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临床试验/NCT05579821
NCT05579821已完成不适用

Evaluation of DPP® Typhoid Assay (Chembio Diagnostic System, Inc) for the Diagnosis of Typhoid From Well Characterized Serum Sample.

Foundation for Innovative New Diagnostics, Switzerland1 个研究点 分布在 1 个国家目标入组 387 人开始时间: 2022年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
387
试验地点
1
主要终点
Point estimates of sensitivity and specificity with 95% confidence interval of DPP Typhoid assay using blood culture as reference standard

研究概览

简要总结

Fever management is a major problem in Low and Middle Income Countries (LMICs) where access to good quality diagnostic test is often unavailable. Fever due to typhoid is similar to other undifferentiated febrile illnesses and typhoid can be mistaken with other vector borne febrile illnesses such as scrub typhus. Currently available diagnostic tests, blood and bone marrow culture, and RDTs have several limitations including a low sensitivity and specificity . Recently, several antigens of Salmonella Typhi useful for serodiagnosis of typhoid has been identified. Salmonella Typhi lipopolysaccharide (LPS) and hemolysin E (HlyE) have been identified as top candidate antigens by several studies to differentiate acute typhoid patients from healthy individuals. DPP® Typhoid Assay is a multiplex rapid test that detects IgA antibodies to LPS and HlyE antigen. It is considered to have high sensitivity and specificity and its results were found to be highly correlated with ELISA results. However, very few studies have been conducted to evaluate this test and limited information about the accuracy of this test is present. Hence, this study will evaluate the sensitivity and specificity of this test in archived serum sample of well characterized blood culture positives and negatives in support of new innovation on typhoid diagnostics.

详细描述

Typhoid is an acute febrile illness caused by Salmonella enterica serovar Typhi (S. Typhi). Annually, an estimated 11-21 million people become infected with typhoid fever and 128000-161000 people die from the disease . It is commonly transmitted through consumption of contaminated food or water. Low and middle-income countries and areas with poor access to safe water, food and sanitation are at higher risk of infection.

Blood and bone marrow culture is considered as the mainstay for laboratory confirmation of typhoid. However, it is expensive, requires specific laboratory equipment and technical expertise and takes longer time to generate results. Several RDTs and Widal test are available which do not require specialized laboratory and well-trained staff but lack sensitivity and specificity. Several studies have been done for identification of promising antigens that can be used to develop an accurate serodiagnostic assay. S. Typhi lipopolysaccharide (LPS) and hemolysin E (HlyE) have been identified as top candidate antigens by several studies to differentiate acute typhoid patients from healthy individuals. HlyE is a pore-forming toxin that affects bacterial growth within human macrophages and contributes to the cytotoxicity and invasion of epithelial cells.

Dual Path Platform (DPP) Typhoid Assay of Chembio is a point-of-care (POC) immunochromatographic technology which has the capability of measuring IgA response in blood, plasma and serum to both LPS and HlyE. A previous study done on this POC showed promising sensitivity and specificity to diagnose typhoid.Thus, the current study aims to assess the sensitivity and specificity of DPP ® Typhoid Assay using blood culture as the reference point.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
2 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria identical to the prior prospective study in AKU (Protocol ref number: FE006)
  • Serum stored frozen at AKU as a part of afore mentioned study and cold-chain maintained.

排除标准

  • Samples whose reference standard data (Blood culture report) are not available in FIND's OpenClinica database.

结局指标

主要结局

Point estimates of sensitivity and specificity with 95% confidence interval of DPP Typhoid assay using blood culture as reference standard

时间窗: October 2022

次要结局

  • Estimates of operational characteristics of DPP Typhoid Assay, based on quantitative assessment including invalid rates(Nov 2022)

研究者

发起方
Foundation for Innovative New Diagnostics, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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