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临床试验/CTRI/2025/12/099334
CTRI/2025/12/099334尚未招募不适用

Molecular Diagnostic Accuracy and Novel Detection of Dengue Virus Using an NS2 Gene–Based Reverse Transcription Loop-Mediated Isothermal Amplification Assay

RUBINA MARY1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1

研究概览

简要总结

This study aims to evaluate the diagnostic accuracy of a novel NS2 gene based reverse transcription loop mediated isothermal amplification assay for detection of dengue virus. Clinically suspected dengue patients aged 0 to 65 years will be included and clinical samples will be tested using the DEN LAMP assay and compared with conventional RT PCR as the reference standard. The study will assess sensitivity specificity predictive values time to detection analytical performance operational feasibility cost per test and agreement between the two methods to determine the usefulness of DEN LAMP as a rapid and feasible diagnostic tool for dengue infection.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
0.00 Year(s) 至 65.00 Day(s)(—)
性别
All

入选标准

  • Clinically suspected dengue patients of both genders aged 0 to 65 years, as identified and referred by clinicians for laboratory investigation.
  • Written informed consent will be obtained from participants aged above 18 years.
  • For participants aged less than 18 years, written informed consent from parents or legally authorized guardians will be obtained, with assent from the child wherever applicable.

排除标准

  • Unsuspected Dengue patients and participants who could not provide informed consent will be excluded from the study.

研究者

发起方
RUBINA MARY
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Rubina Mary

Saveetha Medical College and Hospital

研究点 (1)

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