{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,13]],"date-time":"2025-02-13T05:05:22Z","timestamp":1739423122210,"version":"3.37.0"},"reference-count":32,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2024,12,8]],"date-time":"2024-12-08T00:00:00Z","timestamp":1733616000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100004587","name":"Instituto de Salud Carlos III","doi-asserted-by":"publisher","award":["PI22\u201000290"],"award-info":[{"award-number":["PI22\u201000290"]}],"id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Umbilical cord blood (CB) units stored in banks are an important source of hematopoietic stem cells for transplantation and other cell therapies. New applications, such as their use in transfusions, require rapid quality release as cord blood red blood cells (CB\u2010RBC) have a shorter shelf life.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>This project aims to investigate the most prevalent microbial contaminants in CB preparations and validate a rapid sterility testing strategy for CB\u2010RBC based on an automated system (BACT\/ALERT\u00ae) in tandem with a molecular assay (real\u2010time PCR) capable of detecting at least 100\u2009CFU\/mL of <jats:italic>Cutibacterium acnes<\/jats:italic> in CB\u2010RBC to accelerate the detection of the most common slow\u2010growing bacteria.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Microbial contamination incidence was assessed by reviewing 4696 CB sterility tests, revealing a positivity rate of 3.4%, with <jats:italic>C. acnes<\/jats:italic> being the most common slow\u2010growing pathogen. The BACT\/ALERT\u00ae system, which was validated according to European Pharmacopeia guidelines, was an appropriate method for sterility testing of CB\u2010RBC, although it required up to 14\u2009days of culture to detect <jats:italic>C. acnes<\/jats:italic> when iFAPlus and iFNPlus bottles were used to neutralize antimicrobials. Interestingly, the BACT\/ALERT\u00ae method detected <jats:italic>C. acnes<\/jats:italic> at 30\u2009CFU\/mL within 14\u2009days, while real\u2010time PCR identified concentrations \u226565\u2009CFU\/mL by Day 4.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>In conclusion, we developed a rapid sterility testing strategy that combines automated culture systems and real\u2010time PCR for early microbial contamination, enhancing CB\u2010RBC shelf life for transfusion and emphasizing the importance of combining detection methods.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.18084","type":"journal-article","created":{"date-parts":[[2024,12,9]],"date-time":"2024-12-09T05:44:02Z","timestamp":1733723042000},"page":"140-151","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development of molecular sterility assay for rapid quality release of cord blood erythrocytes units for transfusion"],"prefix":"10.1111","volume":"65","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8007-5077","authenticated-orcid":false,"given":"Laia","family":"Closa","sequence":"first","affiliation":[{"name":"Histocompatibility and Immunogenetics Laboratory Blood and Tissue Bank  Barcelona Spain"},{"name":"Transfusional Medicine Group Vall d'Hebron Research Institute\u2010Autonomous University of Barcelona (VHIR\u2010UAB)  Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5196-2507","authenticated-orcid":false,"given":"Dinara","family":"Samarkanova","sequence":"additional","affiliation":[{"name":"Transfusional Medicine Group Vall d'Hebron Research Institute\u2010Autonomous University of Barcelona (VHIR\u2010UAB)  Barcelona Spain"},{"name":"Cell and Advanced Therapy Service Blood and Tissue Bank  Barcelona 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