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ASTM E2197: Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals (modified)

Purpose and Goals

  • Evaluate and compare the antimicrobial efficacies of a disinfection product or device against a variety of microbes in different test conditions in laboratory-controlled testing.

Materials and Methods

  • Stainless steel discs (20 mm diameter) will be inoculated with a liquid microbial suspension, dried, and then placed at specified test locations for exposure to the disinfection device. After exposure, the microbes from each disc will be recovered into a solution which will be dilution-plated to provide quantifiable viable microbial burden data for each disc tested. 
  • Testing will include 5% organic soil (serum) in the inoculum solution unless otherwise requested.
  • Each test will include one microbial strain:
    • Staphylococcus aureus​ ATCC 6538 (a standard test strain) Gram-positive bacteria
    • Methicillin-resistant ​Staphylococcus aureus​ ATCC 33592 (MRSA) Gram-positive bacteria
    • Klebsiella pneumoniae ATCC 4352 (a standard test strain) Gram-negative bacteria
    • Carbapenem-resistant Klebsiella pneumoniae ATCC BAA-1705 (KPC, CRE) Gram-negative bacteria
    • Candida auris CDC B11903 fungus 
    • Staphylococcus epidermidis ATCC 35984 Gram-positive bacteria
    • Salmonella enterica ATCC 10708 (formerly known as ​S. choleraesuis​) Gram-negative bacteria
    • Salmonella enterica​ ATCC 14028 (formerly known as ​S. typhimurium​) Gram-negative bacteria
    • Shigella flexneri ATCC 12022 Gram-negative bacteria
    • Escherichia coli ATCC 25922 (a standard test strain) Gram-negative bacteria
    • Escherichia coli ATCC 43888 (an O157:H7 strain) Gram-negative bacteria
    • Listeria monocytogenes ATCC 7644 Gram-positive bacteria
    • Pseudomonas aeruginosa ATCC 9027 or 15442 Gram-negative bacteria
    • Legionella pneumophilia subsp. pneumophilia ATCC 33152 Gram-negative bacteria
    • Bacillus subtilis ATCC 19659 or 6633 Gram-positive bacterial spores
    • Clostridioides difficile ATCC BAA-1870 or 43598 (formerly known as Clostridium difficile) Gram-positive bacterial spores
    • Human Coronavirus strain OC43 (HCoV-OC43) ATCC VR-1558, an enveloped RNA betacoronavirus like the recent pandemic strain SARS-CoV-2
    • Human Coronavirus strain 229E (HCoV-229E) ATCC VR-740, an enveloped RNA alphacoronavirus
    • Human Coronavirus strain NL63 (HCoV-NL63) NIAID-BR NR-470, an enveloped RNA alphacoronavirus
    • Influenzavirus A (H1N1) ATCC VR-1469, an enveloped RNA virus
    • Influenzavirus A (H3N2) ATCC VR-1680, an enveloped RNA virus
    • Feline Calicivirus (FCV) strain F-9 ATCC VR-782, a non-enveloped RNA virus laboratory surrogate for human norovirus 
  • Each test will include 39 total discs:
    • 13 disc locations within ResInnova’s Mock Hospital Suite:
      • 9 disc locations within the mock hospital patient room
      • 3 disc locations within the mock bathroom
      • 1 unexposed control disc 
    • 1 exposure setting: TBD minutes. 
    • 3 replicate discs will be tested for each testing condition (sample size n=3).
  • Alternate strains can be validated for testing upon request for a New Strain Fee. 
  • Optional GLP services are available for an additional fee.
  • Optional UV dosimeter and/or radiometer data collection and analysis are available for an additional fee, with pricing dependent on the device(s) requested (please inquire).

Data Analysis

  • Data will be calculated to determine the quantifiable bacterial/fungal burden in colony-forming units per disc (CFU/disc) or viral burden in plaque- or foci-forming units per disc (PFU/disc or FFU/disc) remaining on each test location.
  • Data will be analyzed to determine the consistency between replicate discs (sample size n=3).
  • Data will be analyzed to compare the efficacies of each testing condition to determine the percent reductions and log reductions of microbial burdens compared to unexposed discs.

Typical Turn Around Time

  • Bacterial/fungal (per strain): 4-6 weeks following receipt of the test devices.
  • Viral (per strain): 6-8 weeks following receipt of the test devices