Target product profile for a dengue pre-vaccination screening test
PLOS Neglected Tropical Diseases·
- DOI
- 10.1371/journal.pntd.0009557
- PMID
- 34324505
- PMCID
- PMC8320982
- OpenAlex
- W3183889415
- Study type
- Journal article
- Publisher
- Public Library of Science (PLoS)
- Article type
- journal-article
- Integrity
- current
Why this research matters now
Pre-vaccination screening addresses a critical safety concern by identifying seropositive individuals who can safely receive Dengvaxia while protecting dengue-naive persons from vaccine-associated hospitalization risk. Country-level test selection will depend on local seroprevalence, performance metrics, risk tolerance, and cost-effectiveness.
Structured evidence summary
Research question
The work aimed to establish a target product profile for a rapid diagnostic test that could screen individuals for prior dengue infection before administering Dengvaxia vaccine, following evidence that seronegative recipients face increased risk of severe disease.
Study design
The profile was developed through face-to-face consultative meetings, follow-up regional consultations, and a technical working group that reviewed the diagnostic landscape and built consensus on reference testing standards.
Population and setting
The screening test is intended for use in dengue-endemic settings where vaccination is being considered, with performance requirements varying according to local seroprevalence and risk tolerance.
Main findings
The target product profile emphasizes high specificity and describes minimum and ideal characteristics for a point-of-care rapid diagnostic test that is affordable, sensitive, and specific. The group defined risk-benefit tradeoffs across different seroprevalence levels and proposed pathways to streamline regulatory approval and policy development.
Public-health relevance
Pre-vaccination screening addresses a critical safety concern by identifying seropositive individuals who can safely receive Dengvaxia while protecting dengue-naive persons from vaccine-associated hospitalization risk. Country-level test selection will depend on local seroprevalence, performance metrics, risk tolerance, and cost-effectiveness.
Important limitations
This summary relies on the supplied single-article abstract and metadata. Full interpretation of the target product profile, including detailed performance thresholds, cost-benefit modeling assumptions, and regulatory recommendations, requires review of the original paper.
GIDS interpretation
The article is indexed under Dengue, Diagnostics, Vaccination, and Health policy topics. It describes a tool development effort rather than reporting primary epidemiologic or clinical trial data.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 13 auditable classifier relationships to diseases, places, topics, and study design.