Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533696
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
A Comparison of Microscopy and Enzyme Linked Immunosorbent Assay for Diagnosis of Giardia Lamblia in Children Sohag
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Comparison of Microscopy and Enzyme Linked Immunosorbent Assay for Diagnosis of Giardia Lamblia in Children Sohag
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study was done to evaluate the efficacy of Human anti Giardia lamblia antibody ELISA kitst in comparison to direct microscopy in the diagnosis of G lamblia in stool specimens from immunocompetent and immunocompromised children with diarrhea and other gastrointestinal symptoms
Detailed Description:
Giardia duode- nalis is an intestinal protozoan parasite with a worldwide distribu- tion in human and
animals Dixon BR2021
According to WHO reports in 2010 giardiasis is estimated to cause approximately 282 million cases of
diarrhea WHO2015
The prevalence of giardiasis is 2 to 5 in developed countries and 20 to 30 in developing countries in children Luis et al2017
The fecal-oral route is the main transmission mode of G duodenalis Drinking water food and
vegetables contaminated by G duodenalis cysts are the main sources of transmission Adam Rodney2021
The common clinical manifestations of giardiasis include greasy diarrhea steatorrhea nausea
vomiting abdominal bloating cramps malabsorption and weight loss Taghipour et al 2022
The detection and diagnosis of giardiasis present challenges for physicians especially in regions distant
from high-prevalence areas where a substantial number of asymptomatic patients further complicate
prevalence determination Symptoms which closely mimic those of other parasitic diseases can
confound clinicians potentially leading to the prescription of ineffective remedies Escobedo et al 2018
Several different diagnostic systems have been described for the diagnosis of giardiasis among them are
microscopic diagnosis molecular methods and immunoassays such as ELISA for the detection
of Giardia antigen or anti-Giardia antibodies and Direct Fluorescence Antibody DFA test which
detects antigens present on the cell wall of Giardia cysts Sadaka et al 2015
The early accurate diagnosis of giardiasis is important for the successful treatment and prevention of
diseases The routine laboratory diagnosis is performed for the detection of trophozoites or cysts by
microscopic examination of at least three stool samples collected independently Uehlinger et al2017
This diagnosis depends upon the times of sampling patient compliance application of concentration
methods and the expertise of the technologists Furthermore in recent years other methods such as
ELIZA and molecular techniques are used mainly for diagnostic or research purposes The sensitivity
and specificity of all diagnostic methods can be improved by including alternative diagnostic procedures
that are more rapid and reliable Kosack et al2017
The recently licensed commercially available enzyme-linked immunosorbent assay ELISA kits are
found to be rapid and effective methods to diagnose Giardia infection in patients with gastrointestinal
symptomatology by detecting G lamblia associated antigens in stool Jahan et al2014
animals Dixon BR2021
According to WHO reports in 2010 giardiasis is estimated to cause approximately 282 million cases of
diarrhea WHO2015
The prevalence of giardiasis is 2 to 5 in developed countries and 20 to 30 in developing countries in children Luis et al2017
The fecal-oral route is the main transmission mode of G duodenalis Drinking water food and
vegetables contaminated by G duodenalis cysts are the main sources of transmission Adam Rodney2021
The common clinical manifestations of giardiasis include greasy diarrhea steatorrhea nausea
vomiting abdominal bloating cramps malabsorption and weight loss Taghipour et al 2022
The detection and diagnosis of giardiasis present challenges for physicians especially in regions distant
from high-prevalence areas where a substantial number of asymptomatic patients further complicate
prevalence determination Symptoms which closely mimic those of other parasitic diseases can
confound clinicians potentially leading to the prescription of ineffective remedies Escobedo et al 2018
Several different diagnostic systems have been described for the diagnosis of giardiasis among them are
microscopic diagnosis molecular methods and immunoassays such as ELISA for the detection
of Giardia antigen or anti-Giardia antibodies and Direct Fluorescence Antibody DFA test which
detects antigens present on the cell wall of Giardia cysts Sadaka et al 2015
The early accurate diagnosis of giardiasis is important for the successful treatment and prevention of
diseases The routine laboratory diagnosis is performed for the detection of trophozoites or cysts by
microscopic examination of at least three stool samples collected independently Uehlinger et al2017
This diagnosis depends upon the times of sampling patient compliance application of concentration
methods and the expertise of the technologists Furthermore in recent years other methods such as
ELIZA and molecular techniques are used mainly for diagnostic or research purposes The sensitivity
and specificity of all diagnostic methods can be improved by including alternative diagnostic procedures
that are more rapid and reliable Kosack et al2017
The recently licensed commercially available enzyme-linked immunosorbent assay ELISA kits are
found to be rapid and effective methods to diagnose Giardia infection in patients with gastrointestinal
symptomatology by detecting G lamblia associated antigens in stool Jahan et al2014
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None