ADESSO: a rapid, adaptable and sensitive Cas13-based COVID-19 diagnostic platform

medrxiv(2021)

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摘要
SARS-CoV-2 is the causative agent for a pandemic that has had immense consequences for the health and economic sectors worldwide. While PCR testing and later antigen tests have proven critical for helping to stem the spread of the virus, these methods suffer from general applicability and sensitivity, respectively. Moreover, the emergence of variant strains creates the need for flexibility to correctly and efficiently diagnose the presence of substrains in the population. To address these needs we have developed the diagnostic test ADESSO (Accurate Detection of Evolving SARS-CoV-2 through SHERLOCK Optimization) which employs the Cas13 system to diagnose patients in as little as 1 hour without sophisticated equipment. Using an extensive panel of clinical samples, we demonstrate that ADESSO correctly identifies COVID-19 positive samples at a sensitivity and specificity comparable to RT-qPCR on extracted RNA and higher than antigen tests for unextracted samples. Taken together, ADESSO is a fast, sensitive and cheap method that can be applied in a point of care (POC) setting to diagnose COVID-19 and can be quickly adjusted to detect new variants. ### Competing Interest Statement The DKFZ has filed patent applications regarding this diagnostic methodology (EP 20 173 912.5). RP, FNP and BC are inventors on the above-mentioned patent applications. ### Funding Statement The work was supported by a grant from the Ministry of Science, Research and the Arts of Baden-Wuerttemberg for COVID-19 research (grant agreement no. Kap. 1499 TG 93 to Dr. Riccardo Pecori, Prof. Dr. Nina Papavasiliou (DKFZ) and Prof. Dr. Thomas Miethke (Medical Faculty of Mannheim)) ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Ethics Committee II of the University of Heidelberg (Medical Faculty of Mannheim) ruled the ethics for all the clinical samples used in this study. The committee reviewed and approved the proposal for the collection and use of gargle fluids (ref. 2020-556N). Regarding the use of nose-throat samples, the ethic committee reviewed that proposal and concluded that according to the professional code of conduct for doctors and germans regulations, the evaluation by an ethics committee is unnecessary. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All the data will be available after the publication of this article.
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