Validation of the Soleris (R) Direct Yeast and Mold Method for Semiquantitative Determination of Yeast and Mold in a Variety of Foods

摘要

A study was carried out to determine the efficacy of the Soleris (R) Direct Yeast and Mold (DYM) automated growth-based method for semiquantitative detection of yeast and mold in a variety of food products. A probability of detection (POD) statistical model was used to compare Soleris results at multiple test thresholds (dilutions) with plate counts determined using the U.S. Food and Drug Administration Bacteriological Analytical Manual, Chapter 18, dilution plating procedure. Fourteen naturally contaminated food products were tested, with Soleris testing performed at three or more threshold levels for each food. Using the POD model, the majority of Soleris test results were in statistical agreement with the reference plating procedures. The exceptions included a single threshold level in yogurt, black pepper, dried fruit, and dry pet food, and two levels in nonfat dry milk and saw palmetto powder. In all but one of these instances, the exception being pet food, the statistical disagreement was due to Soleris estimating a higher level of contamination than the reference method. Results of ruggedness testing showed that the Soleris method produced accurate results even when significant variances in a critical operating parameter, incubation temperature, were introduced. Results of the internal and independent laboratory validation studies showed that the Soleris DYM method can be used as an accurate alternative to conventional dilution plating procedures for evaluation of yeast and mold counts at threshold levels, while saving as much as 72 h in analysis time