Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759937
Status:
UNKNOWN
Last Update Posted:
2021-10-12
First Post:
2021-02-14
Brief Title:
Immunochromatography Versus Microscopy for Diagnosis of Entamoeba HistolyticaDispar Infection
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Immunochromatography Versus Microscopy for Diagnosis of Entamoeba HistolyticaDispar Infection in Sohag
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 100000 patients per year died due to the clinical complications of the disease Laboratory diagnosis of E histolyticadispar 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 histolyticadispar 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None