Volume 60, Issue 1 pp. 126-132
DONOR INFECTIOUS DISEASE TESTING

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

Gerald Denys

Corresponding Author

Gerald Denys

Indiana University School of Medicine, Indianapolis, Indiana

Address correspondence to: Gerald Denys, PhD, D(ABMM), Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, University Hospital, 550 University Blvd., AOC-Room 6129, Indianapolis, IN 46202; e-mail: [email protected].Search for more papers by this author
Anagha Tulpule

Anagha Tulpule

Indiana University School of Medicine, Indianapolis, Indiana

Search for more papers by this author
Jessica Roth

Jessica Roth

Becton, Dickinson and Company, BD Life Sciences – Diagnostic Systems, Sparks, Maryland

Search for more papers by this author
Patty Warns

Patty Warns

Becton, Dickinson and Company, BD Life Sciences – Diagnostic Systems, Sparks, Maryland

Search for more papers by this author
Tiffany Collins

Tiffany Collins

Becton, Dickinson and Company, BD Life Sciences – Diagnostic Systems, Sparks, Maryland

Search for more papers by this author
Susan Mindel

Susan Mindel

Becton, Dickinson and Company, BD Life Sciences – Diagnostic Systems, Sparks, Maryland

Search for more papers by this author
First published: 25 November 2019
Citations: 1
This work was supported by Becton, Dickinson and Company.
The results of this study were previously published in Becton, Dickinson and Company, BD Life Sciences–Diagnostic System's 510K premarket notification filing (BK180211) where equivalence of BD BACTEC Platelet Aerobic/F and Anaerobic/F culture vials to bioMérieux BacT/Alert BPA bottles BK050037 and BD 050043 was shown.

Abstract

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.

CONFLICTS OF INTEREST

AT has disclosed no conflicts of interest. GD received research grants from Becton, Dickinson and Company, BD Life Sciences–Diagnostic Systems; JR, PW, TC, and SM are employees of Becton, Dickinson and Company, BD Life Sciences–Diagnostic Systems, the sponsor of the study.

The full text of this article hosted at iucr.org is unavailable due to technical difficulties.