Detection of Lipoarabinomannan in Urine, Evaluation of the STANDARDTM F TB LAM FIA and Its Impact on the Initial Diagnosis of TB
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Evaluate the diagnostic performance of a new test based on the detection of lipoarabinomannan (LAM) antigen in human urine using immunoassay
研究概览
简要总结
Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU).
详细描述
STANDARDTM F TB LAM Ag FIA is a fluorescent immunoassay which detects lipoarabinomannan in human urine sample. The test evaluated in this study may provide benefits for the development of non sputum-based, less invasive tuberculosis diagnostics that include easier to collect biological samples. The study can therefore be relevant for updating WHO guidelines for TB diagnosis. The results of the STANDARDTM F TB LAM Ag FIA will be interpreted according to the manufacturer´s instructions and will be compared to the results of the test performed to confirm the pulmonary TB, the extrapulmonary TB or the pulmonary NTM diagnosis (intention to treat assay). The test will be repeted at the end of the anti-TB therapy to evaluate if the test can be used as marker of treatment response. Healthy subjects without exposure or risk for TB factors will serve as a proxy for specificity; subjects with confirmed TB will serve as control group to estimate sensitivity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for PTB, PNTM and extraPTB:
- •Adult subjects with documented active pulmonary TB, pulmonary NTM or extrapulmonary TB
- •Subjects who have signed informed consent
- •Aged ≥18 years
- •Inclusion criteria for HC:
- •healthy donors who have signed informed consent
- •aged ≥ 18 years
- •no TB or NTM risk factors or exposure
排除标准
- •Exclusion criteria for PTB, PNTM and extraPTB:
- •Do not have active pulmonary TB, NTM or extrapulmonary TB
- •Do not sign the informed consent
- •Are aged < 18 years
- •Exclusion criteria for HC:
- •Have active pulmonary TB or NTM
- •Do not sign the informed consent
- •Are aged < 18 years
结局指标
主要结局
Evaluate the diagnostic performance of a new test based on the detection of lipoarabinomannan (LAM) antigen in human urine using immunoassay
时间窗: 12 months
STANDARDTM F TB LAM Ag FIA is a fluorescent immunoassay for the qualitative detection of specific antigen from mycobacterial lipoarabinomannan (LAM) in urine. The test should be used with the STANDARD F Analyzers manufactured by SD BIOSENSOR that are Europium (Eu) based fluorescent immunoassay system and have been designed for easy and reliable measuring of diverse parameters. The test result of a specimen is given either as Positive or Negative with a COI (cut off index) value. The test may provide benefits for the development of non sputum-based, less invasive tuberculosis diagnostics that include easier-collect biological samples. The results of the test will be compared to the results of the test performed to confirm the pulmonary TB, the extrapulmonary TB or the pulmonary NTM diagnosis Healthy subjects without exposure or risk for TB factors will serve as a proxy for specificity; subjects with confirmed TB will serve as control group to estimate sensitivity.
次要结局
- Exploratory Objectives Evaluate if the test can be used as marker of treatment response (only for PTB subjects)(6 months)
研究者
Daniela Maria Cirillo
head Emerging Bacterial Pathogens Unit
Ospedale San Raffaele