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.
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。