{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,21]],"date-time":"2026-03-21T00:46:22Z","timestamp":1774053982664,"version":"3.50.1"},"reference-count":24,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2012,2,5]],"date-time":"2012-02-05T00:00:00Z","timestamp":1328400000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2012,8]]},"abstract":"<jats:p><jats:bold>BACKGROUND:<\/jats:bold> Sterility testing of hematopoietic stem cells (HSCs) at The Canadian Blood Services Stem Cell Laboratory is performed using BacT\/ALERT aerobic (SA) culture bottles. This study was conducted to verify the efficacy of this method and to assess the use of the BacT\/ALERT aerobic (BPA) and anaerobic (BPN) culture bottles for microbial testing of HSCs.<\/jats:p><jats:p><jats:bold>STUDY DESIGN AND METHODS:<\/jats:bold> HSC products, including cryopreserved apheresis peripheral blood, marrow, and cord blood and fresh cord blood, were spiked with four aerobic organisms including <jats:italic>Staphylococcus epidermidis, Bacillus cereus<\/jats:italic>, <jats:italic>Pseudomonas aeruginosa<\/jats:italic>, and <jats:italic>Candida albicans<\/jats:italic>, and the anaerobe <jats:italic>Bacteroides fragilis<\/jats:italic> at a target concentration of 100 colony\u2010forming units (CFUs)\/mL. One to 2\u2003mL of pre\u2010 and postspiked samples was inoculated into SA, BPA, and BPN bottles in duplicate and incubated for 5 to 10 days. The presence of the testing organisms in positive culture bottles was confirmed by plating on blood agar.<\/jats:p><jats:p><jats:bold>RESULTS:<\/jats:bold> The BacT\/ALERT system detected the aerobic organisms in all HSCs in SA and BPA bottles within 34.1 hours while <jats:italic>B.\u2003fragilis<\/jats:italic> was detected only in BPN bottles within 68.6 hours. The mean recovered concentration of microorganisms in the HSC products ranged from 55 to 352\u2003CFUs\/mL with the exception of <jats:italic>B.\u2003cereus,<\/jats:italic> which was greater than 10<jats:sup>3<\/jats:sup>\u2003CFUs\/mL.<\/jats:p><jats:p><jats:bold>CONCLUSION:<\/jats:bold> This study shows that the current sterility testing process at the Canadian Blood Services Stem Cell Laboratory detected the tested aerobic but not the anaerobic microbial contaminants in HSCs. The ability of the BacT\/ALERT system using BPA and BPN bottles to detect bacterial contamination in HSCs was also demonstrated.<\/jats:p>","DOI":"10.1111\/j.1537-2995.2011.03530.x","type":"journal-article","created":{"date-parts":[[2012,2,6]],"date-time":"2012-02-06T05:06:01Z","timestamp":1328504761000},"page":"1778-1784","source":"Crossref","is-referenced-by-count":29,"title":["Evaluation of the sterility testing process of hematopoietic stem cells at Canadian Blood Services"],"prefix":"10.1111","volume":"52","author":[{"given":"Cherie","family":"Mastronardi","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lin","family":"Yang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mike","family":"Halpenny","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Baldwin","family":"Toye","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandra","family":"Ram\u00edrez\u2010Arcos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,2,5]]},"reference":[{"key":"e_1_2_8_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.bbmt.2006.06.011"},{"key":"e_1_2_8_3_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2007.01165.x"},{"key":"e_1_2_8_4_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2006.01041.x"},{"key":"e_1_2_8_5_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00302-09"},{"key":"e_1_2_8_6_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1423-0410.2002.00133.x"},{"key":"e_1_2_8_7_2","unstructured":"Food and Drug Administration Center for Biologics Evaluation and Research.Guidance for industry: current good tissue practice (CGTP) and additional requirements for manufacturers of human cells tissues and cellular and tissue\u2010based products (HCT\/Ps).2009. 