The WHO 5-year Strategic Plan (2019 – 2023) for WHO Regulatory Support Activities for Health Products outlines the maintenance and expansion of the prequalification service to help promote healthier populations as one of the strategic priorities. To that end, a consultation was organized to gather input from key stakeholders in order to determine the types of in vitro diagnostics for which prequalification is most needed and for which it will have the greatest benefit. The input received during the consultation was compiled and assessed by independent consultants. SAGE-IVD also provided recommendations. The final list of new IVDs accepted for prequalification assessment was determined in collaboration with WHO programmes.
In vitro diagnostics for the analytes/diseases listed below were identified by stakeholders as priority for addition to the Prequalification of in vitro diagnostics pipeline:
- Haemoglobin (point of care)
- Glucose meters and test strips
- Tuberculosis
- Yellow Fever
- Dengue Fever
- Gonorrhoea
- Chlamydia
- Measles
- Rubella
- Leishmaniasis
- Schistosomiasis
- Mycoplasma genitalium
- Onchocerciasis.
The WHO Prequalification Team will develop the Prequalification technical specifications and performance evaluations protocols and will identify dossier assessors and prequalification evaluating laboratories who will support prequalification assessments. It is expected that prequalification assessments will commence by the below timelines:
- 2020: Haemoglobin (point of care) and glucose meters and test strips
- 2021: Tuberculosis, yellow fever, dengue fever, gonorrhoea and chlamydia
- 2022: Measles, rubella, leishmaniasis and schistosomiasis
- 2023: Mycoplasma genitalium and onchocerciasis
The types of technologies for each infection/disease area listed above will be defined in consultation with WHO programmes and will be aligned with WHO testing guidelines.
IVDs for analytes/diseases currently eligible for prequalification assessment which include HIV-1 and HIV-2, HCV, HBsAg, malaria parasites, HPV, G6PD enzyme, toxigenic Vibrio cholerae and Treponema pallidum (Syphilis) and Hepatitis B nucleic acids, will remain within the programme scope and the types of technologies regularly reviewed with WHO programmes and partner organizations. In addition, quality control materials intended to be used in combination with IVDs within the programme scope will become eligible for prequalification assessment.