Campos-Neto Antonio, Abeijon Claudia
DetectoGen Inc., Westborough, MA 01581, USA.
Cummings School of Veterinary Medicine, Tufts University, North Grafton, MA 01536, USA.
Microorganisms. 2020 Oct 28;8(11):1676. doi: 10.3390/microorganisms8111676.
This review describes and appraises a novel protein-based antigen detection test for visceral leishmaniasis (VL). The test detects in patient's urine six proteins from and , the etiological agents of VL. The gold standard test for VL is microscopic observation of the parasites in aspirates from spleen, liver, or bone marrow (and lymph node for dogs). Culture of the parasites or detection of their DNA in these aspirates are also commonly used. Serological tests are available but they cannot distinguish patients with active VL from either healthy subjects exposed to the parasites or from subjects who had a successful VL treatment. An antigen detection test based on the agglutination of anti-leishmania carbohydrates antibody coated latex beads has been described. However, the results obtained with this carbohydrate-based test have been conflicting. Using mass spectrometry, we discovered six / proteins excreted in the urine of VL patients and used them as markers for the development of a robust mAb-based antigen (protein) detection test. The test is assembled in a multiplexed format to simultaneously detect all six markers. Its initial clinical validation showed a sensitivity of 93% and specificity of 100% for VL diagnosis.
本综述描述并评估了一种用于内脏利什曼病（VL）的新型基于蛋白质的抗原检测试验。该试验可在患者尿液中检测到来自VL病原体杜氏利什曼原虫和婴儿利什曼原虫的六种蛋白质。VL的金标准检测方法是对脾脏、肝脏或骨髓（犬类为淋巴结）穿刺物中的寄生虫进行显微镜观察。在这些穿刺物中培养寄生虫或检测其DNA也较为常用。血清学检测方法也有，但无法区分活动性VL患者与接触过寄生虫的健康受试者或已成功治疗VL的受试者。已有一种基于抗利什曼原虫碳水化合物抗体包被乳胶珠凝集反应的抗原检测试验。然而，这种基于碳水化合物的检测试验所得结果存在矛盾。我们利用质谱法发现了VL患者尿液中排泄的六种利什曼原虫/婴儿利什曼原虫蛋白质，并将其用作开发一种强大的基于单克隆抗体的抗原（蛋白质）检测试验的标志物。该试验以多重检测形式组装，可同时检测所有六种标志物。其初步临床验证显示，对VL诊断的敏感性为93%，特异性为100%。
