Performance of an Ultrasensible Malaria Rapid Diagnostic Test Among Pregnant Women in Burkina Faso (HS-RDT-MiP)

Evaluation of a Highly Sensitive Rapid Diagnostic Test for Detecting Falciparum Malaria Infection in Pregnancy in Burkina Faso

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.

Study Overview

• Status: Completed
• Conditions: Malaria,Falciparum

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, Alere/Abbott, Republic of Korea), Co_RDT (AdvDxTM Malaria Pf, product code 004ADFEF025KI-2, batch No. ADF77/0222, 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 Type: Observational
• Enrollment (Actual): 288

Contacts and Locations

Study Locations

• Burkina Faso
  • Houet
    • Bobo-Dioulasso, Houet, Burkina Faso, 390
      • Centre Médical Urbain de Lafiabougou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Pregnant women attending their ANC visits at the Centre Médical Urbain de Lafiabougou

Description

Inclusion Criteria:

• Living in Bobo-Dioulasso for at least 6 months before the beginning of the study ;
• Provision of informed consent.

Exclusion Criteria:

• Past history of malaria or antimalarial drugs within the last 3 months ;
• Having tested positive for malaria by microscopy or RDT in any previous ANC visit ;
• Symptoms and signs of severe malaria as defined by WHO.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of HS_RDT	It is defined as the proportion of positives that are correctly identified when compared with the gold standard (qPCR).	At baseline
Specificity of HS_RDT	It is defined as proportion of negatives that are correctly identified when compared with the gold standard (qPCR).	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive value	Probability that P. falciparum infection is present when HS_RDT, Co_RDT, and microscopy are positive	At baseline
Negative predictive value	Probability that P. falciparum infection is not present when HS_RDT, Co_RDT, and microscopy are negative	At baseline
The prevalence of Pfhrp2 and Pfhrp3 genes deletions among the study participants	Proportion of pregnant women with malaria parasites carrying Pfhrp2/Pfhrp3 deletions	At baseline
Impact of intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine (IPTp- SP) on falciparum parasitaemia	Proportion of pregnant women with falciparum parasitaemia 30 days after uptake of IPTp-SP	30 days after uptake of IPTp-SP

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of anaemia	Proportion of pregnant women with haemoglobin concentration <11 g/dL	At baseline
Prevalence of Pfdhfr & Pfhdps mutations	Proportion of pregnant women with Pfdhfr (N51I, C59R, S108N, I164L) and Pfdhps (A437G, K540E) mutations	At baseline

Collaborators and Investigators

• Sponsor: Centre MURAZ/Institut National de Santé Publique
• Collaborators: University of Ghana
• Investigators: Principal Investigator: Mamoudou Cissé, MD, PhD, Centre MURAZ/Institut National de Santé Publique

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy; Malaria; Performance; Burkina Faso; Ultrasensible rapid diagnostic test
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Mosquito-Borne Diseases; Malaria; Malaria, Falciparum
• Other Study ID Numbers: INSP_CM_09_2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No