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

S

Sohag University

Status

Unknown

Conditions

Dysentery Amebic

Study type

Observational

Funder types

Other

Identifiers

NCT04759937
Soh-Med-21-02-16

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Patients taking amoebicidal drugs.

Trial contacts and locations

1

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Central trial contact

khoulood Zakaria Hashem

Data sourced from clinicaltrials.gov

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