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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dysentery Amebic

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Khoulood Zakaria Hashem; Phone Number: +20 01127936972; Email: khoulood.zakaria@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt, 093
    • Recruiting
    • Faculty of medicine-Sohag university
    • Contact: Khoulood Zakaria Hashem; Phone Number: +20 01127936972; Email: khoulood.zakaria@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

samples will be collected from outpatients complaining of dysentery or diarrhea with any age & sex groups from different locations (cities and village).

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients taking amoebicidal drugs.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the efficacy of immunochromatographic Copro-antigen assay for diagnosis of Entamoeba histolytica/ dispar.	comparing the sensitivity and specifity with conventional microscopy for diagnosis of Entamoeba histolytica/ dispar infection.	16 weeks following the startpoint of the study.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
detect the prevelance of Entamoeba histolytica/ dispar in Sohag.	By examining stool samples from 100 patients, the number of cases with Entamoena histolytica/dispar infection is recorded.	16 weeks following the startpoint of the study.

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 14, 2021
• First Submitted That Met QC Criteria: February 14, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 9, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: diarrhea; dysentery; Entamoeba; histolytica; dispar
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Dysentery
• Other Study ID Numbers: Soh-Med-21-02-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No