Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572644
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Performance of an Ultrasensible Malaria Rapid Diagnostic Test Among Pregnant Women in Burkina Faso
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of a Highly Sensitive Rapid Diagnostic Test for Detecting Falciparum Malaria Infection in Pregnancy in Burkina Faso
Status:
COMPLETED
Status Verified Date:
2024-08
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:
HS-RDT-MiP
Brief Summary:
The goal of this observational study is to learn about the diagnostic performance of the highly sensitive rapid diagnostic test HS-RDT compared to an ultrasensitive qPCR for detection of falciparum malaria in pregnant women attending antenal care ANC in Burkina Faso The main question it aims to answer is
What are the sensitivity and specificity of the HS-RDT compared to ultrasensitive quantitative polymerase chain reaction qPCR considered as gold standard for dection of falciparum malaria in pregnant women attending ANC in Burkina Faso Participants will be included during their ANC visits and screened for malaria using the HS_RDT the conventional RDT Co_RDT microscopy and qPCR
What are the sensitivity and specificity of the HS-RDT compared to ultrasensitive quantitative polymerase chain reaction qPCR considered as gold standard for dection of falciparum malaria in pregnant women attending ANC in Burkina Faso Participants will be included during their ANC visits and screened for malaria using the HS_RDT the conventional RDT Co_RDT microscopy and qPCR
Detailed Description:
A cross-sectional study including 288 pregnant women was conducted at the Centre médical urbain CMU of Lafiabougou located in the periurban area of Bobo-Dioulasso the second largest city of Burkina Faso Pregnant women attending their ANC visits at the CMU of Lafiabougou were recruited and enrolled into the study if eligible criteria were fulfilled
At enrolment an individual structured questionnaire was administered to the selected pregnant women and their sociodemographic data age educational level and profession and history of illness was collected In addition obstetric history parity gestational age number of ANC visits uptake of IPTp-SP and clinical information body temperature weight height and arm circumference were recorded Thereafter a venous blood sample 5 mL was collected to screen for malaria infection based on HS-RDT Co_RDT and thick and thin blood smears dried blood spots DBS for molecular studies and haemoglobin concentration measurement The remaining blood sample was stored for future studies
After enrolment only pregnant women eligible for their first IPTp-SP dose uptake was followed up for 30 days to assess the impact of IPTp-SP on both falciparum parasitaemia and falciparum resistant strains At the end of follow up a venous blood sample 5 mL was collected for thick and thin blood smears DBS and haemoglobin concentration measurement The remaining blood sample was stored for future studies
All biological samples was collected and stored at ambient temperature before being transported to the Laboratory of Parasitology of Centre MURAZ and processed
The index tests included HS_RDT NxTek Eliminate Malaria Pf product code 05FK140 batch No 05LDG008B AlereAbbott Republic of Korea Co_RDT AdvDxTM Malaria Pf product code 004ADFEF025KI-2 batch No ADF770222 Advy Chemical India and light microscopy
The ultrasensitive qPCR assay targeting the multicopy conserved var gene acidic terminal sequence varATS Hofmann et al 2015 was used as gold standard
At enrolment an individual structured questionnaire was administered to the selected pregnant women and their sociodemographic data age educational level and profession and history of illness was collected In addition obstetric history parity gestational age number of ANC visits uptake of IPTp-SP and clinical information body temperature weight height and arm circumference were recorded Thereafter a venous blood sample 5 mL was collected to screen for malaria infection based on HS-RDT Co_RDT and thick and thin blood smears dried blood spots DBS for molecular studies and haemoglobin concentration measurement The remaining blood sample was stored for future studies
After enrolment only pregnant women eligible for their first IPTp-SP dose uptake was followed up for 30 days to assess the impact of IPTp-SP on both falciparum parasitaemia and falciparum resistant strains At the end of follow up a venous blood sample 5 mL was collected for thick and thin blood smears DBS and haemoglobin concentration measurement The remaining blood sample was stored for future studies
All biological samples was collected and stored at ambient temperature before being transported to the Laboratory of Parasitology of Centre MURAZ and processed
The index tests included HS_RDT NxTek Eliminate Malaria Pf product code 05FK140 batch No 05LDG008B AlereAbbott Republic of Korea Co_RDT AdvDxTM Malaria Pf product code 004ADFEF025KI-2 batch No ADF770222 Advy Chemical India and light microscopy
The ultrasensitive qPCR assay targeting the multicopy conserved var gene acidic terminal sequence varATS Hofmann et al 2015 was used as gold standard
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