title: The international experience of bacterial screen testing of platelet components with an automated microbial detection system: a need for consensus testing and reporting guidelines.
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 10000 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 10606 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.
authors.affiliation: American Red Cross Biomedical Services, Medical Office, Rockville, MD. Electronic address: richard.benjamin@redcross.org.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Benjamin
authors.affiliation: National Bacteriology Laboratory, NHS Blood and Transplant, London, UK. Electronic address: carl.mcdonald@nhsbt.nhs.uk.
authors.forename: Carl P
authors.initials: CP
authors.lastname: McDonald
mesh_terms: D000465:Algorithms; D001331:Automation; D001424:Bacterial Infections / Q000175:diagnosis* / Q000517:prevention & control; D001771:Blood Banks; D001792:Blood Platelets / Q000382:microbiology*; D001793:Blood Preservation / Q000379:methods; D015169:Colony Count, Microbial / Q000295:instrumentation* / Q000379:methods* / Q000592:standards; D005189:False Positive Reactions; D006801:Humans; D007391:International Cooperation; D015203:Reproducibility of Results