Last Updated: 14/05/2018

Clinical Performance of the Histidine Rich Protein 2 (HRP2) Highly Sensitive Rapid Diagnostic Test (HS-RDT) for Malaria Diagnosis in Pregnant Women in Papua New Guinea

Objectives

The overall goal of this project is to study the performance of the highly-sensitive RDT for the detection of P. falciparum infection during pregnancy, compared with conventional good quality RDTs, microscopy, and LAMP in peripheral blood samples with qPCR asthe reference standard.

Principal Institution

Burnet Institute, Australia
FIND, Switzerland

Partner Institutions

Papua New Guinea Institute of Medical Research (PNG IMR), Papua New Guinea

Rationale and Abstract

Outcome measures: (Individual level) Estimates of sensitivity, specificity, negative predictive value, positive predictive value, and diagnostic odds ratio of HRP2 HSRDT for the detection of P. falciparum during pregnancy, compared with conventional good quality RDTs, microscopy and LAMP in peripheral blood with qPCR as reference test.

Selection criteria: All women must meet all the following inclusion criteria in order to be eligible to participate in the study:

Pregnant women attending first antenatal care visit at selected health facilities
Resident in the study area for at least 1 year prior to enrolment
Age ≥ 16
Willing to freely participate with signed informed consent (or in the presence of an independent witness, in the case of illiterate participants)
Willing to provide finger-prick blood sample

ClinicalTrials.gov Identifier: NCT03462615

Study Design