Diagnostic Accuracy of the DPP Fever Panel II Asia and the DPP Micro Reader
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Point estimates of sensitivity and specificity, with 95% confidence intervals, for the detection of B. pseudomallei by the DPP assay in comparison to a reference standard.
研究概览
简要总结
Burkholderia pseudomallei is responsible for melioidosis, a disease that can present a range of signs and symptoms and can be treated by a specific drug regimen. Diagnosis of melioidosis is made by isolation of the bacteria from body fluids or tissues such as blood, skin or sputum. Although this is considered the gold standard, bacterial isolation has low diagnostic sensitivity, requires specific infrastructures (biosafety level 3 laboratories) and skilled staff that are not always available in LMICs. This may lead to inappropriate patient management and care.
Chembio, in partnership with FIND, has developed a multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect antigens from common causes of febrile illnesses, included Burkholderia. FIND will conduct a laboratory study in Menzies Health School of Research to estimate the diagnostic accuracy of the DPP II Assay using retrospective samples that are positive for B. pseudomallei. Results will help in estimating the diagnostic accuracy of the assay for this pathogen.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Samples that can be included in the trial must have been collected exclusively during the "Assessment of a New Rapid Diagnostic Test for Melioidosis" study (HREC 04/09) conducted by the Menzies School of Health Research. They must be well-characterized with confirmation of presence or absence of B. pseudomallei by bacterial culture.
排除标准
- •Samples with volume <120 µL
- •Samples collected during projects other than the HREC 04/09 project
结局指标
主要结局
Point estimates of sensitivity and specificity, with 95% confidence intervals, for the detection of B. pseudomallei by the DPP assay in comparison to a reference standard.
时间窗: 2 months
次要结局
未报告次要终点
