Grupo de Investigación del Laboratorio de Salud Pública de Boyacá, Secretaria de Salud de Boyacá, Tunja, Colombia, Doctorado en Metodología de la Investigación Biomédica y Salud Pública, Universitat Autònoma de Barcelona, Barcelona, Spain.
Grupo de Investigación del Laboratorio de Salud Pública de Boyacá, Secretaria de Salud de Boyacá, Tunja, Colombia.
PLoS Negl Trop Dis. 2021 Jun 2;15(6):e0009483. doi: 10.1371/journal.pntd.0009483. eCollection 2021 Jun.
To evaluate diagnostic precision of two rapid diagnostic tests (RDT's) on patients with chronic Chagas disease.
Prospective study with the following inclusion criteria: subjects older than 3 years, signed informed consent. Exclusion criterion: subjects could not have previously received treatment for infection with T. cruzi. The study population were participants in a screening process undertaken in rural and urban zones of the department Boyacá, Colombia. Two RDT's were performed to all participants: the Chagas Detect Plus InBios (CDP) and the Chagas Stat-Pak (CSP) and as a reference standard the ELISA Chagas III GrupoBios and the Chagas ELISA IgG+IgM I Vircell tests were used. In the case of discordant results between the two ELISA tests, an indirect immunofluorescence was done.
Three hundred-five (305) subjects were included in the study (38 patients with leishmaniasis), of which 215 tested negative for T cruzi and 90 tested positive according to the reference standard. The sensitivity of the RDT's were 100% (CI 95% 95.9-100), and the specificity of the CDP was 99.1% (CI 95% 96.6-99.8) and for CSP was 100% (CI 95% 98.3-100). The agreement of CDP was 99.5% and for CSP was 100% with Kappa values of (k = 99.1; CI 95% 92.6-99.8%) and (k = 100; CI 95% 94.3-100), respectively. RDT's did not present cross-reactions with samples from patients who were positive for leishmaniasis.
The findings demonstrate excellent results from the RDT's in terms of validity, safety, and reproducibility. The results obtained provide evidence for the recommendation for using these tests in a Colombian epidemiological context principally in endemic areas in which laboratory installations necessary to perform conventional tests are not available, or they are scarce and to help in diagnosing chronic Chagas disease in order to provide access to treatment as soon as possible.
评估两种快速诊断检测（RDT）在慢性恰加斯病患者中的诊断精度。
前瞻性研究，纳入标准如下：年龄大于 3 岁，签署知情同意书。排除标准：患者不能有先前接受过感染克氏锥虫治疗。研究人群为哥伦比亚博亚卡省农村和城市地区筛查过程中的参与者。对所有参与者进行两种 RDT 检测：Chagas Detect Plus InBios（CDP）和 Chagas Stat-Pak（CSP），并将 ELISA Chagas III GrupoBios 和 Chagas ELISA IgG+IgM I Vircell 检测作为参考标准。如果两种 ELISA 检测结果不一致，则进行间接免疫荧光检测。
共纳入 305 名（38 名患有利什曼病）患者，其中 215 名 T cruzi 检测结果为阴性，90 名根据参考标准检测结果为阳性。RDT 的灵敏度均为 100%（95%CI 95.9-100），CDP 的特异性为 99.1%（95%CI 96.6-99.8），CSP 的特异性为 100%（95%CI 98.3-100）。CDP 的一致性为 99.5%，CSP 的一致性为 100%，kappa 值分别为（k = 99.1；95%CI 92.6-99.8%）和（k = 100；95%CI 94.3-100）。RDT 未与利什曼病阳性患者的样本发生交叉反应。
这些 RDT 的有效性、安全性和可重复性结果均表现出色。研究结果为在哥伦比亚流行病学背景下推荐使用这些检测提供了证据，特别是在没有必要进行常规检测的实验室设施的流行地区，或者这些设施稀缺的情况下，以及帮助诊断慢性恰加斯病，以便尽快获得治疗。
