Abstract
Background: Bacteriological testing of donor human milk is mostly done both before and after pasteurization to control contamination in the end-product and meet the microbiological standards. Although the plate count method represents a reliable and sensitive technique and is considered the gold standard for bacteriological testing, it is recognized for being time-consuming and requiring qualified personnel. Recently, faster testing technologies, mostly geared toward the food industry, have been developed. Among these, the bioMérieux TEMPO® system uses the most probable number method to assess microbiological content in a semi-automated fashion.Objective: The performances of the TEMPO® system in enumerating bacterial quality indicators in human milk were assessed and compared to the reference plate count method.Methods: Naturally and artificially contaminated human milk samples were used to compare the analytical performances of the TEMPO® system to the plate count technique. More specifically, bacteria belonging to the genera Bacillus, Enterobacteriaceae, Staphylococcus aureus, and total aerobic flora were screened using both methods. Bacteria isolated on agar plates containing selective media were identified by supplemental testing. Bacterial testing results and method parameters were compared using linear regression analyses and Bland-Altman approaches.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 (R2 > 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.
Highlights
A human milk diet has multiple, well-established benefits for all infants and reduces many risks associated with prematurity
Since the inception of its Public Mother’s Milk Bank in 2014, Héma-Québec has overseen the milk donation process and is responsible for the processing and distribution of pasteurized donor human milk (PDHM) to premature infants born at 32 weeks or earlier who require medical care and whose mother is unable to breastfeed
Contaminated Milk Samples (NCMS), and uncontaminated milk samples sterilized by pasteurization were spiked with known concentrations of specific bacterial strains and labeled as Artificially Contaminated Milk Samples (ACMS)
Summary
A human milk diet has multiple, well-established benefits for all infants and reduces many risks associated with prematurity. Human milk banks provide an essential source to allow human milk diet for infants whose needs exceed what their own mothers can provide. These institutions need to follow standard safety guidelines regarding end-product bacteriological screening to ensure product safety [1,2,3]. Since the inception of its Public Mother’s Milk Bank in 2014, Héma-Québec has overseen the milk donation process and is responsible for the processing and distribution of pasteurized donor human milk (PDHM) to premature infants born at 32 weeks or earlier who require medical care and whose mother is unable to breastfeed. Bacteriological testing of donor human milk is mostly done both before and after pasteurization to control contamination in the end-product and meet the microbiological standards. The bioMérieux TEMPO® system uses the most probable number method to assess microbiological content in a semi-automated fashion
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