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In this study, we aimed to evaluate the effectiveness of a multiplex ddPCR in detecting bacterial pathogens in the blood of COVID-19 critically ill patients.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This prospective diagnostic study included RT-PCR-confirmed COVID-19 patients admitted to our hospital from December 2022 to February 2023. A multiplex ddPCR assay was used to detect common bacterial pathogens and AMR genes in blood samples of the patients, along with antimicrobial susceptibility testing (AST). The diagnostic performance of the ddPCR assay was evaluated by comparing the results with those obtained through blood culture and clinical diagnosis. Additionally, the ability of ddPCR in detecting bacterial resistance was compared with the AST results.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Of the 200 blood samples collected from 184 patients, 45 (22.5%) were positive using blood culture, while 113 (56.5%) were positive for bacterial targets using the ddPCR assay. The ddPCR assay outperformed blood culture in pathogen detection rate, mixed infection detection rate, and fungal detection rate. <jats:italic>Acinetobacter baumannii<\/jats:italic> and <jats:italic>Klebsiella pneumoniae<\/jats:italic> were the most commonly detected pathogens in COVID-19 critically ill patients, followed by <jats:italic>Enterococcus<\/jats:italic> and <jats:italic>Streptococcus<\/jats:italic>. Compared to blood culture, ddPCR achieved a sensitivity of 75.5%, specificity of 51.0%, PPV of 30.9%, and NPV of 87.8%, respectively. However, there were significant differences in sensitivity among different bacterial species, where Gram-negative bacteria have the highest sensitivity of 90.3%. When evaluated on the ground of clinical diagnosis, the sensitivity, specificity, PPV and NPV of ddPCR were 78.1%, 90.5%, 94.7%, and 65.5%, respectively. In addition, the ddPCR assay detected 23 cases of <jats:italic>bla<\/jats:italic><jats:sub><jats:italic>KPC<\/jats:italic><\/jats:sub>, which shown a better consistent with clinical test results than other detected AMR genes. Compared to <jats:italic>bla<\/jats:italic><jats:sub><jats:italic>KPC<\/jats:italic><\/jats:sub>, there were few other AMR genes detected, indicating that the application of other AMR gene detection in the COVID-19 critically ill patients was limited.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>The multiplex ddPCR assay had a significantly higher pathogen detection positivity than the blood culture, which could be an effective diagnostic tool for BSIs in COVID-19 patients and to improve patient outcomes and reduce the burden of sepsis on the healthcare system, though there is room for optimization of the panels used.- Adjusting the targets to include <jats:italic>E. faecalis<\/jats:italic> and <jats:italic>E. faecium<\/jats:italic> as well as <jats:italic>Candida albicans<\/jats:italic> and <jats:italic>Candida glabrata<\/jats:italic> could improve the ddPCR' s effectiveness. However, further research is needed to explore the potential of ddPCR in predicting bacterial resistance through AMR gene detection.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s15010-023-02157-x","type":"journal-article","created":{"date-parts":[[2023,12,21]],"date-time":"2023-12-21T12:01:57Z","timestamp":1703160117000},"page":"1027-1039","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Clinical evaluation of a multiplex droplet digital PCR for pathogen detection in critically ill COVID-19 patients with bloodstream infections"],"prefix":"10.1007","volume":"52","author":[{"given":"Yanbing","family":"Li","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kangkang","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Yin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zheren","family":"Tan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manli","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiaoyang","family":"Dai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bin","family":"Yi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,12,21]]},"reference":[{"key":"2157_CR1","unstructured":"WHO. 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The medical ethics committee's responsibilities, composition, operations and records are fully compliant with \u201cGuidelines for ethical review of drug clinical trials\u201d (2010), \u201cMethods for ethical review of biomedical research involving human beings\u201d (2016), \u201cStandard for quality control of clinical trials of medical devices\u201d (2016), GCP (2020), ICH-GCP and other related regulations. All participants gave a written informed consent prior to their inclusion in the study and the data were analyzed anonymously.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}