Center for Technological Development in Health, National Institute of Science and Technology for Innovation in Neglected Population Diseases, Oswald Cruz Foundation, Rio de Janeiro 21040-361, RJ, Brazil.
Tropical Medicine Graduate Program (Stricto Sensu), Oswaldo Cruz Institute, Oswald Cruz Foundation, Rio de Janeiro 21040-361, RJ, Brazil.
Int J Mol Sci. 2024 Sep 11;25(18):9811. doi: 10.3390/ijms25189811.
We developed a protein to rapidly and accurately diagnose Chagas disease, a life-threatening illness identified by the WHO as a critical worldwide public health risk. Limitations in present day serological tests are complicating the current health situation and contributing to most infected persons being unaware of their condition and therefore untreated. To improve diagnostic testing, we developed an immunological mimic of the etiological agent, , by combining ten pathogen-specific epitopes within the beta-barrel protein structure of Thermal Green Protein. The resulting multi-epitope protein, DxCruziV3, displayed high specificity and sensitivity as the antibody capture reagent in an ELISA platform with an analytical sensitivity that exceeds WHO recommendations. Within an immunochromatographic platform, DxCruziV3 showed excellent performance for the point of application diagnosis in a region endemic for multiple diseases, the municipality of Barcelos in the state of Amazonas, Brazil. In total, 167 individuals were rapidly tested using whole blood from a finger stick. As recommended by the Brazilian Ministry of Health, venous blood samples were laboratory tested by conventional assays for comparison. Test results suggest utilizing DxCruziV3 in different assay platforms can confidently diagnose chronic infections by . Rapid and more accurate results will benefit everyone but will have the most noticeable impact in resource-limited rural areas where the disease is endemic.
我们开发了一种蛋白质，能够快速、准确地诊断恰加斯病，这种危及生命的疾病被世界卫生组织认定为全球重大公共卫生风险。目前血清学检测方法的局限性使当前的健康状况更加复杂，并导致大多数感染者不知道自己的病情，因此未得到治疗。为了改进诊断检测，我们通过将 Thermal Green Protein 的 β-桶蛋白结构中的十个病原体特异性表位组合，开发了一种病原体的免疫模拟物。由此产生的多表位蛋白 DxCruziV3 作为 ELISA 平台中的抗体捕获试剂，具有高特异性和灵敏度，其分析灵敏度超过世界卫生组织的建议。在免疫层析平台中，DxCruziV3 在巴西亚马逊州 Barcelos 市这一多种疾病流行地区的现场应用诊断中表现出极佳的性能。总共有 167 人使用手指采血进行了快速测试。按照巴西卫生部的建议，对静脉血样本进行了实验室常规检测，以作比较。检测结果表明，利用 DxCruziV3 在不同的检测平台上，可以可靠地诊断慢性感染。快速、更准确的结果将使每个人受益，但在疾病流行的资源有限的农村地区，将产生最显著的影响。
