TEST CATALOG ORDERING & RESULTS SPECIMEN HANDLING CUSTOMER SERVICE EDUCATION & INSIGHTS
Test Catalog

Test ID: CFRCS    
Bacterial Culture, Cystic Fibrosis with Antimicrobial Susceptibilities, Varies

Useful For Suggests clinical disorders or settings where the test may be helpful

Detection of aerobic bacterial pathogens in specimens from patients with cystic fibrosis

 

Determining the in vitro antimicrobial susceptibility of potentially pathogenic aerobic bacteria, if appropriate

Testing Algorithm Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

When this test is ordered, the reflex tests may be performed and charged. Antimicrobial agent appropriate to the organism and specimen source will be tested according to Mayo's practice and the laboratory's standard operating procedures.

 

See Special Instructions to review the table that provides a listing of the antimicrobials routinely tested in our laboratory as well as antimicrobials that may be tested upon request. These tables are organized by isolate groups and are not all inclusive. Call 800-533-1710 and ask to speak to the Bacteriology Antimicrobial Susceptibility Testing Laboratory if the organism or antimicrobial of interest are not listed in these tables.

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Life expectancy of patients with cystic fibrosis (CF) has increased steadily over the past 50 years, in large part due to improvements in the management of lung disease in this patient population. Still, chronic lung infection is responsible for 75% to 85% of deaths in patients with CF. Appropriate treatment for the causative organism can reduce morbidity and mortality.

 

The number of microbial species associated with CF lung disease is relatively limited. These include Pseudomonas aeruginosa (mucoid and nonmucoid), Staphylococcus aureus, Burkholderia cepacia complex, Stenotrophomonas maltophilia, other nonfermenting Gram-negative rods, Haemophilus influenzae, and Streptococcus pneumoniae. Nontuberculous mycobacteria and Aspergillus species may also play a role in CF lung disease, in addition to common respiratory viruses. This culture, which is specifically designed for CF patients, utilizes conventional and additional selective media (compared to non-CF respiratory cultures) to isolate bacteria commonly associated with pulmonary disease in CF patients. 

 

In selected centers, lung transplantation is performed on CF patients. This test is appropriate for lung transplant patients with underlying CF because they can continue to harbor the same types of organisms as they did prior to transplantation. CF patients may be colonized or chronically infected by these organisms over a long period of time.

 

Antimicrobial susceptibility testing determines the minimal inhibitory concentration (MIC) value of selected antimicrobial agents against isolated potentially pathogenic bacteria. The MIC is the lowest antimicrobial concentration (of a series of increasing concentrations) that inhibits growth of the bacterium. Agar dilution MIC testing is performed by testing for growth of bacteria on agar plates containing varying concentrations of antimicrobial agents.

 

For each organism-antimicrobial agent combination, the Clinical and Laboratory Standards Institute provides interpretive criteria for determining whether the MIC should be interpreted as susceptible, susceptible-dose dependent, intermediate, nonsusceptible, resistant, or epidemiological cutoff value (ECV).

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

No growth or usual flora

 

Identification of probable pathogens

 

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, or nonsusceptible 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 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 depends 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 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 approved literature-supported dosage regimen, 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 within the intermediate range that approach usually attainable blood and 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 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 minimum inhibitory concentration (MIC) that separates microbial populations into those with and without acquired 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. 29th edition CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2019)

Interpretation Provides information to assist in interpretation of the test results

A negative test result is no growth of bacteria or growth of only usual flora. A negative result does not rule out all causes of infectious lung disease (see Cautions).

 

Organisms associated with lower respiratory tract infections are reported.

 

For positive test results, pathogenic bacteria are identified. Patients with cystic fibrosis (CF) may be colonized or chronically infected by some organisms over a long period of time, therefore, positive results must be interpreted in conjunction with previous findings and the clinical picture to appropriately evaluate results.

 

A "susceptible" category result and a low minimum inhibitory concentration value indicate in vitro susceptibility of the organism to the antimicrobial tested.

 

Refer to the "Reference Values" section for interpretation of various categories.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

When culture of sputum is delayed, successful isolation of bacterial pathogens is less likely, due to the overgrowth of usual oropharyngeal flora.

 

Some bacterial agents that cause lower respiratory infections (eg, mycobacteria, Legionella species, Mycoplasma pneumoniae) are not detected by this assay and require special procedures. If the bacterial culture is negative, clinicians should consider additional testing to detect other bacterial, viral, or fungal agents.

 

Results must be interpreted in conjunction with clinical findings and previous culture results.

 

When antimicrobial susceptibilities are performed, in vitro antimicrobial susceptibility does not guarantee clinical response. Therefore, the decision to treat with a particular agent should not be based solely on the antimicrobial susceptibility testing result.

Clinical Reference Recommendations for in-depth reading of a clinical nature

1. Cockerill FR: Conventional and genetic laboratory tests used to guide antimicrobial therapy. Mayo Clin Proc 1998;73:1007-1021

2. York MK, Gilligan P, Alby K: Lower Respiratory Tract Cultures. In Clinical Microbiology Procedures Handbook, Vol 1, Fourth edition. Edited by AL Leber. Washington DC, ASM Press, 2016, Section 3.11.2

3. LiPuma JJ, Currie BJ, Peacock SJ, VanDamme PAR: Chapter 45. Burkholderia, Stenotrophomonas, Ralstonia, Cupriavidus, Pandoraea, Brevundimonas, Comamonas, Delftia, and Acidovorax. In Manual of Clinical Microbiology, 12th edition. Edited by KC Carroll, MA Pfaller. Washington DC, ASM Press, 2019, pp 807-828

4. CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 29th edition. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2019, pp 3-5, 246

Special Instructions Library of PDFs including pertinent information and forms related to the test