Resource compilation: Responding to the threat of pfhrp2/3 deletions
In May 2021, the WHO Malaria Policy Advisory Group (MPAG) released a statement for urgent action in all endemic countries to address the threat of pfhrp2/3 gene deletions and most expeditiously in the Horn of Africa.
WHO has issued guidance on investigating suspected pfhrp2/3 deletions and is encouraging a harmonized approach to mapping and reporting of pfhrp2/3 deletions. This MESA compilation brings together a list of resources available:
WHO guidance
- False-negative RDT results and P. falciparum histidine-rich protein 2/3 gene deletions: Information note
- Response plan to pfhrp2 gene deletions
WHO has published Template protocols to support surveillance and research for pfhrp2/3 gene deletions. Two types of protocols are available:
- Surveillance-only: Surveillance template protocol for pfhrp2/pfhrp3 gene deletions [English PDF] / [French PDF] - NOTE that this document was modified on 19 January 2023. The modifications are listed in the following file: corrigenda (surv. only)
- Surveillance combined with biobanking: Master protocol for surveillance of pfhrp2/3 deletions and biobanking to support future research [English PDF] / [French PDF] - NOTE that this document was modified on 19 January 2023. The modifications are listed in the following file: corrigenda (surv. & biobanking)
* WHO can provide assistance in the molecular analyses through its reference laboratory network
(contact: malaria_rdt@who.int)
WHO tracking
- Pfhrp2/3 Dashboard – WHO questionnaire to track planned and ongoing surveillance of pfhrp2/3 deletions
- Malaria Threats Map – WHO mapping tool to track published reports of pfhrp2/3 deletions
- WHO Systematic Review – Prevalence of Plasmodium falciparum lacking histidine-rich proteins 2 and 3: a systematic review (Bull. WHO; 2020)
Malaria RDT products (including non-HRP2 based tests)
- Selecting and procuring malaria RDTs – WHO Global Malaria Programme procurement information
- Results of WHO product testing of malaria RDTs (Round 8) – Includes performance assessment against HRP2-negative parasites (see Table 9)
- List of Malaria RDTs according to the Global Fund Quality Assurance Policy – Products eligible for GF procurement after assessment by: (i) the WHO Prequalification (PQ) of Diagnostics Programme; or (ii) the Global Fund's Expert Review Panel for Diagnostics (ERPD) [March 2023]
- WHO List of Prequalified In Vitro Diagnostic products – IVDs that meet WHO prequalification requirements [February 2023]
- In Vitro Diagnostics Under Assessment (WHO Prequalification) – Progress of the active applications in the prequalification of IVDs assessment pipeline [April 2023; List of Malaria RDTs]
Additional references
REVIEWS
Laboratory & screening methodologies:
- Beshir KB et al. (2022) Malaria Journal – Screening strategies and laboratory assays to support Plasmodium falciparum histidine-rich protein deletion surveillance: where we are and what is needed
Systematic reviews & meta-analyses:
- Zeleke AJ et al. (2022) Malaria Journal
- Molina-de la Fuente I et al. (2021) Malaria Journal
- Nyataya J et al. (2020) MDPI
- Kojom LP et al. (2020) Malaria Journal
- Agaba BB et al. (2019) Malaria Journal
MEDIA
- WHO video: Malaria diagnosis - Addressing the issue of HRP2 gene deletions [with French or Spanish subtitles]
- MESA interview: Malaria parasites 'invisible' to rapid tests: A conversation with Selam Mihreteab (Eritrea)
- Malaria Minute podcast (JHSPH): Malaria parasites mutate again to evade RDTs, rapid diagnostic tests
- The Conversation (article): Some malaria parasites are evading detection tests, causing an urgent threat to public health
VIRTUAL EVENTS and CONFERENCES
- MESA Forum (2022): Responding to the threat of malaria parasites evading HRP2-RDTs [Forum materials]
- ASTMH-2020 Symposium (#167): Tracking the Threat of pfhrp2/3 Gene Deletions and Future Alternatives to HRP2-based Malaria Diagnosis [MESA Correspondents Report]
- ASTMH-2017 Symposium (#62): Malaria Rapid Diagnostic Testing: Understanding and Managing the Threat of PfHRP2/3-Negative Plasmodium falciparum [MESA Correspondents Report + Presentation Videos]
PROCEDURE for WHO COMPLAINTS
Any problems experienced by countries concerning RDT performance can be formally communicated to WHO:
- Reporting safety, quality, performance issues for medical devices including in vitro diagnostics (generic procedure for complaints related to in vitro diagnostics)
- Complaints Handling by WHO (concerning a prequalified in vitro diagnostic)
