Towards an instrument-free future of molecular diagnostics at the point-of-care

ended

Molecular diagnostics is still primarily a lab-based method. Emerging technologies for application at the point of care (POC) or need, i.e., where a patient or a sample is, have started gaining a big part of the molecular diagnostics market. Interestingly, available methods are divided in two groups: sophisticated instruments for ultra-sensitive temperature-regulated enzymatic amplification of nucleic acids and extremely simple paper-based immuno-diagnostic kits. Complexity, the main disadvantage of the former, results in their poor translation to several applications at the POC. Simplicity, often accompanied by failures, of the latter is the reason for their slow adoption even in resource limited areas. Our vision is an instrument-free approach that combines the advantages of both groups, i.e., a method that does not use heaters or modules that require electricity, infrastructure and maintenance, but, still, takes advantage of enzymatically-amplified nucleic acids detection. To achieve the above, novel diagnostic tools for genetic amplification based on ligases, polymerases and restriction enzymes operating at ambient temperature will be developed, combined with quantitative smartphone colorimetric/UV detection. The global applicability of the new approach will be demonstrated during infectious disease (Influenza and HIV) testing in human samples (blood and swabs) and plant pathogens (Xylella fastidiosa) in plant-tissues. In all cases, we aim for a time-to-result of less than 60 min, demonstrated sensitivities down to the clinically/field relevant values and a final cost in the order of $1 per assay. Combination of Free@POC concept with newly developed predictive models will expand its utility to monitoring disease outbreaks and their spreading. This new generation of instrument-free molecular diagnostics is expected to revolutionize nucleic acid analysis at the POC but also in applications beyond resulting in substantial societal as well as economic benefits.