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Bacterial culture time to detection in platelet components: An evidence synthesis and estimation of detection failures

ARUP Laboratories, Salt Lake City, Utah, USA. Department of Pathology, University of Utah, Salt Lake City, Utah, USA. Department of Mathematics, University of Utah, Salt Lake City, Utah, USA.

Transfusion. 2022
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PICO Summary

Population

Spiked platelets inoculated into bacterial cultures (16 studies).

Intervention

Systematic review to obtain summary estimates of the time to detection (TTD) for the most common contaminating organisms, and to estimate the risk of detection failures.

Comparison

Outcome

Regression analysis was used to estimate TTD for culture bottles at different inoculum sizes. Detection failures were defined as events in which contaminated components were transfused to a patient. Published data was used on time of transfusion to estimate the risk of detection failures in practice. TTD data were available for 16 different organisms, including 14 in aerobic cultures and 11 in anaerobic cultures. For inocula of 1 colony forming unit, the average TTD for aerobic organisms was 19.2 hours while it was 24.9 hours in anaerobic organisms, but there was substantial overall variation. A hold time of 12 vs. 24 hours had minimal effect for most organisms.
Abstract
BACKGROUND Non-pathogen reduction platelet bacterial risk control strategies in the US FDA guidance include at least one culture. Almost all of these strategies have a culture hold time of ≥12 h. Studies have reported time to detection (TTD) of bacterial cultures inoculated with bacteria from contaminated platelets, but these data and estimates of risk associated with detection failures have not been synthesized. METHODS We performed a literature search to identify studies reporting TTD for samples obtained from spiked platelet components. Using extracted data, regression analysis was used to estimate TTD for culture bottles at different inoculum sizes. Detection failures were defined as events in which contaminated components are transfused to a patient. We then used published data on time of transfusion (ToT) to estimate the risk of detection failures in practice. RESULTS The search identified 1427 studies, of which 16 were included for analysis. TTD data were available for 16 different organisms, including 14 in aerobic cultures and 11 in anaerobic cultures. For inocula of 1 colony forming unit (CFU), the average TTD for aerobic organisms was 19.2 h while it was 24.9 h in anaerobic organisms, but there was substantial overall variation. A hold time of 12 versus 24 h had minimal effect for most organisms. CONCLUSION TTD variation occurs between bacterial species and within a particular species. Under typical inventory management, the relative contribution of culture detection failures is much smaller than the residual risk from sampling failures. Increasing the hold period beyond 12 h has limited value.
Study details
Study Design : Systematic Review
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine