Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women

Foundation for Innovative New Diagnostics, Switzerland880 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

880

Conditions

Plasmodium Falciparum Pregnancy Malaria Diagnoses Disease

Interventions

Eligibility

Sex: FEMALEMin age: 15 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Diagnostic accuracy

Sensitivity, specificity, negative predictive value, positive predictive value, diagnostic odds ratio (DOR) and the area under the receiver operating characteristic curve (AUROC) of HRP2 HS-RDT for the detection of P. falciparum during pregnancy, compared with conventional good quality RDTs, microscopy and NAATs (LAMP, nPCR,), in peripheral blood with qRT-PCR as reference standard.

Time frame: 1 year