Development of point-of-care diagnostics kits

Neglected tropical diseases (NTD) receive lesser funding, research focus, and are limited to low-income populations in developing countries. Effective treatment and prevention of infectious diseases requires accurate and timely diagnosis. Current diagnostics are expensive, time consuming, require trained medical staff, sophisticated equipment, and adequate infrastructure – requirements that are often not met in resource limited settings. Hence, there is a great need for simple and cost effective point-of-care (POC) diagnostic tests that do not require skilled users to probe for infectious diseases. Many treatable diseases remain untreated due to this lack of cheap and simple point-of-care tests, which is a common problem faced by many third world countries. We are currently exploring both genomic and non-genomic techniques for POC detection systems for NTD.

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Figure 1: The CRISPR-Cas9 complex detects dsDNA. Upon binding, the complex initiates directional unwinding of the target DNA and subsequent base-pairing with the gRNA. The Cas9 nuclease then cuts the target DNA (both strands)

In one research project, we aim to develop a POC diagnostic test that probes for the presence of pathogenic DNA in body fluids. The key scientific innovation is to use the CRISPR/Cas9 genome-engineering system as a DNA detection tool (Figure 1).

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Figure 9: Schematic of point-of-care diagnostic kit.

We are utilizing the CRISPR-Cas9 technology to develop a molecular system for detecting parasitic nucleic acids and gives a colorimetric readout to be visible to the naked eye- much like a pregnancy test (figure 9). With the scientific expertise of the team, we can develop a cheap and accessible diagnostic tool which will enable people in developing countries to get treatment in the early stages of the disease.
In another research project, we aim to use an electrochemical approach to detect infectious diseases in patient samples. An important consideration for POC diagnostic development in today’s setting is the need to integrate drug resistance detection along with positive disease confirmation. Accurate diagnosis of drug resistant cases in a timely manner would prevent wrong treatment and waste of precious time along with reducing transmission of the resistant strain. Even in cases where accurate diagnosis is provided, the ability to follow up via a POC system can be useful in monitoring the progress of therapy, insuring compliance to medication and preventing relapse. Advancements in electrochemistry, optics, fluidics, and other branches of science have paved the way for developing even smaller and well-integrated biosensor POC devices. Early POC detection will help in predicting disease outbreaks and resistance development.