Dysentery Amebic Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 2021 |
| Est. primary completion date | October 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Patients complaining of dysentery or diarrhea with any age & sex groups. Exclusion Criteria: - Patients taking amoebicidal drugs. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Faculty of medicine-Sohag University | Sohag |
| Lead Sponsor | Collaborator |
|---|---|
| Sohag University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. |