21 CFR part 1270 and 1271. [cited 2011 Sep 2]. Available from: URL:http:\/\/www.fda.gov\/downloads\/BiologicsBloodVaccines\/GuidanceComplianceRegulatoryInformation\/Guidances\/Tissue\/UCM091408.pdf"},{"key":"e_1_2_8_8_2","volume-title":"Standards for cellular therapy product services","author":"American Association of Blood Banks","year":"2009"},{"key":"e_1_2_8_9_2","unstructured":"Foundation for the Accreditation of Cellular Therapy.International standards for cellular therapy product collection processing and administration accreditation manual. 5thedition.2011. [cited 2011 Sep 2]. Available from: URL:http:\/\/www.factwebsite.org\/uploadedFiles\/FACT_News\/Final%20Draft%205th%20Edition%20Accreditation%20Manual.04.18.11.pdf"},{"key":"e_1_2_8_10_2","unstructured":"General biological products standards\u2014sterility 21 CFR Sect. 610.12.2011. [cited 2011 Nov 14]. Available from: URL:http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=610.12"},{"issue":"1","key":"e_1_2_8_11_2","first-page":"224","article-title":"Screening of cord blood donations in 2010 [abstract]","volume":"101","author":"McDonald CP","year":"2011","journal-title":"Vox Sang"},{"key":"e_1_2_8_12_2","doi-asserted-by":"publisher","DOI":"10.1080\/14653240310004557"},{"key":"e_1_2_8_13_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2006.01041.x"},{"key":"e_1_2_8_14_2","doi-asserted-by":"publisher","DOI":"10.1515\/CCLM.2010.240"},{"key":"e_1_2_8_15_2","volume-title":"SAS system for mixed models","author":"Little RC","year":"1996"},{"key":"e_1_2_8_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2005.09.016"},{"key":"e_1_2_8_17_2","unstructured":"bioM\u00e9rieux Inc.Important notice for BacT\/ALERT users performing platelet quality control testing. bioM\u00e9rieux Connection Newsletter.2004;1:8\u20109. [cited 2011 Sep 29]. Available from: URL:http:\/\/www.biomerieux\u2010usa.com\/upload\/v1n2\u20101.pdf"},{"key":"e_1_2_8_18_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.44.4.1245-1249.2006"},{"key":"e_1_2_8_19_2","unstructured":"McDonaldCP RayA LoweP HartleyS RobbinsS BarbaraAJ.Bacteriological testing of volume reduced cord blood [abstract]. American Society for Microbiology Annual Meeting1999."},{"key":"e_1_2_8_20_2","unstructured":"RodriguezF KhanA.Sterility testing for cellular therapy products. ISCT webinar November 18 2009. [cited 2011 Sep 13]. Available from: URL:http:\/\/www.celltherapysociety.org\/index.php\/meetings\u2010events\/webinars\/2009\u2010webinars\u20102"},{"key":"e_1_2_8_21_2","unstructured":"WallD.Determining and validating acceptable microbial contamination rates for PBSC processing. Peter MacCallum Cancer Centre Australia (oral presentation) 2006."},{"key":"e_1_2_8_22_2","unstructured":"PanterneB.Use of a blood culture method for the microbiological control of cellular products. AFSSAPS (oral presentation).2006."},{"key":"e_1_2_8_23_2","unstructured":"WoodT.Validation of the BacT\/ALERT as an alternative sterility test for Dendreon's autologous cell therapy product. Somatic Cell Therapy Symposium (oral presentation) September 28 2007."},{"key":"e_1_2_8_24_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2011.03187.x"},{"key":"e_1_2_8_25_2","doi-asserted-by":"publisher","DOI":"10.1515\/CCLM.2008.175"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fj.1537-2995.2011.03530.x","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/j.1537-2995.2011.03530.x","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,14]],"date-time":"2023-10-14T01:49:13Z","timestamp":1697248153000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1537-2995.2011.03530.x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,2,5]]},"references-count":24,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2012,8]]}},"alternative-id":["10.1111\/j.1537-2995.2011.03530.x"],"URL":"https:\/\/doi.org\/10.1111\/j.1537-2995.2011.03530.x","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,2,5]]}}}