Target product profile for a dengue pre-vaccination screening test
| Autor: | Eng Eong Ooi, Rosanna W. Peeling, Piero Olliaro, Annelise Wilder-Smith, Duane J. Gubler, Xavier de Lamballerie, Noah Fongwen, Edsel Maurice T Salvana |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
RNA viruses
Viral Diseases Epidemiology Physiology RC955-962 Pathology and Laboratory Medicine Antibodies Viral Biochemistry Dengue fever Dengue Fever Dengue 0302 clinical medicine Medical Conditions Arctic medicine. Tropical medicine Immune Physiology Medicine and Health Sciences Medicine Mass Screening Public and Occupational Health 030212 general & internal medicine Enzyme-Linked Immunoassays 610 Medicine & health Immune System Proteins Vaccination Absolute risk reduction Reference Standards Vaccination and Immunization Test (assessment) Viewpoints Infectious Diseases Medical Microbiology Point-of-Care Testing Viral Pathogens Viruses Public aspects of medicine RA1-1270 Pathogens 360 Social problems & social services Neglected Tropical Diseases medicine.medical_specialty 030231 tropical medicine Immunology Dengue Vaccines Research and Analysis Methods Vaccines Attenuated Microbiology Sensitivity and Specificity Antibodies 03 medical and health sciences Environmental health Vaccine Development Seroprevalence Humans Serologic Tests Immunoassays Microbial Pathogens Point of care Flaviviruses business.industry Public health Public Health Environmental and Occupational Health Organisms Biology and Life Sciences Proteins Dengue Virus medicine.disease Tropical Diseases Medical Risk Factors Immunologic Techniques Preventive Medicine Serostatus business |
| Zdroj: | PLoS Neglected Tropical Diseases Fongwen, Noah; Wilder-Smith, Annelise; Gubler, Duane J; Ooi, Eng Eong; T Salvana, Edsel Maurice; de Lamballerie, Xavier; Olliaro, Piero L; Peeling, Rosanna W (2021). Target product profile for a dengue pre-vaccination screening test. PLoS neglected tropical diseases, 15(7), e0009557. Public Library of Science 10.1371/journal.pntd.0009557 PLoS Neglected Tropical Diseases, Vol 15, Iss 7, p e0009557 (2021) |
| ISSN: | 1935-2735 1935-2727 |
| DOI: | 10.1371/journal.pntd.0009557 |
| Popis: | With increasing geographic spread, frequency, and magnitude of outbreaks, dengue continues to pose a major public health threat worldwide. Dengvaxia, a dengue live-attenuated tetravalent vaccine, was licensed in 2015, but post hoc analyses of long-term data showed serostatus-dependent vaccine performance with an excess risk of hospitalized and severe dengue in seronegative vaccine recipients. The World Health Organization (WHO) recommended that only persons with evidence of past dengue infection should receive the vaccine. A test for pre-vaccination screening for dengue serostatus is needed. To develop the target product profile (TPP) for a dengue pre-vaccination screening test, face-to-face consultative meetings were organized with follow-up regional consultations. A technical working group was formed to develop consensus on a reference test against which candidate pre-vaccination screening tests could be compared. The group also reviewed current diagnostic landscape and the need to accelerate the evaluation, regulatory approval, and policy development of tests that can identify seropositive individuals and maximize public health impact of vaccination while avoiding the risk of hospitalization in dengue-naive individuals. Pre-vaccination screening strategies will benefit from rapid diagnostic tests (RDTs) that are affordable, sensitive, and specific and can be used at the point of care (POC). The TPP described the minimum and ideal characteristics of a dengue pre-vaccination screening RDT with an emphasis on high specificity. The group also made suggestions for accelerating access to these RDTs through streamlining regulatory approval and policy development. Risk and benefit based on what can be achieved with RDTs meeting minimal and optimal characteristics in the TPP across a range of seroprevalences were defined. The final choice of RDTs in each country will depend on the performance of the RDT, dengue seroprevalence in the target population, tolerance of risk, and cost-effectiveness. Author summary This paper describes the consensus on the minimum and ideal performance and operational characteristics of rapid tests that would be used for dengue pre-vaccination screening. This profile will incentivize industry to develop better pre-vaccination screening tests. The choice of which test to use depends on the seroprevalence of the population targeted for vaccination and the optimal balance between benefit and risks. The group also made suggestions for accelerating access to these pre-vaccination screening tests through streamlining regulatory approval and policy development. |
| Databáze: | OpenAIRE |
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