Multicenter Evaluation of the BD Phoenix CPO Detect Test for Detection and Classification of Carbapenemase-Producing Organisms in Clinical Isolates.

Limited treatment options contribute to high morbidity/mortality rates with carbapenem-resistant, Gram-negative bacterial infections. New approaches for carbapenemase-producing organism (CPO) detection may help inform clinician decision-making on patient treatment and infection control. BD Phoenix CPO detect (CPO detect) detects and classifies carbapenemases in Enterobacterales, Acinetobacter baumannii, and Pseudomonas aeruginosa during susceptibility testing. The clinical performance of CPO detect is reported here. Enterobacterales, Acinetobacter baumannii, and Pseudomonas aeruginosa isolates were evaluated across three sites using CPO detect and a composite reference method (RM); the latter was comprised of the modified carbapenem inactivation method and a MIC screen for ertapenem, imipenem, and meropenem. Multiplex PCR testing was also utilized for Ambler class determination. Positive and negative percentages of agreement (PPA and NPA, respectively) between CPO detect and the RM were determined. The PPA and NPA for Enterobacterales were 98.5% (confidence intervals, 96.6%, 99.4%) and 97.2% (95.8%, 98.2%), respectively. The A. baumannii PPA and NPA, respectively, were 97.1% (90.2%, 99.2%) and 97.1% (89.9%, 99.2%). The P. aeruginosa PPA and NPA, respectively, were 95.9% (88.6%, 98.6%) and 92.3% (86.7%, 95.6%). The PPA values for carbapenemase class designations for all organisms combined and Enterobacterales alone, respectively, were 95.3% (90.2%, 97.8%) and 94.6% (88.8%, 97.5%) for class A, 94.0% (88.7%, 96.6%) and 96.4% (90.0%, 98.8%) for class B, and 95.0% (90.1%, 97.6%) and 99.0% (94.4%, 99.8%) for class D carbapenemases. NPA values for all organisms and Enterobacterales alone ranged from 98.5% to 100%. CPO detect provided accurate detection and classification of CPOs for the majority of isolates of Enterobacterales, Acinetobacter baumannii, and Pseudomonas aeruginosa tested.

A dual-center evaluation of platelet culture vials to detect the presence of microorganisms in platelets.

BACKGROUND: Microorganism contamination of platelets results in a high risk of transfusion-related sepsis. Here, the ability of culture vials (BD BACTEC Platelet Aerobic/F and Platelet Anaerobic/F vials, Becton, Dickinson and Company) to detect microorganisms in leukoreduced apheresis platelets (LRAPs) and leukoreduced whole blood platelet concentrates (LRWBPCs) was assessed. METHODS: LRAPs or LRWBPCs were inoculated into Aerobic/F and Anaerobic/F vials and placed in a blood culturing system (BD BACTEC FX System, Becton, Dickinson and Company) for growth/monitoring over 7 days to detect preexisting contamination during false-positive testing. Subsequently, platelets were seeded with microorganisms at approximately 10 CFU/mL or approximately 1 CFU/mL to simulate contamination. Aerobic/F and Anaerobic/F vials were inoculated with platelets (sets of 12). Microorganism growth was detected in the BACTEC FX instrument over 7 days. Overall, 2925 vials were tested. RESULTS: Of the 1905 vials included in the microorganism detection phase, 63 (3.3%) Aerobic/F and 16 (0.8%) Anaerobic/F vials were both BACTEC FX and subculture negative. From the remaining 1827 vials, two (0.1%) Anaerobic/F vials were false positive; no false positives were observed in Aerobic/F vials, and no false negatives occurred in either vial type. Of the remaining 1825 vials (99.9%), 955 Aerobic/F and 870 Anaerobic/F vials were true positives. The mean-time-to-detection range was 8.5 to 77 hours. All true-positive Aerobic/F and Anaerobic/F vials showed 100% agreement with subculture for positive identification of seeded microorganisms. CONCLUSION: Aerobic/F and Anaerobic/F vials facilitate contamination detection in LRAPs and LRWBPCs down to approximately 1 CFU/mL. These results support the use of Aerobic/F and Anaerobic/F vials for quality control testing of platelets before transfusion.