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

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

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 as reference standard.

PI Institution(s)

Funding source(s)

Partner(s)

Abstract

Methodology: Observational cross-sectional trial (prospective study)

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

Clinical Performance of the Histidine Rich Protein 2 (HRP2) Highly Sensitive Rapid Diagnostic Test (HS-RDT)...

Key facts

  • Dates
    Jun 2018 to Dec 2018
    Country
    • Papua New Guinea

MESA tags

  • Methodology
    Product development & clinical research
    Theme(s)
    Asymptomatic reservoir, Tools for elimination