PDF(Pubmed)
Abstract：
BACKGROUND: The large reservoir of tuberculosis (TB) infections is one of the main reasons for the persistent incidence of TB. Accurate diagnostic tests are crucial to correctly identify and treat people with TB infection, which is vital to eliminate TB globally. The rdESAT-6 and rCFP-10 (Cy-Tb) injection (\'Cy-Tb\'), a TB-specific antigen skin test and STANDARD F TB-Feron FIA (\'Standard F TB\') measuring interferon-gamma by fluorescence immunoassay assay are two novel tools for the diagnosis of TB infection which offer advantages compared with current tests in low-resource settings and reduced costs to both health systems and TB-affected people. The proposed study aims to evaluate the diagnostic accuracy of these two new tests for TB infection diagnosis.
METHODS: This cross-sectional study aims to assess the diagnostic accuracy for TB infection of the Cy-Tb skin test and Standard F TB assay (investigational tests) compared with the QuantiFERON-TB Gold Plus (QFT-Plus) assay as the immunological reference standard. Three different cohorts of study participants will be recruited at the Vietnam National Lung Hospital: adults with bacteriologically confirmed pulmonary TB (n=100), household contacts of people with TB (n=200) and people without TB infection (n=50). All consenting participants will undergo simultaneous testing with Cy-Tb, Standard F TB and QFT-Plus. The primary endpoint is the diagnostic accuracy of the Cy-Tb skin test and Standard F TB assay, expressed as sensitivity and specificity against the reference standard.
BACKGROUND: Ethical approval was granted by the Vietnam National Lung Hospital Institutional Review Board (65/23/CN-HDDD-BVPTU) and the Swedish Ethical Review Authority (Dnr 2023-04271-01). Study results will be disseminated to the scientific community and policymakers through scientific publications.
BACKGROUND: NCT06221735.
METHODS: This cross-sectional study aims to assess the diagnostic accuracy for TB infection of the Cy-Tb skin test and Standard F TB assay (investigational tests) compared with the QuantiFERON-TB Gold Plus (QFT-Plus) assay as the immunological reference standard. Three different cohorts of study participants will be recruited at the Vietnam National Lung Hospital: adults with bacteriologically confirmed pulmonary TB (n=100), household contacts of people with TB (n=200) and people without TB infection (n=50). All consenting participants will undergo simultaneous testing with Cy-Tb, Standard F TB and QFT-Plus. The primary endpoint is the diagnostic accuracy of the Cy-Tb skin test and Standard F TB assay, expressed as sensitivity and specificity against the reference standard.
BACKGROUND: Ethical approval was granted by the Vietnam National Lung Hospital Institutional Review Board (65/23/CN-HDDD-BVPTU) and the Swedish Ethical Review Authority (Dnr 2023-04271-01). Study results will be disseminated to the scientific community and policymakers through scientific publications.
BACKGROUND: NCT06221735.
摘要：
背景：大量的结核病（TB）感染是结核病持续发病率的主要原因之一。准确的诊断测试对于正确识别和治疗结核病感染者至关重要，这对全球消除结核病至关重要。rdESAT-6和rCFP-10(Cy-Tb)注入(\'Cy-Tb\'),TB特异性抗原皮肤试验和标准FTB-FeronFIA（“标准FTB”）通过荧光免疫测定法测量干扰素-γ是诊断TB感染的两种新颖工具，与当前在低资源环境中的测试相比，具有优势，并降低了卫生系统和受TB影响人群的成本。拟议的研究旨在评估这两种新的结核病感染诊断测试的诊断准确性。
方法：本横断面研究旨在评估Cy-Tb皮肤试验和标准FTB试验（研究性试验）与QuantiFERON-TBGoldPlus（QFT-Plus）试验作为免疫学参考标准对TB感染的诊断准确性。将在越南国立肺部医院招募三个不同的研究参与者：患有细菌学证实的肺结核的成年人（n=100），结核病患者（n=200）和未感染结核病的人（n=50）的家庭接触者。所有同意的参与者将同时接受Cy-Tb测试，标准FTB和QFT-Plus。主要终点是Cy-Tb皮肤试验和标准FTB测定的诊断准确性，表示为对参考标准的敏感性和特异性。
背景：经越南国家肺部医院机构审查委员会（65/23/CN-HDDD-BVPTU）和瑞典伦理审查机构（Dnr2023-04271-01）批准。研究结果将通过科学出版物传播给科学界和决策者。
背景：NCT06221735。
方法：本横断面研究旨在评估Cy-Tb皮肤试验和标准FTB试验（研究性试验）与QuantiFERON-TBGoldPlus（QFT-Plus）试验作为免疫学参考标准对TB感染的诊断准确性。将在越南国立肺部医院招募三个不同的研究参与者：患有细菌学证实的肺结核的成年人（n=100），结核病患者（n=200）和未感染结核病的人（n=50）的家庭接触者。所有同意的参与者将同时接受Cy-Tb测试，标准FTB和QFT-Plus。主要终点是Cy-Tb皮肤试验和标准FTB测定的诊断准确性，表示为对参考标准的敏感性和特异性。
背景：经越南国家肺部医院机构审查委员会（65/23/CN-HDDD-BVPTU）和瑞典伦理审查机构（Dnr2023-04271-01）批准。研究结果将通过科学出版物传播给科学界和决策者。
背景：NCT06221735。
