Reference Values

No growth, Organism present <10,000 cfu/mL, or mixed flora.

Identification of probable pathogens with colony count ranges.

When antimicrobial susceptibilities are performed, results are reported as minimal inhibitory concentration (MIC) in mcg/mL. Breakpoints (also known as "clinical breakpoints") are used to categorize an organism as susceptible, susceptible-dose dependent, intermediate, resistant, nonsusceptible, or epidemiological cutoff value according to the Clinical and Laboratory Standards Institute (CLSI) guidelines.

In some instances an interpretive category cannot be provided based on available data and the following comment will be included: "There are no established interpretive guidelines for agents reported without interpretations."

Susceptible (S):

A category defined by a breakpoint that implies that isolates with an MIC at or below or a zone diameter the susceptible breakpoint are inhibited by the usually achievable concentrations of antimicrobial agent when the dosage recommended to treat the site of infection is used, resulting in likely clinical efficacy.

Susceptible-Dose Dependent (SDD):

A category defined by a breakpoint that implies that susceptibility of an isolate is dependent on the dosing regimen that is used in the patient. In order to achieve levels that are likely to be clinically effective against isolates for which the susceptibility testing results (either MICs or zone diameters) are in the SDD category, it is necessary to use a dosing regimen (ie, higher doses, more frequent doses, or both) that results in higher drug exposure than that achieved with the dose that was used to establish the susceptible breakpoint. Consideration should be given to the maximum literature-supported dosage regimens, because higher exposure gives the highest probability of adequate coverage of a SDD isolate. The drug label should be consulted for recommended doses and adjustment for organ function.

Intermediate (I):

A category defined by a breakpoint that includes isolates with MICs or zone diameters within the intermediate range that approach usually attainable blood and/or tissue levels and for which response rates may be lower than for susceptible isolates.

Note: The intermediate category implies clinical efficacy in body sites where the drugs are physiologically concentrated or when a higher than normal dosage of a drug can be used. This category also includes a buffer zone, which should prevent small, uncontrolled, technical factors from causing major discrepancies in interpretations, especially for drugs with narrow pharmacotoxicity margins.

Resistant (R):

A category defined by a breakpoint that implies that isolates with an MIC at or above the resistant breakpoint are not inhibited by the usually achievable concentrations of the agent with normal dosage schedules and/or that demonstrate MICs that fall in the range in which specific microbial resistance mechanisms are likely, and clinical efficacy of the agent against the isolate has not been reliably shown in treatment studies.

Nonsusceptible (NS):

A category used for isolates for which only a susceptible breakpoint is designated because of the absence or rare occurrence of resistant strains. Isolates for which the antimicrobial agent MICs are above or the zone diameters are below the value indicated for the susceptible breakpoint should be reported as nonsusceptible.

Note: An isolate that is interpreted as nonsusceptible does not necessarily mean that the isolate has a resistance mechanism. It is possible that isolates with MICs above the susceptible breakpoint that lack resistance mechanisms may be encountered within the wild-type distribution subsequent to the time the susceptible-only breakpoint was set.

Epidemiological Cutoff Value (ECV):

The minimal inhibitory concentration (MIC) that separates microbial populations into those with and without phenotypically detectable resistance (non-wild-type or wild-type, respectively). The ECV defines the highest MIC for the wild type population of isolates. ECVs are based on in vitro data only, using MIC distributions. ECVs are not clinical breakpoints, and the clinical relevance of ECVs for a particular patient has not yet been identified or approved by CLSI or any regulatory agency.

When an ECV is reported, the following comment will be included: "This MIC is consistent with the epidemiological cutoff value (ECV) observed in isolates (WITH/WITHOUT) acquired resistance; however, correlation with treatment outcome is unknown."

(CLSI: Performance Standards for Antimicrobial Susceptibility Testing. 30th ed. CLSI supplement M100. Clinical and Laboratory Standards Institute. 2020)