WHO Prequalification of In-vitro diagnostics program to include Syphilis Rapid Diagnostic Tests
Congenital Syphilis is the second leading cause of still births globally1. In 2014, the World Health Organisation (WHO) initiated the Global Guidance on Criteria and Processes for Validation: Elimination of mother-to-child transmission of HIV and Syphilis. The aim of this strategy was 95% coverage of syphilis screening during pregnancy and rapid treatment with penicillin of those women found to be positive 1.
Syphilis Rapid Diagnostic Tests (RDTs) are recommended in the WHO guidelines for syphilis screening and treatment of pregnant women. As a result, Syphilis RDTs will be assessed based on safety, quality and performance for inclusion on the WHO list of prequalified in-vitro diagnostic (IVDs) products. The WHO list of prequalified IVDs helps countries make evidence-based selections when purchasing IVDs deemed to be safe, effective and cost-efficient.
NRL is designated a WHO Collaborating Centre for Diagnostics and Laboratory Support for HIV and AIDS and Other Blood-borne Infections. On 20-21 August NRL Evaluations Team Leader Susie Braniff participated in discussions to review and ratify dossier requirements for the WHO prequalification of syphilis RDTs. The NRL Evaluations team will also work with the Institute of Tropical Medicine in Belgium, to source an appropriate syphilis sample panel to enable evaluation of this testing.
It is expected that prequalification assessment of syphilis RDTs will be announced at the end of 2018 and will commence in the first quarter of 2019.
Ref: 1. World Health Organisation 2018, accessed 29 August, <http://www.who.int/diagnostics_laboratory/pq-syphilis-rdts/en/>