Accessible disease management relies on widespread availability of rapid and accurate diagnostic testing, a need highlighted by the COVID-19 pandemic. While PCR tests offer high accuracy, their effectiveness is hampered by lengthy result times. Rapid antigen tests (RATs) can provide quick results but may lack accuracy. To address these challenges, isothermal amplification and Fast PCR testing have emerged as promising alternatives for decentralized testing.
Our team is developing accessible, rapid, and accurate molecular diagnostics. Within this, a major focus has been simplifying sample preparation, especially important in decentralized testing settings. We created TNA-Cifer Reagent E (BioCifer, QLD) to streamline sample preparation for both DNA and RNA within 2-10 minutes, expediting downstream PCR or isothermal amplification.
We optimized TNA-Cifer Reagent E's protocol for various sample types and demonstrated it can inactivate pathogens, including SARS-CoV-2, Hendra, Nipah, dengue, and Zika viruses, as well as Gram-negative and Gram-positive bacteria. These results are crucial in establishing the biosafety and reliability of our sample preparation solution for detecting dangerous pathogens outside a traditional laboratory setting. We also successfully managed the commercial production of TNA-Cifer Reagent E, to make it an accessible component for decentralized testing, supporting low-resource laboratories and simplifying existing hardware options for other manufacturers.
Integrating TNA-Cifer Reagent E with isothermal amplification and lateral flow detection can enable very low resource (almost electronics-free) disease detection. We have demonstrated this across various pathogens and sample types, including Plasmodium falciparum in infected mosquitoes, Hendra and Nipah virus in viral transport media, prawn hepatopancreatic parvovirus in prawn tissue, Zika virus in urine, dengue virus in serum, plasma, and infected mosquitoes, and even insecticide resistance in mosquitoes. Additionally, leveraging Fast PCR, we've showcased high-throughput sample processing, such as SARS-CoV-2 detection using the portable and economical Mic PCR machine and Myra Robot (Bio Molecular Systems, QLD).
Our diagnostic solutions provide significant progress towards accessible decentralized testing, offering promising avenues for enhanced disease management in resource-limited settings. However, achieving the full potential of these innovations requires careful consideration of community requirements. This involves identifying and addressing barriers such as cost-effectiveness, testing workflows, regulatory hurdles, and fostering trust and acceptance.