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Rapidemic – A lysis buffer for a novel molecular point-of-care diagnostic device for sexually transmitted infections

Periodic Reporting for period 1 - Rapidemic (Rapidemic – A lysis buffer for a novel molecular point-of-care diagnostic device for sexually transmitted infections)

Periodo di rendicontazione: 2023-06-01 al 2023-12-31

Sexually transmitted infections (STI) are among the most prevalent endemic diseases worldwide. The current standard of diagnostics of STI’s is PCR. This technique relies on high-throughput, centralized facilities with expensive equipment and trained personnel. On the other hand, current decentralized (or point-of-care) technologies are severely inaccurate (low sensitivity), and are therefore not used in medical practice.

Centralized diagnostics (like PCR) present important limitations, and risks for patients and public health. When a patient visits a clinic, samples are taken and sent to a lab. Here, the samples are analyzed by trained personnel and the results are communicated back to the clinic. Clinicians then have to call the patient back and ask them to come back for treatment. Due to this system, patients have to wait days to a week before they get a result. For STI’s, this time window allows for further spread of the infections. This delay is also is highly and unnecessarily uncomfortable for the patients in pain, who are experiencing a high degree of uncertainty and shame. Lastly, this delay in treatment administration can have important health consequences for the patient. In 10-15% of women, these infections can quickly lead to pelvic inflammatory diseases, and lead to infertility. Therefore, Rapidemic has developed a technology to address the problem of centralized diagnostics of infectious diseases, starting with diagnostics sexually transmitted infections (STI), like chlamydia (CT) and gonorrhea (NG). Many research papers have already underlined the importance of developing novel fast and accurate molecular test for single-visit STI testing.

Rapidemic develops a novel molecular point-of-care (POC) diagnostic device for quick, easy and accurate diagnosis of chlamydia and gonorrhea. Our technology comprises three steps: lysis, amplification and detection. First the bacteria are broken up to expose the genome. Then, we use a specialized amplification reaction to quickly amplify the DNA. Lastly, the amplified product is run on a lateral flow strip (similar to COVID-tests) for an easy, equipment-free and unequivocal readout.
In this project, Rapidemic's team has been focussing on the development and optimization of a part of their innovative molecular point-of-care assay for fast and accurate diagnosis of highly prevalent sexually transmitted infections. The project related to the sample preparation of the test, mainly to develop a lysis buffer for lysis of gram negative bacteria.
In this project, Rapidemic has been succesful in generating a lysis buffer that is able to lyse pathogens from a sample in a relevant matrix in the matter of a few minutes, and that is highly compatible with our downtream reactions. We are looking into the patentability of our findings.
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