A novel pathogen capture sample preparation device for point of care TB diagnostics on the genedrive molecular diagnostics platform

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Currently there are limited Point-of-Care (PoC)-applicable sample processing methods needed to recover infectious disease targets from clinical samples prior to molecular diagnostic testing. This means analysis is restricted to centralised laboratory facilities and this significantly impacts time to result and subsequent treatment, and cost to the healthcare provider. Many field portable molecular testing systems fail to achieve PoC use as the upstream sample preparation workflows needed to support the them are overly complex, equipment intensive and costly - precluding their deployment in decentralised settings. This project will be technology enabling and will capitalise on our existing derisked workflow that will initially improve sensitivity of our existing test for MTB in decentralised non-laboratory settings by an order of approximately 100-fold. This will enable diagnosis of patients with low levels of bacterial infection and also permit stratification for receipt of appropriate anti-infective treatments. This technology has the opportunity to change the way blood borne viral diagnostics are conducted in decentralised settings in resource limited countries, providing improved patient care and more timely therapy, and ultimately positively impacting on global health challenges in infectious diseases. It seeks to integrate existing technologies to realise a true PoC TB workflow for decentralised use in low-income countries with highest disease burden. The project outcome will be a low cost, sample preparation consumable device that overcomes the traditional user complexity, biosafety and equipment barriers needed for successful PoC application. The device will enable decentralised testing of TB in sputum but will also be broadly applicable for a range of other clinical sample types and infectious disease agents, and in established healthcare settings in developed countries.