT和rK39-ICT，因为在地方病流行区的健康个体中，两项检测结果均为阳性的情况并不常见。
