Last Updated

24 Jun 2022

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

Objectives

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 (uRDT/hsRDT) for the detection of malaria during pregnancy in low transmission settings from Colombia.

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 the reference standard.

Rationale and Abstract

Clinical Trials identifier: NCT03172221

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.

Population selection criteria: Consecutive pregnant women self-presenting at the selected health care facilities and meeting the eligibility criteria will be invited to participate in the study.

Sampling method: Non-Probability Sample

Additional activities:

Performance of a highly sensitive rapid diagnostic test (HS-RDT) for detecting malaria in peripheral and placental blood samples from pregnant women in Colombia

A total of 766 pregnant women self-presenting at local hospitals for ANC visit, at delivery or seeking medical care for suspected malaria were consecutively recruited. Women, aged ≥ 15 years old, at any gestational age, and living in peri-urban municipality areas or rural areas with malaria transmission were considered eligible for the study. Each participant was enrolled only once in one of the two study groups (ANC or delivery). Population sample size: 737

Methodology: Observational cross-sectional trial (retrospective study)

Outcome measures: (Individual level) Diagnostic accuracy (Sensitivity, specificity, negative predictive value, positive predictive value, diagnostic odds ratio (DOR)

Timeframe: From September to December 2017

Study Design

Cross-sectional and multicentre clinical trial

Thematic Categories

Date

2017 May - 2018 Jan

Funding Details

Part of the Bill & Melinda Gates Foundation Grant OPP1169555
Project Site