In an effort to guide research and development efforts and assist donors, technical agencies and ministries of health to select products that best respond to public health needs, the WHO Global Malaria Programme, with input from a Target Product Profile Development Group made up of clinicians, public health experts and laboratory scientists, has developed 2 prioritized target product profiles (TPPs) for assays that measure G6PD activity. Each TPP outlines "acceptable" and "desirable" characteristics. These tools are expected to support the expansion of safe and effective radical cure of P. vivax (and P. ovale) in malaria-endemic countries and to serve needs in other target populations.
The TPPs submitted for public consultation describe 2 types of G6PD tests:
The first is a G6PD triage or screening test (TPP#1) to be performed at the point of care when there is an acute need for G6PD activity determination.
The second is a one-time quantitative assay for G6PD activity (TPP#2) principally intended to establish baseline G6PD activity (phenotype) + /- genotype (of common variants) and haemoglobin concentration, which has the capacity for individual specific data recall. Although anticipated to be technically more complex than TPP#1 and dependent on some basic laboratory infrastructure, it will be more accessible than current reference standard testing and performance requirements are highly comparable allowing for one-time testing.
→ Read the draft TPPs for consultation
Comments can be submitted through the following links:
- TPP #1 – Point of care screening or triage test for G6PD activity: https://extranet.who.int/dataformv3/index.php/145588?lang=en
- TPP#2 – One-time quantitative assay for G6PD activity: https://extranet.who.int/dataformv3/index.php/597349?lang=en
This call is now closed.