Standard Practice for Production and Storage of Spores of C. difficile for Use in Efficacy Evaluation of Antimicrobial Agents

Importancia y uso:

5.1 This practice describes a procedure for preparing and storing a suspension of C. difficile spores that meets the following acceptance criteria: (1) spore titer of approximately 5.0 × 10⁸ spores/mL, (2) spore purity of ≥95 %, and (3) a mean log₁₀ reduction (LR) value >5.0 for 3 carriers exposed to 5000 ppm and a mean LR of <3.0 for 3 carriers exposed to 1500 ppm sodium hypochlorite. These acceptance criteria are necessary in order to use the spore suspension to evaluate the performance of antimicrobial formulations using Test Method E3218.

Subcomité:

E35.15

Referida por:

E3218-25, E2895-19R25

Volúmen:

11.08

Número ICS:

07.100.99 (Other standards related to microbiology)

Palabras clave:

Clostridioides difficile; Clostridium difficile; density gradient medium; spore production; spore purity; spore qualification; sporicidal efficacy testing;