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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03462615
Recruitment Status : Not yet recruiting
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Burnet Institute
Papua New Guinea Institute of Medical Research
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

Brief Summary:

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

Condition or disease Intervention/treatment
Plasmodium Falciparum Malaria Pregnancy Malaria Diagnoses Disease Diagnostic Test: HS-RDT

Study Type : Observational
Estimated Enrollment : 930 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women in Papua New Guinea
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Malaria

Intervention Details:
  • Diagnostic Test: HS-RDT
    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 Name: ultra sensitive RDT

Primary Outcome Measures :
  1. Diagnostic accuracy [ 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.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
The study will test samples from pregnant women aged 16 and older, self-presenting at health centres for antenatal care in this malaria-endemic setting

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

Responsible Party: Foundation for Innovative New Diagnostics, Switzerland Identifier: NCT03462615     History of Changes
Other Study ID Numbers: 7815-2/2
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Foundation for Innovative New Diagnostics, Switzerland:
rapid diagnostic test

Additional relevant MeSH terms:
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases