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

• Conditions: Dysentery Amebic

• Registration Number: NCT04759937
• Lead Sponsor: Sohag University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-14
• Study First Submitted QC: 2021-02-14
• Study First Posted: 2021-02-18
• Study Start: 2021-03-20
• Status Verified: 2021-10
• Primary Completion: 2021-10
• Last Update Submitted: 2021-10-09
• Last Update Posted: 2021-10-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Patients taking amoebicidal drugs.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of medicine-Sohag University; 🇪🇬 Sohag, Egypt