Accuracy and efficacy of pre-dengue vaccination screening for previous dengue infection with a new dengue rapid diagnostic test: a retrospective analysis of phase 3 efficacy trials

Performance Evaluation of a Dengue IgG Rapid Diagnostic Test Designed to Determine Dengue Serostatus as Part of Prevaccination Screening

“…Furthermore, samples were restricted to a subset of five out of the 10 countries participating in the phase III CYD-TDV vaccine trials due to country-level restrictions on future research use of serum samples. However, while this study did not use a truly random selection of samples, these results are comparable to a study of the sensitivity and specificity of the OnSite dengue IgG RDT when samples from subjects ≥6 years of age of the entire immunogenicity subset of CYD14 and CYD15 are used; sensitivity (91.8%; 95% CI = 90.7 to 92.9) and specificity (96.1%; 95% CI = 94.5 to 97.3) ( 18 ). Additionally, the study population does not fully reflect the exposure history of individuals currently living in dengue endemic areas, as the samples used in this study were drawn in 2011 to 2012, prior to the large Zika epidemic in the Americas (2015 to 2017) and before the ongoing SARS-CoV-2 pandemic (starting end 2019).…”

“…The OnSite dengue IgG Rapid Test displays just over 88% sensitivity in identifying dengue monotypic immune individuals, and in a head-to-head comparison was comparable to two of the more sensitive, commercially available dengue IgG ELISAs ( 18 ). Achieving high sensitivity in detecting true dengue-seropositive individuals is key to reducing the population risk of severe dengue with CYD-TDV vaccination in low-moderate to high dengue endemic settings.…”

Dengue: A review of laboratory diagnostics in the vaccine age

“…It is reported as 95 % sensitive (88 % in prior monotypic infection and 98 % in multitypic infection) and 98 % specific [194]. There was no significant difference in serotype sensitivity for prior monotypic infection [197]. There was minimal cross-reactivity with other flaviviruses.…”

Is new dengue vaccine efficacy data a relief or cause for concern?

“…A dengue vaccine available only to dengue immune recipients may have clinical value but lack the necessary practical attributes to support meaningful uptake. A 'test and vaccinate' strategy, although feasible, could be very difficult to operationalize across the multitude of dengue endemic areas [90][91][92][93][94] . A good vaccine not used for vaccination delivers no benefit.…”