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

Malaria during pregnancy remains an important public health issue in endemic countries. Most cases of malaria in pregnant women are asymptomatic, and can contribute to adverse outcomes, such as maternal and neonatal anaemia as well as low birth weight. Infections that do not cause symptoms (sub-clinical infections) - particularly in low transmission settings -remain difficult to diagnose during pregnancy but can contribute to adverse outcomes e.g. growth restriction, premature birth, miscarriage and stillbirth.

The Bill & Melinda Gates Foundation (BMGF) has supported the development of an HRP2-based high sensitivity rapid diagnostic tests (HS-RDT) that has analytical sensitivity ten times better than current RDTs and a sensitivity near 80% when compared to the 'gold standard' of quantitative polymerase chain reaction (qPCR). In this regard, the new HS-RDT may be a promising diagnostic and screening test for subclinical malaria during pregnancy.

The overall aim is to compare the performance of novel high sensitivity rapid detection tests with conventional rapid diagnostic tests for Plasmodium falciparum malaria infection in pregnant women in Papua New Guinea

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Key information

Conditions

Plasmodium Falciparum Malaria Diagnoses Disease Disease Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Malaria Protozoan Infections Vector Borne Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Nonga General Hospital

Rabaul, East New Britain Province, Papua New Guinea

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion 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, if illiterate, provide a thumbprint in the presence of an independent witness)
Willing to provide finger-prick blood sample

Exclusion criteria

Women meeting any of the following exclusion criteria at screening will be excluded from study participation:

History of malaria or antimalarial drugs used in the last three months, as recalled or documented in health record
Presence of severe malaria as defined by WHO guidelines at the moment of recruitment.

Presence of symptoms and signs of other serious chronic disease such as severe anaemia, tuberculosis and/or central nervous system infections, as defined by WHO guidelines

Treatment and study plan

HS-RDT

Diagnostic Test

A single finger-prick blood sample will be collected and used to test participants with the HS-RDT. The results of the results of the test will not be used for treatment purposes nor used to inform patient care.

Other names: ultra sensitive RDT

Primary outcomes

Sensitivity, specificity, negative predictive value and positive predictive value

Time frame: 1 year

1.1 Estimates of sensitivity, specificity, negative predictive value, positive predictive value, and diagnostic odds ratio of HRP2 HS-RDT 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.

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Collaborators

Burnet Institute
Papua New Guinea Institute of Medical Research

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Mar 12, 2018
Registry last updated: Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed