Utility of Tongue Swab in Diagnosis of Pulmonary Tuberculosis In Children Using Nucleic Acid Amplification test.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of cases who are found to be positive on Tongue swab testing using Rapid cell Lysis System True lyse tm and NAAT True NAT MTB ultima among presumptive cases of pulmonary TB.
研究概览
简要总结
This is an observational diagnostic study evaluating the utility of tongue swabs in diagnosing pulmonary tuberculosis (PTB) in children using nucleic acid amplification tests (NAAT) such as Truenat. The study involves collecting tongue swab samples along with routine clinical samples (like gastric aspirates) from children with presumptive PTB. The results of NAAT performed on tongue swabs will be compared with standard diagnostic methods to assess sensitivity, and specificity.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Persistent fever without a known cause and Unremitting cough more than 2 weeks Weight loss of 5 percentage or no weight gain in the past 3 months despite adequate nutrition or failure of nutritional rehabilitation in baby with SAM With or without contact with patient with pulmonary TB in past 2 years.
排除标准
- •Children who received Antitubercular Therapy For more than 72 hours .
- •Children who can expectorate.
结局指标
主要结局
Proportion of cases who are found to be positive on Tongue swab testing using Rapid cell Lysis System True lyse tm and NAAT True NAT MTB ultima among presumptive cases of pulmonary TB.
时间窗: within 24 hours of sample processing
次要结局
- Sensitivity & specificity of GA CBNAAT & GA Truenat Using MGIT as gold standard .
研究者
Ashish Kumar Yadav
Department of Paediatrics Maulana Azad Medical College and Associated Lok Nayak Hospital