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临床试验/NCT04759937
NCT04759937Unknown不适用

Immunochromatography Versus Microscopy for Diagnosis of Entamoeba Histolytica/Dispar Infection in Sohag.

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
evaluate the efficacy of immunochromatographic Copro-antigen assay for diagnosis of Entamoeba histolytica/ dispar.

研究概览

简要总结

Amoebiasis, an infection by the protozoan parasite Entamoeba histolytica is globally considered as the third leading parasitic cause of human mortality besides malaria and schistosomiasis. It is estimated that E. histolytica may infect half a billion people annually. Moreover, it was estimated that 100,000 patients per year died due to the clinical complications of the disease. Laboratory diagnosis of E. histolytica/dispar is usually achieved by microscopic detection of trophozoites or cysts in stool samples. Microscopy is time consuming and requires an experienced observer to identify the organism. Furthermore, it must be performed on three stool samples to increase sensitivity leading to decreased patient compliance and delay in the final diagnosis. Therefore, a few the commercially available copro-antigen assay have been developed for E. histolytica/dispar diagnosis including the enzyme immunoassay and non-enzymatic immunochromatographic (ICT) assays that do not depend on microscopy skills and increase laboratory efficiency by reducing time and cost.

The aim of the study is:

  1. to evaluate the efficacy of commercially available rapid immunochromatographic Copro-antigen assay (RIDA® QUICK Entamoeba) in comparison with conventional microscopic examination for the diagnosis of E. histolytica /dispar infection.
  2. to estimate the prevalence of E. histolytica /dispar infection in outpatients in Sohag.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients complaining of dysentery or diarrhea with any age & sex groups.

排除标准

  • Patients taking amoebicidal drugs.

结局指标

主要结局

evaluate the efficacy of immunochromatographic Copro-antigen assay for diagnosis of Entamoeba histolytica/ dispar.

时间窗: 16 weeks following the startpoint of the study.

comparing the sensitivity and specifity with conventional microscopy for diagnosis of Entamoeba histolytica/ dispar infection.

次要结局

  • detect the prevelance of Entamoeba histolytica/ dispar in Sohag.(16 weeks following the startpoint of the study.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khoulood Zakaria Hashem

Demonstrator at medical parasitology department, Faculty of medicine

Sohag University

研究点 (1)

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