Platform to support development of improved rapid tests for malaria diagnosis

Platform to support development of improved rapid tests for malaria diagnosis

Objectives

To support the collection, characterization and access to well-characterized parasite specimens that are needed to support the development of new highly-sensitive Rapid Diagnostic Tests (uRDTs).

PI Institution(s)

Funding source(s)

Partner(s)

Abstract

In collaboration with a wide network of partners, FIND is establishing and maintaining a large repository of frozen whole blood specimens from asymptomatic individuals infected with Plasmodium falciparum parasites, as well as specimens from uninfected individuals collected in the same areas.

Also, additional reference material is already being made available. This includes whole blood samples spiked with low densities of cultured P. falciparum parasites—a unique resource for researchers and test developers. Microcoat Biotechnologie GmbH and FIND have worked in cooperation to develop three histidine-rich proteins (HRP2, types A, B and C), expressed as recombinant proteins in a heterologous system. These proteins are commercially available as stabilized and standardized reference materials for researchers, diagnostics developers and users of malaria rapid diagnostic tests. Press release here.

The proteins can be used for evaluating the performance of malaria rapid diagnostic tests in quality control programmes and for the calibration of HRP2 detection assays.

In addition, FIND and partners are producing standardized histidine-rich protein 2 (HRP2) recombinant proteins. HRP2 is secreted by P. falciparum parasites and is, therefore, a good marker of malaria infection.

The goal of these efforts is to make a common source of standardized specimens and HRP2 recombinant proteins available to malaria researchers and test developers. The reference materials can be used to assess the performance of prototype high-sensitivity tests and to calibrate currently available HRP2-detecting tests. ZeptoMetrix Corporation and FIND have produced the first commercially available malaria Plasmodium falciparum culture panels with standard concentrations of histidine rich protein 2 (HRP2). The ZeptoMetrix malaria P. falciparum culture panels, which are available in a range of concentrations from six different malaria strains, are intended for use by researchers and test developers to evaluate the performance of malaria rapid diagnostic tests. Press release here.

High-sensitivity infection detection test

Bill & Melinda Gates Foundation, How we work

Key facts

  • Dates
    Nov 2014 to Oct 2017
    Funding amount
    $4,123,546
    Funding information
    BMGF Grant OPP1116774

MESA tags

  • Methodology
    Product development & clinical research
    Theme(s)
    Asymptomatic reservoir