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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04759937
Enrollment
100
Registered
2021-02-18
Start date
2021-03-20
Completion date
2021-12-31
Last updated
2021-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysentery Amebic

Keywords

dysentery, diarrhea, Entamoeba, histolytica, dispar

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.

Interventions

None listed

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Patients taking amoebicidal drugs.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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.

Countries

Egypt

Contacts

Primary Contactkhoulood Zakaria Hashem
khoulood.zakaria@med.sohag.edu.eg01127936972

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026