Thanks to intensified interventions to prevent, diagnose and treat malaria, incidence of the disease decreased by an estimated 41% globally between 2000 and 2015, and by 21% between 2010 and 2015. Global malaria targets for 2030 include the reduction of malaria incidence and mortality by at least 90% compared to 2015 levels. Reaching these ambitious targets will require new, more sensitive rapid diagnostic tests to detect asymptomatic malaria infections.
P. falciparum standardized culture panels
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 manufacturers to develop new high sensitivity malaria rapid diagnostic tests.
HRP2 is the antigen used in most malaria rapid diagnostic tests to detect P. falciparum. By providing a range of standard HRP2 concentrations, including some that are very low, the panel can be used to evaluate the diagnostic sensitivity of improved tests that are in development.
The project was sponsored by the Bill & Melinda Gates Foundation.
Reference recombinant HRP2 proteins
The histidine-rich protein 2 (HRP2) is a protein secreted at relatively high levels by Plasmodium falciparum parasites residing in red blood cells of infected individuals. As a result, HRP2 represents a good marker of malaria infection, and the vast majority of P. falciparum rapid diagnostic tests (RDTs) rely on the detection of this specific antigen. However, it is highly polymorphic and cases of deletion have been reported in some areas.
Despite its major role in currently available diagnostics for P. falciparum malaria, no common HRP2 standard reagents exist to support the development of improved RDTs.
FIND, in partnership with Microcoat Biotechnologie (Germany) and others, is producing standardized HRP2 proteins equivalent to native proteins found in naturally occurring parasites. It includes major polymorphic types and consists of recombinant proteins expressed in heterologous systems.
These proteins represent a valuable asset for evaluating the performance of marketed RDTs in quality control programs, and unparalleled tools to calibrate HRP2-detecting assays and measure the performance of new assays in development against a common set of standards, facilitating the prioritization of the most promising.
Malaria specimen bank
FIND manages a large collection of malaria specimens from symptomatic as well as asymptomatic infections that are available by application to commercial and academic researchers working towards the development of malaria diagnostics suitable for low- and middle-income settings.
The malaria specimen bank contains frozen EDTA whole blood samples from consenting symptomatic (aged 10 years or older) or asymptomatic (aged 18 years or older) patients, including:
- P. falciparum – 0.2 mL aliquots (symptomatic and asymptomatic specimens available
- P. falciparum pfhrp2 wild-type – 0.2 mL aliquots (only asymptomatic specimens available)
- P. falciparum pfhrp2 deleted – 0.2 mL aliquots (only asymptomatic specimens available)
- P. vivax – 0.2 mL aliquots (symptomatic and asymptomatic specimens available)
- P. ovale – 0.2 mL aliquots (only asymptomatic specimens available)
- P. malariae – 0.2 mL aliquots (only asymptomatic specimens available)
- P. spp. negative from matching collection areas – 0.2 mL aliquots
The aim in maintaining the specimen bank is to assist in the development or evaluation of emerging or existing diagnostic tools that are considered promising for improving the diagnosis of malaria in low- and middle-income countries.
A Specimen Bank Review Committee (SBRC), composed of five qualified members involved in diagnostics development and malaria control, will review and approve or reject applications from requesting parties. Requests which address the following criteria will be given the highest priority:
- Relevance to public health (feasibility and impact on patients and disease control programmes)
- Applicability of the technology in high-burden countries
- Low cost of final product
- Previous data or scientific evidence supporting the request
Numbers of samples requested should be based on real needs to achieve the objectives described in the Material Request Form.
All requests for samples are made by submitting a Material Request Form and a Material Transfer Agreement (part of the material request form). Applicants are to cover handling fees and shipping costs, unless otherwise agreed with FIND. Handling fee is US$50 per aliquot. Shipment costs will depend on the destination address. Estimates can be provided in advance upon request.