The World Health Organization has recommended prevaccination screening for prior
dengue infection as the preferred approach prior to vaccination with the
dengue vaccine CYD-TDV. These screening tests need to be highly specific and sensitive, and deliverable at the point-of-care. We evaluate here the sensitivity and specificity of the newly developed OnSite
Dengue IgG rapid diagnostic test (RDT). A retrospective double-blind study of the sensitivity and specificity of the OnSite
Dengue IgG RDT was performed using a sample panel consisting of archived serum specimens collected during CYD-TDV clinical trials in Latin American and Asia, with the reference serostatus for each sample determined by an algorithm using measured
dengue PRNT90, PRNT50, and NS1
IgG ELISA. An additional panel of
dengue seronegative samples positive for other flaviviruses and
infections was used to assess cross-reactivity. Samples were included from 579 participants; 346 in the specificity panel and 233 in the sensitivity panel. The OnSite
dengue IgG RDT exhibited a specificity of 98.0% (95% CI = 95.9 to 99.2) and sensitivity of 95.3% (95% CI = 91.7 to 97.6). The sensitivity for samples exhibiting a multitypic immune profile (PRNT90-positive to >1
dengue serotype) was 98.8% while for monotypic immune samples (PRNT90-positive to a single
dengue serotype) it was 88.1%. The OnSite
dengue IgG RDT showed minimal to no cross-reactivity to related flaviviruses. These findings support the use of the OnSite
dengue IgG RDT to determine
dengue serostatus in CYD-TDV prevaccination screening. IMPORTANCE
Dengue remains a significant public health issue, with over 5.2 million cases reported to the World Health Organization (WHO) in 2019. The
tetravalent dengue vaccine (CYD-TDV) is currently licensed for use in those aged ≥9 years; however, vaccinees with no previous exposure to
dengue experience an increased risk of hospitalized and
severe dengue upon subsequent heterotypic
infection. Consequently, WHO recommends screening for prior
dengue infection before vaccination. Screening tests for previous
infection need to be highly specific and sensitive, and deliverable at the point-of-care. High sensitivity ensures that the largest number of individuals with previous
infection can be identified and vaccinated, while high specificity prevents the inadvertent vaccination of those without previous
infection. This study of the OnSite
Dengue IgG Rapid Test, which was explicitly developed to meet this need, found that it had both high specificity (98.0% [95% CI = 95.9 to 99.2]) and sensitivity (95.3% [95% CI = 91.7 to 97.6]).