Periodic Reporting for period 1 - NARRATE (Novel ApameR-Based Rapid Test Technology for Virus Detection)
Reporting period: 2023-10-01 to 2025-03-31
Lateral flow tests based on antigen-antibody affinity are used in human and veterinary medicine and were conducted in huge numbers during the corona pandemic. Typically, such tests, also called point-of-care (POC) tests, are conducted by patients or non-trained personal and are thought to enable a fast decision making. The range of applications covers infections by viral, bacterial and parasitic pathogens as well as the detection of humoral antibodies related to pregnancy, allergies or autoimmune diseases. However, compared to laboratory tests, POC tests are more expensive and wasteful, since POC test reagents are single-use and the test kits employ a huge amount of sterilized disposables, and moreover, in case of lateral flow tests, the production of antibodies by mammalian cell culture employed in rapid care tests is slow and production costs are comparable high.
The action focused on the development of an aptamer-based rapid test technology, exploiting the highly specific binding of an aptameric sequence to its target molecule. The binding of an aptamer is based on individual nucleic acid sequences that fit (Latin: aptus) by conformation and non-covalent interactions to a molecular counterpart, also termed ligand. Our sensor unit combines the aptameric seqence against the target molecule, with a reporter unit that enables a fast decision making by a fluorescent signal. Within the action, the sensor unit design was optimised in silico, and its performance was validated by experimental testing. We developed a cheap, scalable microbial production process to produce the aptamer sensor unit. The sensor was tested under laboratory and under relevant environmental conditions. We developed a first prototype comprising the sensor unit, the reporter fluorescent signal and stabilizing buffer ingredients.
Within this action we established aptamer based sensors, which are able to bind a specific molecule, e.g a viral antigen and report the outcoming by a fluorescent signal. We analysed the current market and patent situation and evaluated the prerequisites for obtaining approval in accordance with the Medical Devices Regulation. The production process is relying on a cheap microbial process, allowing the development of cheap, easy-to-use rapid care tests. Based on the first prototypes developed within the action we will continue to further establish the aptamer-based rapid test technology.