Neisseria gonorrhoeae in vivo panel with broth MIC

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BIOLOGICAL INFORMATION
BACKGROUND INFORMATION
The Minimum Inhibitory Concentration (MIC) Assay assesses the in vitro antimicrobial potency of the test article(s). In this assay, the protocol for MIC testing with N. gonorrhoeae as developed and validated for assay performance in 96-well plates using appropriate broth medium, GC broth with 1% isovitalex. A panel of N. gonorrhoeae strains was tested (FA1090 ATCC 700825, AR Bank #0179-StrR, AR Bank #0181-StrR, and H041 NCTC 13820-StrR).
NUMBER OF ASSAYS ON PANEL
4
ASSAYS ON PANEL
FAMILY NAME ITEM NUMBER PROTEIN NAME ORGANISM ASSAY SUB TYPE
Neisseria gonorrhoeae FA1090 (ATCC 700825) MIC612501 Gram-negative Bacteria
Neisseria gonorrhoeae Azithromycin Non-Susceptible (CDC & FDA AR Isolate Bank #0179-StrR) MIC612574 Gram-negative Bacteria
Neisseria gonorrhoeae Azithromycin Non-Susceptible (CDC & FDA AR Isolate Bank #0181-StrR) MIC612575 Gram-negative Bacteria
Neisseria gonorrhoeae Ceftriaxone Non-Susceptible (H041 WHO-X StrR) MIC612576 Gram-negative Bacteria
SPECIES
Neisseria gonorrhoeae
ORGANISM
Gram-negative Bacteria
INCUBATION CONDITIONS
Aerobic
ASSAY INFORMATION
ASSAY TYPE
Functional
DETECTION METHOD
2 – 8 x 10⁵ CFU/mL
TESTING INFORMATION
PROCEDURE SUMMARY
The broth method is a 96-well assay format that was developed and validated by PDS for compound-sparing assessment of antibacterial activity against N. gonorrhoeae. The test substance is dissolved in 100% DMSO (or specified vehicle) and diluted by 2-fold serial titrations for a total of 11 concentrations. A 4 µL aliquot of each dilution is added to 196 µL of broth medium seeded with the organism in a 96-well plate (bacterial count, 2-8 x 10⁵ CFU/mL final). The highest test substance concentration is 128 µg/mL (or specified concentration), and the final vehicle concentration is 2 percent. Following incubation, the test plate is visually examined, each well is scored for growth or complete inhibition of growth, and the MIC is then recorded. Each test substance is evaluated in replicate in the same experimental occasion. Vehicle control and an active reference agent are used as blank and positive controls. Alterations to the protocol can be accommodated with advanced notification.
SUBSTRATE
Neisseria gonorrhoeae
ATP CONCENTRATION
GC broth + 1% isovitalex
CRITERIA FOR SIGNIFICANCE
The minimum inhibitory concentration (MIC) that prevents pathogen growth is determined using a broth assay.
TURNAROUND TIME
STANDARD
20 Days
CLINICAL RELEVANCE
THERAPEUTIC AREA
Infectious Disease
ADDITIONAL INFORMATION
BRAND
PDS
TESTING LOCATION
Taiwan - Taipei

 

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