Dengue pre-vaccination screening test evaluation for the use of dengue vaccine in an endemic area

Abstract

Background The dengue vaccine (Dengvaxia) is only recommended for individuals with prior dengue infection (PDI). This study aimed to perform a serosurvey to inform decision-making for vaccine introduction and identify appropriate target populations. We also evaluated the performance of the serological tests using plaque reduction neutralization test (PRNT) as a reference test in identifying PDI to determine suitability for pre-vaccination screening. Methods We enrolled 115 healthy individuals between 10 and 22 years of age living in the Ratchaburi province of Thailand. The serum samples were tested by PRNT to measure the prevalence and concentration of serotype-specific neutralizing antibodies. The performance of the IgG rapid diagnostic test (RDT, SD Bioline, Korea) and IgG enzyme-linked immunosorbent assay (ELISA, EUROIMMUN, Germany) in identifying PDI were evaluated by using PRNT as a reference method. Results Ninety-four (81.7%) individuals neutralized one or more dengue serotypes at a titer threshold greater than or equal to 10. Multitypic profiles were observed in 70.4% of the samples which increased to 91.9% in subjects aged 19–22. Among monotypic samples, the highest proportion was reactive against DENV-1 followed by DENV-2, DENV-3, and DENV-4. The highest anti-dengue antibody titers were recorded against DENV-1 and increased with age to a geometric mean NT50 titer (GMT) of 188.6 in the 19–22 age group. While both RDT and ELISA exhibited 100% specificity, RDT demonstrated low sensitivity (35%) with ELISA displaying much greater sensitivity (87%). Conclusions Almost 80% of adolescents and youth in Ratchaburi province had already been exposed to one or more of the dengue virus serotypes. The dengue IgG RDT displayed low sensitivity and is likely not be suitable for dengue pre-vaccination screening. These results support the use of IgG ELISA test for dengue vaccination in endemic areas.

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

“…8,17 Several RDTs have been suggested as potentially useful tools for pre-vaccination screening; 18 however, evaluations of commercially available RDTs to date have highlighted a need for the development of improved tests, in particular those with higher sensitivity, with evaluations of sensitivity of these tests ranging between 35% and 71%. [10][11][12][13][14]19 In our study, in the indicated age group for CYD-TDV (≥9 years), the new point-of-care OnSite IgG RDT showed high specificity (97%) and high sensitivity (92%); similar results were observed in the age group of participants aged 6 years or older. Therefore, the OnSite IgG RDT might be useful as a point-of-care pre-vaccination screening tool in dengue-endemic areas.…”

“…10 Other studies have also shown the limitations in sensitivity of currently available RDTs. 11,12 A new dengue IgG-specific RDT, the OnSite Dengue IgG RDT (Onsite IgG RDT; CTK Biotech, Poway, CA, USA), specifically designed for pre-vaccination screening has been developed. In this study, we aimed to assess the efficacy of CYD-TDV in participants of the phase 3 CYD14 and CYD15 studies who were determined to be seropositive to dengue by use of the OnSite IgG RDT and to assess assay performance.…”

A scoping literature review of global dengue age-stratified seroprevalence data: estimating dengue force of infection in endemic countries

“… 83 2012–2015 A 0.136 (0.127, 0.146) in-house Thailand Ratchaburi province 10–22 3 115 IgG ELISA Limothai U et al. 84 Aug 2019–Aug 2020 A 0.094 (0.074, 0.118) Bioline, Korea Venezuela Cana de Azucar 05–30 5 2002 Hemagglutination inhibition (HI) Velasco-Salas et al. 85 Aug 2010–Jan 2011 B 0.059 (0.015, 0.181) in-house Vietnam Nha Trang City, Nih Hoa district and Dien Khanh district (in Khanh Hoa province) 03–60 6 1479 indirect IgG ELISA Mai et al.…”

A handheld luminometer with sub-attomole limit of detection for distributed applications in global health

“…Additionally, the cost reduction alone as compared to commercial PMT-based devices may also increase accessibility in centralized locations such as pharmacies, where antibody levels might be recorded during a patient visit to inform on the need for vaccination. For example, in the case of dengue virus, it is particularly relevant to perform pre-vaccination serologic screening [40], suggesting the need for rapid, on-site quantitative patient testing. To increase reproducibility and promote dissemination, we provide a user guide, bill of materials, 3D CAD models, and fully-detailed build guide with instructions.…”