Detection of bacterial contamination in prestorage culture‐negative apheresis platelets on day of issue with the Pan Genera Detection test

Jacobs, Michael; Smith, Donald J.; Heaton, W. A. L.; Zantek, Nicole D.; Good, Caryn E.

doi:10.1111/j.1537-2995.2011.03308.x

Cited by 119 publications

(153 citation statements)

References 25 publications

(86 reference statements)

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“…[22][23][24] Platelet components are particularly vulnerable to bacterial contamination, mainly due to their storage at room temperature, which allows growth of small inocula to very high titers and limits the shelflife of these products. 12,25 For several decades, efforts have been made at multiple levels to reduce STR and fatalities from bacterially contaminated platelet transfusions, including prevention of contamination during collection and processing, 8,26 culture of platelet products 24 hours after collection, 3,27-29 point-of-issue testing, 27,30,31 as well as pathogen-reduction technologies. 32,33 Introduction of culture of platelet products in 2004 led to a decrease in gram-negative contaminants, which had accounted for one-third of contaminants and twothirds of fatalities.…”

Section: Discussionmentioning

confidence: 99%

Detection of septic transfusion reactions to platelet transfusions by active and passive surveillance

Hong

Xiao

Lazarus

et al. 2016

Blood

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166

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• Bacterial sepsis from contaminated platelet transfusions continues to occur despite recent interventions; additional measures are needed.• STR to platelet transfusion is frequently not recognized or reported; use of recent AABB criteria showed highest diagnostic sensitivity.Septic transfusion reactions (STRs) resulting from transfusion of bacterially contaminated platelets are a major hazard of platelet transfusion despite recent interventions. Active and passive surveillance for bacterially contaminated platelets was performed over 7 years (2007)(2008)(2009)(2010)(2011)(2012)(2013) by culture of platelet aliquots at time of transfusion and review of reported transfusion reactions. All platelet units had been cultured 24 hours after collection and released as negative. Five sets of STR criteria were evaluated, including recent AABB criteria; sensitivity and specificity of these criteria, as well as detection by active and passive surveillance, were determined. Twenty of 51 440 platelet units transfused (0.004%; 389 per million) were bacterially contaminated by active surveillance and resulted in 5 STRs occurring 9 to 24 hours posttransfusion; none of these STRs had been reported by passive surveillance. STR occurred only in neutropenic patients transfused with high bacterial loads. A total of 284 transfusion reactions (0.55%) were reported by passive surveillance. None of these patients had received contaminated platelets. However, 6 to 93 (2.1%-32.7%) of these 284 reactions met 1 or more STR criteria, and sensitivity of STR criteria varied from 5.1% to 45.5%. These results document the continued occurrence of bacterial contamination of platelets resulting in STR in neutropenic patients, failure of passive surveillance to detect STR, and lack of specificity of STR criteria. These findings highlight the limitations of reported national STR data based on passive surveillance and the need to implement further measures to address this problem such as secondary testing or use of pathogen reduction technologies. (Blood. 2016;127(4):496-502)

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Section: Discussionmentioning

confidence: 99%

Detection of septic transfusion reactions to platelet transfusions by active and passive surveillance

Hong

Xiao

Lazarus

et al. 2016

Blood

Self Cite

166

230

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“…Also given PGD has a false positive rate 0.51%, 1 in 196 products would be falsely discarded. 6 As the draft guidance is written, the POI test needs to be repeated every 24 hours, while the culture test would be good for 48 hours. However, a culture method must be initiated on day 4 and the product held for 12 hour, thus losing $12 hours of transfusable life of the platelet, unless the culture method instruction states otherwise.…”

Section: Poi Testingmentioning

confidence: 99%

“…The PGD has a false positive rate of 0.51% and a false negative rate of 1 in 9206. 6 The FDA-reported fatality rates due to bacteria contamination of platelets (both pooled and apheresis) range from 1 to 4 per year from 2011 to 2015 in ;2.1 million annual platelets transfused. 7,8 Staphylococcus aureus was the contaminant in the majority of contaminated apheresis platelets.…”

Section: Introductionmentioning

confidence: 99%

Implications of the US Food and Drug Administration draft guidance for mitigating septic reactions from platelet transfusions

et al. 2017

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“…Further disadvantages of the PGD assay are the costs, a high rate of false-positive results [23] and, currently, the subjective result interpretation [42]. This assay has been evaluated in various studies for use in quality control of PCs [43,44,45]. In January 2011, the AABB approved a new standard (5.1.5.1.1) in which the PGD test is recommended as an option for meeting the intent of this standard [46].…”

Section: Diagnostic Methods - Bacterial Screening Strategiesmentioning

confidence: 99%

“…Currently, the 3 rapid methods, the BactiFlow, NAT and PGD systems, have been routinely evaluated and have been shown to be feasible for bacterial screening of PCs [35,36,43,44,50,55,56,57]. The performance of the PGD assay comes closest to a bedside test; however, the comparably low sensitivity of >10 3 CFU/ml indicates that this method is acceptable only if the screened PCs are transfused immediately after testing.…”

Section: Diagnostic Methods - Bacterial Screening Strategiesmentioning

confidence: 99%

Diagnostic Methods for Platelet Bacteria Screening: Current Status and Developments

Störmer

Vollmer

2013

Transfus Med Hemother

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Bacterial contamination of blood components and the prevention of transfusion-associated bacterial infection still remains a major challenge in transfusion medicine. Over the past few decades, a significant reduction in the transmission of viral infections has been achieved due to the introduction of mandatory virus screening. Platelet concentrates (PCs) represent one of the highest risks for bacterial infection. This is due to the required storage conditions for PCs in gas-permeable containers at room temperature with constant agitation, which support bacterial proliferation from low contamination levels to high titers. In contrast to virus screening, since 1997 in Germany bacterial testing of PCs is only performed as a routine quality control or, since 2008, to prolong the shelf life to 5 days. In general, bacterial screening of PCs by cultivation methods is implemented by the various blood services. Although these culturing systems will remain the gold standard, the significance of rapid methods for screening for bacterial contamination has increased over the last few years. These new methods provide powerful tools for increasing the bacterial safety of blood components. This article summarizes the course of policies and provisions introduced to increase bacterial safety of blood components in Germany. Furthermore, we give an overview of the different diagnostic methods for bacterial screening of PCs and their current applicability in routine screening processes.

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Detection of bacterial contamination in prestorage culture‐negative apheresis platelets on day of issue with the Pan Genera Detection test

Cited by 119 publications

References 25 publications

Detection of septic transfusion reactions to platelet transfusions by active and passive surveillance

Detection of septic transfusion reactions to platelet transfusions by active and passive surveillance

Implications of the US Food and Drug Administration draft guidance for mitigating septic reactions from platelet transfusions

Diagnostic Methods for Platelet Bacteria Screening: Current Status and Developments

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