Last Updated

23 Nov 2018

Performance of a High-Sensitivity Rapid Diagnostic Test for Plasmodium falciparum Malaria in Asymptomatic Individuals from Uganda and Myanmar and Naïve Human Challenge Infections

Objectives

The overall goal of this project is to compare the performance of the highly-sensitive RDT with the current available SD Bioline Malaria Ag P.f RDT in blood specimens from asymptomatic individuals in Nagongera, Uganda, and in a Karen Village, Myanmar, representative of high- and low-transmission areas, respectively, as well as in pre-treatment specimens from study participants from four Plasmodium falciparum-induced blood-stage malaria (IBSM) studies. 

Principal Institution(s)

Principal Investigator
Rationale and Abstract

Although laboratory assays are more sensitive than microscopy and RDTs, they are also more expensive, require highly trained personnel, take longer to produce results, and are more difficult to deploy for large-scale field use. An Alere Malaria Ag P.f Ultra Sensitive RDT (hsRDT) was developed for field use and evaluated for detection of low-density infections. Compared with the current commercial HRP2-based SD BIOLINE Malaria Ag P.f. RDT (RDT), the hsRDT uses the same immunochromatographic cassette platform, has the same whole blood volume requirements (5 µL), and takes only 5 minutes longer to result, making this device a promising and highly sensitive field tool.

A quantitative reverse transcription PCR (qRT-PCR) and a highly sensitive enzyme-linked immunosorbent assay (ELISA) test for histidine-rich protein II (HRP2) were used as reference assays.

Inclusion criteria: no fever history in the previous 7 days, axillary temperature less than 37.5°C, absence of other clinical signs of malaria, and no malaria treatment within the previous 60 days.

Population sample size: n= 607 from 100 selected random households to recruit children 6 months to 11 years old (Uganda), n=493 from visited households to recruit children and adults as part of an ongoing study to assess mass drug administration for malaria elimination (Myanmar), n=93 whole blood specimens from 16 human volunteers.

Study Design
  • Household survey (Uganda, Myanmar)
  • Pf challenge human malaria infection study (Australia) 
  • Outcome measures:
    • (Individual level) Parasite densities; HRP2 concentration; Diagnostic accuracy (sensitivity, specificity, negative predictive value, positive predictive value)
  • Gold standard: qRT-PCR, ELISA
  • Comparators: qPCR, qRT-PCR, RDT, ELISA
  • Population selection criteria: No fever history in the previous 7 days, axillary temperature less than 37.5°C, absence of other clinical signs of malaria, and no malaria treatment within the previous 60 days.
  • Population sample size: 
    • n= 607 from 100 selected random households to recruit children 6 months to 11 years old (Uganda)
    • n=493 from visited households to recruit children and adults as part of an ongoing study to assess mass drug administration for malaria elimination (Myanmar)
    • n=93 whole blood specimens from 16 human volunteers
Thematic Categories

Date

2015 Jan - 2017 Dec

Funding Details

Funded under Diameter III (OPP1135840)
Project Site