IMMUNODIAGNOSTIC TESTS FOR THE RAPID DIAGNOSIS OF TB

快速诊断结核病的免疫诊断测试

• 批准号: 7605762
• 负责人: Jacqueline Michele Achkar
• 金额: $ 0.27万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605762
• 关键词: Acquired Immunodeficiency Syndrome; Advanced Development; Antibodies; Antitubercular Agents; Biological Assay; Cause of Death; Class; Clinical; Computer Retrieval of Information on Scientific Projects Database; Detection; Diagnosis; Disease; Enrollment; Funding; Goals; Gold; Grant; Hospitals; Immunological Diagnosis; Institution; Medical center; Mycobacterium tuberculosis; New York City; Observational Study; Patients; Population; Proteins; Public Health; Pulmonary Tuberculosis; Recombinant Proteins; Research; Research Personnel; Resources; Sensitivity and Specificity; Serum; Source; Specificity; Standards of Weights and Measures; T-Lymphocyte; Testing; Tuberculosis; United States; United States National Institutes of Health; base; improved; prospective; rapid diagnosis; research clinical testing; tuberculosis treatment

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Tuberculosis (TB) is a global leading public health problem and the leading cause of death in people with AIDS. There is an urgent need for early and accurate diagnosis of pulmonary TB (PTB) to achieve the goal of elimination of TB in the United States, improve TB control worldwide, and identify and treat active TB before development of advanced disease. Currently, no rapid tests with high sensitivity and specificity are available for all classes of TB. The investigators propose to examine the accuracy and clinical value of antibody detection to two immunodominant proteins of M. tb for the rapid diagnosis of PTB. The central hypothesis is that a serodiagnostic test, in the form of two protein-based ELISAs combined, is accurate and clinically useful. Alone and in combination with a rapid T-cell-based assay, it can serve as an adjunct to current conventional rapid tests for PTB. The specific aims of this project are as follows: 1) to assess sensitivity, specificity and clinical value of the ELISAs; 2) to determine serum antibody titers to the two recombinant proteins pre, at and post antituberculosis treatment of TB patients; and 3) to test if other available recombinant proteins of M. tb will enhance the sensitivity of the ELISAs without compromising specificity. This will be a prospective, observational study in a United States population. Consecutive patients undergoing clinical evaluation for PTB will be enrolled from two large hospitals in New York City (Bellevue Hospital Center and the Manhattan VA Medical Center). Results of the ELISAs and other tests will be compared to the gold standard of culture of histological or clinically proven PTB.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 结核病是全球主要的公共卫生问题，也是艾滋病患者死亡的主要原因。迫切需要对肺结核进行早期准确的诊断，以实现美国消灭结核病的目标，改善世界范围内的结核病控制，并在晚期疾病发展之前识别和治疗活动性结核病。目前，还没有对所有类型的结核病都具有高灵敏度和高特异性的快速检测。研究人员建议检测结核分枝杆菌两种免疫优势蛋白抗体检测的准确性和临床应用价值。中心假设是，以两种基于蛋白质的ELISA相结合的形式进行血清诊断试验是准确的，并且在临床上是有用的。单独使用，并与基于T细胞的快速检测相结合，它可以作为目前常规结核病快速检测的辅助手段。该项目的具体目标如下：1)评估ELISA的敏感性、特异性和临床价值；2)测定结核病患者在抗结核治疗前、治疗时和治疗后的血清抗体效价；以及3)测试结核分枝杆菌的其他重组蛋白是否会在不影响特异性的情况下提高ELISA的敏感性。这将是一项在美国人群中进行的前瞻性、观察性研究。连续接受肺结核临床评估的患者将从纽约市的两家大型医院(贝尔维尤医院中心和曼哈顿退伍军人医疗中心)登记。ELISA和其他测试的结果将与组织学或临床证实的肺结核培养的黄金标准进行比较。