Prevention of transfusion of platelet components contaminated with low levels of bacteria:: a comparison of bacteria culture and pathogen inactivation methods

BACKGROUND: This study compared the efficacy of bacterial detection with inactivation for reducing the risk associated with transfusion of platelet (PLT) components contaminated with low levels of bacteria. STUDY DESIGN AND METHODS: Twenty-one double-dose PLTs were spiked with seven species of bacteria at three levels (0.003-0.03, 0.03-0.3, 0.3-3 colony-forming units [CFUs]/mL). After split, each PLT unit contained 1 to 10, 10 to 100, and 100 to 1000 CFUs. One unit was photochemically treated (PCT, 150 mu mol/L amotosalen and 3 J/cm(2) ultraviolet A). The other unit was untreated. All units were stored and sampled on Days 1, 2, and 5 of storage for aerobic and anaerobic culture in the BacT/ALERT system (bioMerieux). PLTs were classified as sterile when no bacterial growth was detected after 120 hours of culture. RESULTS: In all PCT PLTs, no bacteria were detected throughout 5 days of storage regardless of species, level of contamination, and sampling time. In untreated PLTs, Staphylococcus aureus was consistently detected by culturing. Growth of 1 to 10 CFUs per unit Staphylococcus epidermidis, 1 to 100 CFUs per unit of Klebsiella pneumoniae, and 1 to 1000 CFUs per unit Propionibacterium acnes was delayed and only detectable after 5, 2, and 5 days of storage, respectively. Low levels of Streptococcus agalactiae (1-10 CFUs/unit), Escherichia coli (1-100 CFUs/unit), and Clostridium perfringens (1-100 CFUs/unit) were not detected during 5 days of storage, although bacterial outgrowth was detected at higher levels of contamination. CONCLUSIONS: For the seven bacterial species examined, contaminated PLTs may be released for transfusion on test-negative-to-date status. In contrast, bacterial inactivation by PCT could reduce the risk associated with transfusion of PLTs contaminated with low levels of these bacteria.