Purpose: This document summarizes the results of the probiotic enumeration method validation for the Total Cell Count for Probiotic Products Containing Lactobacillus app. stains. The following parameters need to be assessed during this procedure: Accuray, Intermediate precision, repeatability, ruggedness, Linearity, range, and bias.

Accuracy refers to the measure of closeness or nearness of an analytical result to the true value. Precision refers to the consistency or repeatability of the results. Mean refers to the sum of all values in a sample divided by the number of values included in the sum. Standard deviation refers to the quantity calculated to indicate the extent of deviation for a group as a whole. The coefficient of variation refers to the ratio of the standard deviation to the mean. t_lin refers to the t-score of the linearity, t_bias refers to the t-store of the bias, and t_critical refers to the critical t-score.

A control sample with a CoA 3.85E+11 from DuPont was tested using the procedure. The below samples from the same lot number were tested for 20 days. Determined the mean and standard deviation to check for acceptability within +- 20% of the CoA. Using the control sample, demonstrate the linearity of the method and the bias, then graph it.

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