Original Article
The International Experience of Bacterial Screen Testing of Platelet Components With an Automated Microbial Detection System: A Need for Consensus Testing and Reporting Guidelines

https://doi.org/10.1016/j.tmrv.2014.01.001 Get rights and content

Abstract

The BacT/ALERT microbial detection system (bioMerieux, Inc, Durham, NC) is in routine use in many blood centers as a prerelease test for platelet collections. Published reports document wide variation in practices and outcomes. A systematic review of the English literature was performed to describe publications assessing the use of the BacT/ALERT culture system on platelet collections as a routine screen test of more than 10 000 platelet components. Sixteen publications report the use of confirmatory testing to substantiate initial positive culture results but use varying nomenclature to classify the results. Preanalytical and analytical variables that may affect the outcomes differ widely between centers. Incomplete description of protocol details complicates comparison between sites. Initial positive culture results range from 539 to 10 606 per million (0.054%-1.061%) and confirmed positive from 127 to 1035 per million (0.013%-0.104%) donations. False-negative results determined by outdate culture range from 662 to 2173 per million (0.066%-0.217%) and by septic reactions from 0 to 66 per million (0%-0.007%) collections. Current culture protocols represent pragmatic compromises between optimizing analytical sensitivity and ensuring the timely availability of platelets for clinical needs. Insights into the effect of protocol variations on outcomes are generally restricted to individual sites that implement limited changes to their protocols over time. Platelet manufacturers should reassess the adequacy of their BacT/ALERT screening protocols in light of the growing international experience and provide detailed documentation of all variables that may affect culture outcomes when reporting results. We propose a framework for a standardized nomenclature for reporting of the results of BacT/ALERT screening.

Section snippets

Materials and Methods

An online search was performed for all articles citing the keywords “BacT/ALERT” and “platelets” within the PubMed database. The outcome was restricted to English language reports of BacT/ALERT testing performed in blood centers that reported both denominator and numerator data during defined periods and that tested more than 10 000 routine screen tests, thereby excluding earlier smaller research studies [18]. The bibliographies of the resulting reports were then searched for similar articles

Results

Sixteen reports describe the routine use of the BacT/ALERT culture system for the screen testing of platelets in 11 countries reported between 2004 and 2013. Twelve reports describe AP platelets [1], [2], [3], [4], [5], [7], [8], [9], [16], [17], [20], [21], 3 pooled PRP platelets [5], [22], [23], 7 pooled BC platelets [5], [6], [7], [8], [16], [21], [24], [25], [26], and 2 studies are mostly BC platelets with a smaller number of admixed AP [6], [27] (Table 1). The smallest subgroup included

Discussion

BacT/ALERT culture testing is widely used to improve the microbial safety of platelet transfusion yet has never formally been shown in randomized controlled studies to reduce septic transfusion reactions, nor have any controlled trials compared the efficacy of the different protocols currently in use. This also applies to pathogen reduction technologies that may provide an alternative to bacterial screen testing. Culture testing undoubtedly detects and prevents transfusion of a large number of

Acknowledgments

The ISBT TTID Bacterial workgroup includes Drs Richard J. Benjamin (co-lead), Carl McDonald (co-lead), Sandra Ramirez-Arcos, Dirk DeKorte, Michael Jacobs, Andrew Heaton, Erica Wood, Melanie Stoermer, Eva Spindler-Raffel, Christian Gabel, Zbigniew Szczepiorkowski, and Suzanne Marschner. We would like to acknowledge Drs Anne Eder, Jennifer Allen, and Prof John Barbara for critical reading and helpful suggestions and Tracy Ward for secretarial assistance.

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    Conflict of interest: The authors declare no conflicts of interest.

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