Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women (HSRDT MiP)

Foundation for Innovative New Diagnostics (FIND)

Status: Completed

Conditions: Pregnancy Malaria; Plasmodium Falciparum; Diagnoses Disease

Treatments: Diagnostic Test: HS-RDT

Study type: Observational

Funder types: Other

Identifiers

NCT03172221

7815-2/1

Details and patient eligibility

About

This is a cross-sectional and multicentre clinical trial to study the performance of the Histidine Rich Protein 2 (HRP2) highly sensitive rapid diagnostic test (HS-RDT) for the detection of malaria during pregnancy in low transmission settings from Colombia and Indonesia. The new HS-RDT will be compared with conventional good quality RDTs, microscopy, and NAATs [loop-mediated isothermal amplification (LAMP), nested PCR (nPCR)], in peripheral blood samples with quantitative reverse transcription PCR (qRT-PCR) as reference standard.

Full description

The activities proposed will be performed in the context of health centres receiving pregnant women for antenatal care visit. Finger-prick blood (300 µL) will be collected and used to test for malaria with the HS-RDT, as well as with conventional good quality RDTs, microscopy and local NAATs (LAMP and nPCR). Dried blood spots will also be collected for qRT-PCR testing. Patient information (demographics, obstetric history, malaria prevention measures, etc.) as well as laboratory results will be recorded and entered into a dedicated database.

Enrollment: 880 patients

Sex: Female

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with confirmed pregnancy and registered to the antenatal care programme in the local health centre
• Resident for at least 1 year in the study site
• Age ≥ 15
• Accepting to participate with willingness to give informed consent (pregnant adolescents younger than 18 y/o (age < 18) will be considered only if they are accompanied by parent or carer if it is requested by local Institutional Review Boards)
• Willingness to provide finger-prick blood sample at enrolment

Exclusion criteria

• Past history of malaria and/or antimalarial drugs in the last three months
• Positive for malaria by microscopy and conventional RDT testing in any previous study screening visit
• Presence of severe malaria as defined by WHO guidelines at the moment of recruitment
• Presence of symptoms and signs of other severe disease and central nervous system infections, as defined by WHO guidelines.