Evaluation of the Tempo® System: Improving the Microbiological Quality Monitoring of Human Milk

Abstract

Prime Archives in Medicine: 3 rd Edition 2 www.videleaf.com permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Acknowledgments:The authors would like to thank, Manon Landry for her role in supervising the activities of the human milk bank at Héma-Québec (Montreal), Dr. Gilles Delage, France Bernier, and Jean-François Leblanc for critically reading the manuscript, and bioMérieux Canada for their technical support all along the study.Data Availability Statement: All data sets are stored on a dedicated external hard drive. They can be made available upon request to the corresponding author. Ethics Statement:The studies involving human participants were reviewed and approved by the legal affairs department at Héma-Québec. The patients/participants provided written informed consent to participate in this study.Author Contributions Statement: MPC, MJG, and DB conceived and designed the study and wrote the article. ND collected the data and contributed to the discussion of the results. AL performed the statistical analysis. MC provided suggestions concerning the content of the article and were responsible for critically revising the manuscript. All authors contributed to the article and approved the submitted version.Results: Naturally contaminated milk samples (n = 55) tested for total aerobic flora showed < 1 log (CFU/ml) discrepancy between the two methods in the output results for 98% of the samples. Comparative linear regression analyses demonstrate good correlations between the two methods (R 2 > 0.9). At lower levels of bacterial contamination, the TEMPO ® method precision (C.V. < 8%) and accuracy (> 83%) were comparable to plate counts. Conclusions:The analytical performances of the TEMPO ® system for human milk bacteriological testing are equivalent to the reference plate count method. Results from the TEMPO ® system are available within a 24-h turnaround time from sample inoculation without the need for further supplemental testing, suggesting that this semi-automated method could be implemented within milk bank operations as an in-process monitoring technology to optimize end-product quality and safety.