Sterility testing of platelet concentrates prepared from deliberately infected blood donations

BACKGROUND:  In general the bacterial count in freshly donated blood is low and even lower in the corresponding platelet concentrates (PCs). By use of flow cytometry (FACS) for sterility testing, the reliability of early versus later sampling times was evaluated. STUDY DESIGN AND METHODS:  Blood don...

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Veröffentlicht in:Transfusion (Philadelphia, Pa.) Pa.), 2006-03, Vol.46 (3), p.486-491
Hauptverfasser: Mohr, Harald, Lambrecht, Bernd, Bayer, Anette, Spengler, Hans-Peter, Nicol, Sven-Boris, Montag, Thomas, Müller, Thomas H.
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container_end_page 491
container_issue 3
container_start_page 486
container_title Transfusion (Philadelphia, Pa.)
container_volume 46
creator Mohr, Harald
Lambrecht, Bernd
Bayer, Anette
Spengler, Hans-Peter
Nicol, Sven-Boris
Montag, Thomas
Müller, Thomas H.
description BACKGROUND:  In general the bacterial count in freshly donated blood is low and even lower in the corresponding platelet concentrates (PCs). By use of flow cytometry (FACS) for sterility testing, the reliability of early versus later sampling times was evaluated. STUDY DESIGN AND METHODS:  Blood donations were spiked with various numbers of Staphylococcus epidermidis, Staphylococcus aureus, Bacillus cereus, and Klebsiella pneumoniae. The corresponding PCs were prepared by the buffy‐coat method and stored at 22°C. A 20‐mL sample was collected from each PC directly after preparation and after 8 hours. Samples were stored at 35°C. Sterility testing of both PCs and samples was by FACS analysis at different time points. RESULTS:  All stored PCs were found positive by FACS analysis, with detection times ranging between 8 and 24 hours (K. pneumoniae, B. cereus), 8 and 91 hours (S. aureus), and 144 hours (S. epidermidis). In the samples incubated at 35°C, bacteria were detected after 8 to 19 hours (K. pneumoniae, B. cereus), 8 to 67 hours (S. aureus), and 19 to 43 hours (S. epidermidis). Some of the samples did not contain bacteria. CONCLUSION:  Detection times for slow‐growing bacteria are significantly shortened when PC samples are incubated at 35°C: The numbers of bacteria in freshly prepared PCs may, however, be so low that the samples drawn for sterility testing do not contain a single bacterium. Our results do not support a shortening of the 24‐hour or greater sampling time recommended by the manufacturers of established test systems, because also for consistent detection by FACS, bacteria need to grow in the PCs to sufficient numbers.
doi_str_mv 10.1111/j.1537-2995.2006.00747.x
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By use of flow cytometry (FACS) for sterility testing, the reliability of early versus later sampling times was evaluated. STUDY DESIGN AND METHODS:  Blood donations were spiked with various numbers of Staphylococcus epidermidis, Staphylococcus aureus, Bacillus cereus, and Klebsiella pneumoniae. The corresponding PCs were prepared by the buffy‐coat method and stored at 22°C. A 20‐mL sample was collected from each PC directly after preparation and after 8 hours. Samples were stored at 35°C. Sterility testing of both PCs and samples was by FACS analysis at different time points. RESULTS:  All stored PCs were found positive by FACS analysis, with detection times ranging between 8 and 24 hours (K. pneumoniae, B. cereus), 8 and 91 hours (S. aureus), and 144 hours (S. epidermidis). In the samples incubated at 35°C, bacteria were detected after 8 to 19 hours (K. pneumoniae, B. cereus), 8 to 67 hours (S. aureus), and 19 to 43 hours (S. epidermidis). Some of the samples did not contain bacteria. CONCLUSION:  Detection times for slow‐growing bacteria are significantly shortened when PC samples are incubated at 35°C: The numbers of bacteria in freshly prepared PCs may, however, be so low that the samples drawn for sterility testing do not contain a single bacterium. Our results do not support a shortening of the 24‐hour or greater sampling time recommended by the manufacturers of established test systems, because also for consistent detection by FACS, bacteria need to grow in the PCs to sufficient numbers.</description><identifier>ISSN: 0041-1132</identifier><identifier>EISSN: 1537-2995</identifier><identifier>DOI: 10.1111/j.1537-2995.2006.00747.x</identifier><identifier>PMID: 16533294</identifier><identifier>CODEN: TRANAT</identifier><language>eng</language><publisher>Malden, USA: Blackwell Publishing Inc</publisher><subject>Anesthesia. Intensive care medicine. Transfusions. 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By use of flow cytometry (FACS) for sterility testing, the reliability of early versus later sampling times was evaluated. STUDY DESIGN AND METHODS:  Blood donations were spiked with various numbers of Staphylococcus epidermidis, Staphylococcus aureus, Bacillus cereus, and Klebsiella pneumoniae. The corresponding PCs were prepared by the buffy‐coat method and stored at 22°C. A 20‐mL sample was collected from each PC directly after preparation and after 8 hours. Samples were stored at 35°C. Sterility testing of both PCs and samples was by FACS analysis at different time points. RESULTS:  All stored PCs were found positive by FACS analysis, with detection times ranging between 8 and 24 hours (K. pneumoniae, B. cereus), 8 and 91 hours (S. aureus), and 144 hours (S. epidermidis). In the samples incubated at 35°C, bacteria were detected after 8 to 19 hours (K. pneumoniae, B. cereus), 8 to 67 hours (S. aureus), and 19 to 43 hours (S. epidermidis). Some of the samples did not contain bacteria. CONCLUSION:  Detection times for slow‐growing bacteria are significantly shortened when PC samples are incubated at 35°C: The numbers of bacteria in freshly prepared PCs may, however, be so low that the samples drawn for sterility testing do not contain a single bacterium. Our results do not support a shortening of the 24‐hour or greater sampling time recommended by the manufacturers of established test systems, because also for consistent detection by FACS, bacteria need to grow in the PCs to sufficient numbers.