This invention relates to a novel diagnostic platform that is fast, affordable, specific and sensitive to the detection of dengue and chikungunya in a single-tube reaction. It is a multiplex molecular platform that allows simultaneous detection of the two viruses. In addition, the serotype(s) of dengue responsible for the infection can be diagnosed.
This diagnostic assay is fluorescence-based and confers an edge over probe-based real-time PCR as it eliminates the requirement to develop and optimise probes for detecting the viral templates while maintaining the degree of specificity and sensitivity to the viral genome RNAs. The platform can also be developed to include the detection of other mosquito-borne human alphaviruses and flaviviruses for more comprehensive point-of-care testing.
Molecular assay with fluorescence readout. The intensity of fluorescence correlates to the amount of genetic material present and amplified.
Proprietary primer sets distinguishing the different virus spp. and serotypes are available.
Assay conditions for specific and simultaneous amplication of the viruses are optimized to diagnose the virus spp. and serotypes.
Early detection and differentiation of dengue and chikungunya infections in countries endemic for both viral diseases are serious public health challenges. Dengue and chikungunya present very similar early symptoms that can be difficult to differentiate without performing a diagnostic analysis but it is important to do so as the delayed clinical management of dengue can lead to adverse outcomes. Dengue and chikungunya are conventionally diagnosed by serological methods (blood testing for antibodies). However, serological tests are generally only sensitive at least a week into an infection after sufficient antibodies have accumulated.
Advances in molecular techniques and rapid detection technology have produced diagnostic test kits for dengue and chikungunya but they are generally available separately. Having the means for the specific and simultaneous detection and differentiation of the dengue and chikungunya viruses would be ideal for clinical point-of-care. Such technology can compete in the global infectious disease in-vitro diagnostics market, which was valued at US$19 billion in 2018 and is expected to grow at a CAGR of 6.7% to exceed US$31 billion by 2026.