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The BD BACTEC FX blood culture system with the gentlemacs dissociator is suitable for sterility testing of heart valve and vascular allografts—A validation study

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Abstract

To present our validation study of the BD BACTEC FX blood culture system for sterility testing of cardiovascular tissues aimed for human application. For operational qualification, we performed temperature mapping of the system, vacuum test using non-inoculated BACTEC vials, and growth promotion tests by injecting contaminant strains into aerobic and anaerobic bottles. For performance qualification, negative control, assessment of method suitability, evaluation of sensitivity limits, control of neutralization of antibiotics in biopsy samples from allografts and tissue toxicity effects, were performed. Tissue samples and transport/cryopreservation solutions were homogenized in GentleMACS Dissociator and injected into BACTEC Plus aerobic and anaerobic vials for incubation at 35 °C for 14 days. Tissues were spiked with aerobic and anaerobic bacteria and fungi. Growth of contaminants appeared in all aerobic and anaerobic vials for Staphylococcus aureus, Staphylococcus epidermidis, Bacillus subtilis, Enterococcus faecalis, Escherichia coli and Pseudomonas aeruginosa; in anaerobic vials for Cutibacterium (Propionibacterium) acnes and Clostridium sporogenes; and only in aerobic vials for Candida albicans and Aspergillus brasiliensis. The majority of bacterial strains were detected within two days (59–100%), exceptionally between 3 and 14 days. In contrast, fungal contaminations were detected within 2, 3–6, 7–10 and after 10 days of incubation in 33.3, 71.6, 96.6 and 99.9% of cases,respectively. Uninhibited growth appeared in the tissue biopsies and homogenized tissues with and without antibiotics and in other solutions. BD BACTEC blood culture system with GentleMACS Dissociator is a rapid and efficient tool for detection of contamination in cardio-vascular tissues aimed for human application.

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Funding

There was no external funding used for this validation paper. As this work was carried out for validation of the system identified to be used for sterility testing of cardio-vascular allografts that are processed by our TE, all costs of the tests were covered by our TE.

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Authors and Affiliations

  1. European Homograft Bank (EHB), UCL Saint Luc Clinics, Brussels, Belgium

    Ramadan Jashari, Sarah Vanzeebroeck, Naziha Ben Said, Vanessa Bouzet & Stefano Mastrobuoni

  2. Medical Microbiology, Franciscus Gasthuis and Vlietland, Rotterdam, The Netherlands

    Pieter Petit

  3. Department of Clinical Biology, UCL Saint Luc Clinics, Brussels, Belgium

    Hector Rodriguez-Villalobos

  4. Clinical Lead, Tissues, Cells and Advanced Therapeutics Scottish National Blood Transfusion Service, Scottland, UK

    Sharon Zahra

Authors
  1. Ramadan Jashari
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  2. Sarah Vanzeebroeck
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  3. Pieter Petit
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  4. Hector Rodriguez-Villalobos
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  5. Sharon Zahra
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  6. Naziha Ben Said
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  7. Vanessa Bouzet
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  8. Stefano Mastrobuoni
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Corresponding author

Correspondence to Ramadan Jashari.

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Conflict of interest

The author declare that there is no conflict of interest for any of them. Dr. Jashar is a Director and Manage of Human Body Material of the EHB.

Ethical approval

The cardio-vascular tissues used for this validation study, were assessed for processing as allografts for clinical application. However, as they were morphologically not suitable for clinical application and subsequently identified for discard, they were used as “validation material” in the study. Informed consent was available for each donor of these tissues.

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Jashari, R., Vanzeebroeck, S., Petit, P. et al. The BD BACTEC FX blood culture system with the gentlemacs dissociator is suitable for sterility testing of heart valve and vascular allografts—A validation study. Cell Tissue Bank 22, 453–466 (2021). https://doi.org/10.1007/s10561-020-09893-6

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  • DOI: https://doi.org/10.1007/s10561-020-09893-6

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