</description><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>Bacteria - cytology</subject><subject>Bacteria - growth &amp; development</subject><subject>Bacterial Infections</subject><subject>Bacteriological Techniques</subject><subject>Biological and medical sciences</subject><subject>Blood coagulation. 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Psychology</topic><topic>Hot Temperature</topic><topic>Humans</topic><topic>Infection Control - methods</topic><topic>Intensive care medicine</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Molecular and cellular biology</topic><topic>Platelet</topic><topic>Sensitivity and Specificity</topic><topic>Time Factors</topic><topic>Transfusions. Complications. Transfusion reactions. Cell and gene therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mohr, Harald</creatorcontrib><creatorcontrib>Lambrecht, Bernd</creatorcontrib><creatorcontrib>Bayer, Anette</creatorcontrib><creatorcontrib>Spengler, Hans-Peter</creatorcontrib><creatorcontrib>Nicol, Sven-Boris</creatorcontrib><creatorcontrib>Montag, Thomas</creatorcontrib><creatorcontrib>Müller, Thomas H.</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Transfusion (Philadelphia, Pa.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mohr, Harald</au><au>Lambrecht, Bernd</au><au>Bayer, Anette</au><au>Spengler, Hans-Peter</au><au>Nicol, Sven-Boris</au><au>Montag, Thomas</au><au>Müller, Thomas H.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sterility testing of platelet concentrates prepared from deliberately infected blood donations</atitle><jtitle>Transfusion (Philadelphia, Pa.)</jtitle><addtitle>Transfusion</addtitle><date>2006-03</date><risdate>2006</risdate><volume>46</volume><issue>3</issue><spage>486</spage><epage>491</epage><pages>486-491</pages><issn>0041-1132</issn><eissn>1537-2995</eissn><coden>TRANAT</coden><abstract>BACKGROUND:  In general the bacterial count in freshly donated blood is low and even lower in the corresponding platelet concentrates (PCs). By use of flow cytometry (FACS) for sterility testing, the reliability of early versus later sampling times was evaluated. STUDY DESIGN AND METHODS:  Blood donations were spiked with various numbers of Staphylococcus epidermidis, Staphylococcus aureus, Bacillus cereus, and Klebsiella pneumoniae. The corresponding PCs were prepared by the buffy‐coat method and stored at 22°C. A 20‐mL sample was collected from each PC directly after preparation and after 8 hours. Samples were stored at 35°C. Sterility testing of both PCs and samples was by FACS analysis at different time points. RESULTS:  All stored PCs were found positive by FACS analysis, with detection times ranging between 8 and 24 hours (K. pneumoniae, B. cereus), 8 and 91 hours (S. aureus), and 144 hours (S. epidermidis). In the samples incubated at 35°C, bacteria were detected after 8 to 19 hours (K. pneumoniae, B. cereus), 8 to 67 hours (S. aureus), and 19 to 43 hours (S. epidermidis). Some of the samples did not contain bacteria. CONCLUSION:  Detection times for slow‐growing bacteria are significantly shortened when PC samples are incubated at 35°C: The numbers of bacteria in freshly prepared PCs may, however, be so low that the samples drawn for sterility testing do not contain a single bacterium. Our results do not support a shortening of the 24‐hour or greater sampling time recommended by the manufacturers of established test systems, because also for consistent detection by FACS, bacteria need to grow in the PCs to sufficient numbers.</abstract><cop>Malden, USA</cop><pub>Blackwell Publishing Inc</pub><pmid>16533294</pmid><doi>10.1111/j.1537-2995.2006.00747.x</doi><tpages>6</tpages></addata></record>
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subjects Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
Bacteria - cytology
Bacteria - growth & development
Bacterial Infections
Bacteriological Techniques
Biological and medical sciences
Blood coagulation. Blood cells
Blood Donors
Blood Platelets - cytology
Blood Platelets - microbiology
Blood Preservation - methods
Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis
Emergency and intensive cardiocirculatory care. Cardiogenic shock. Coronary intensive care
Female
Flow Cytometry - methods
Fundamental and applied biological sciences. Psychology
Hot Temperature
Humans
Infection Control - methods
Intensive care medicine
Male
Medical sciences
Molecular and cellular biology
Platelet
Sensitivity and Specificity
Time Factors
Transfusions. Complications. Transfusion reactions. Cell and gene therapy
title Sterility testing of platelet concentrates prepared from deliberately infected blood donations
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