Test Catalog

Test Id : HELIS

Helicobacter pylori Culture with Antimicrobial Susceptibilities, Varies

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

Recovery of Helicobacter pylori from gastric specimens for antimicrobial susceptibility testing of the organism (amoxicillin, clarithromycin, levofloxacin, metronidazole, rifampin, and tetracycline are routinely tested)

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
GID Bacteria Identification No, Bill Only No
ISAE Aerobe Ident by Sequencing No, Bill Only No
TISSR Tissue Processing No, Bill Only No
MIC Susceptibility, MIC No, Bill Only No
SUS Susceptibility No, Bill Only No
HPCR1 H pylori + Clarithro Resistance PCR No, Bill Only No

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 at an additional charge.

 

When Helicobacter pylori is isolated, identification will be confirmed, and susceptibility testing performed. The routine susceptibility panel includes amoxicillin, clarithromycin, levofloxacin, metronidazole, rifampin, and tetracycline.

 

In the event that an isolate of Helicobacter pylori does not grow for susceptibility testing, reflex testing for H pylori with clarithromycin resistance prediction may be added.

 

For test utilization options, see Helicobacter pylori Diagnostic Algorithm in Special Instructions.

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

Method Name
A short description of the method used to perform the test

Conventional Culture Technique with Minimal Inhibitory Concentration (MIC) (Agar Dilution or Broth Microdilution or Gradient Diffusion) or Disk Diffusion (if appropriate)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Helicobacter pylori Culture + Susc

Aliases
Lists additional common names for a test, as an aid in searching

H pylori

H. pylori

Amoxicillin

Clarithromycin

Levofloxacin

Metronidazole

Tetracycline

Rifampin

Helicobacter

pylori

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 at an additional charge.

 

When Helicobacter pylori is isolated, identification will be confirmed, and susceptibility testing performed. The routine susceptibility panel includes amoxicillin, clarithromycin, levofloxacin, metronidazole, rifampin, and tetracycline.

 

In the event that an isolate of Helicobacter pylori does not grow for susceptibility testing, reflex testing for H pylori with clarithromycin resistance prediction may be added.

 

For test utilization options, see Helicobacter pylori Diagnostic Algorithm in Special Instructions.

Specimen Type
Describes the specimen type validated for testing

Varies

Shipping Instructions

Specimen must be received in laboratory within 48 hours of collection. Specimen should be collected and packaged as close to shipping time as possible.

Necessary Information

Specimen source is required; include the specific anatomic source.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Preferred:

Specimen Type: Gastric biopsy

Container/Tube: Sterile container

Specimen Volume: 0.5 x 0.2 x 0.2-cm sized piece of tissue

Collection Instructions: Acquire biopsied tissue; moisten with sterile saline.

 

Acceptable:

Specimen Type: Gastric brushings or gastric aspirate

Container/Tube: Sterile container

Specimen Volume: Entire collection or 0.5 mL

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

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Microbiology Test Request (T244)

-Gastroenterology and Hepatology Client Test Request (T728)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Biopsy submitted in fluid other than sterile saline Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) 48 hours

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

Recovery of Helicobacter pylori from gastric specimens for antimicrobial susceptibility testing of the organism (amoxicillin, clarithromycin, levofloxacin, metronidazole, rifampin, and tetracycline are routinely tested)

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 at an additional charge.

 

When Helicobacter pylori is isolated, identification will be confirmed, and susceptibility testing performed. The routine susceptibility panel includes amoxicillin, clarithromycin, levofloxacin, metronidazole, rifampin, and tetracycline.

 

In the event that an isolate of Helicobacter pylori does not grow for susceptibility testing, reflex testing for H pylori with clarithromycin resistance prediction may be added.

 

For test utilization options, see Helicobacter pylori Diagnostic Algorithm in Special Instructions.

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

Helicobacter pylori is a spiral-shaped Gram-negative bacterium that may cause chronic gastritis, peptic ulcer disease, or gastric neoplasia. In adults of industrialized countries, an estimated 0.5% of the susceptible population becomes infected each year, although the incidence has been decreasing over time. The organism may asymptomatically colonize humans.

 

In suspected H pylori-associated disease, the H pylori with clarithromycin resistance prediction polymerase chain reaction (PCR) test or urea breath test is recommended for patients less than 60 years old without alarming signs and symptoms (see Helicobacter pylori Diagnostic Algorithm in Special Instructions). If clarithromycin resistance is predicted by the PCR test, endoscopy with biopsy should be considered for H pylori culture with antimicrobial susceptibility testing. For those greater than or equal to 60 years old or who have alarming signs and symptoms, endoscopy with biopsy is recommended, with consideration for H pylori culture with antimicrobial susceptibility testing on the gastric biopsy. If patients fail to respond to treatment, endoscopy with biopsy should be considered for H pylori culture with antimicrobial susceptibility testing.

 

The Clinical and Laboratory Standards Institute (CLSI) recommends agar dilution for H pylori antimicrobial susceptibility testing. Amoxicillin, clarithromycin, levofloxacin, metronidazole, rifampin, and tetracycline are routinely tested. CLSI has defined interpretive categories for clarithromycin. The antimicrobials for which the European Committee on Antimicrobial Susceptibility Testing defines interpretive categories include amoxicillin, clarithromycin, levofloxacin, metronidazole, rifampin, and tetracycline.

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 after 7 days

 

Susceptibility 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 breakpoint setting organizations, either the Clinical and Laboratory Standards Institute (CLSI) or the European Committee on Antimicrobial Susceptibility Testing (EUCAST), as applicable.

 

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."

 

Clinical and Laboratory Standards Institute (CLSI) Interpretive Category Definitions:

Susceptible:

A category defined by a breakpoint that implies that isolates with an MIC at or below or a zone diameter at or above 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:

A category defined by a breakpoint that implies that susceptibility of an isolate depends on the dosing regimen that is used in the patient. 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 susceptible-dose dependent (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:

A category defined by a breakpoint that includes isolates with MICs or zone diameters within the intermediate range that approach usually attainable blood and tissue levels and/or 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:

A category defined by a breakpoint that implies that isolates with an MIC at or above or a zone diameter at or below the resistant breakpoint are not inhibited by the usually achievable concentrations of the agent with normal dosage schedules and/or that demonstrate MICs or zone diameters 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:

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 after the time the susceptible-only breakpoint was set.

 

Epidemiological Cutoff Value:

The MIC that separates microbial populations into those with and without phenotypically detectable resistance (non-wild-type or wild-type, respectively). The epidemiological cutoff value (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, an interpretive category is not assigned, and 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."

 

Wild-type (WT): An interpretive category defined by an ECV that describes the microbial population with no phenotypically detectable mechanisms of resistance or reduced susceptibility for an antimicrobial agent being evaluated.

 

Non-wild-type (NWT): An interpretive category defined by an ECV that describes the microbial population with phenotypically detectable mechanisms of resistance or reduced susceptibility for the antimicrobial agent being evaluated.

Note: MIC values for which ECV’s are defined are not to be interpreted or reported as susceptible, intermediate or resistant but rather as WT or NWT. The ECV’s should not be used as clinical breakpoints.(Clinical and Laboratory Standards Institute [CLSI]. Performance Standards for Antimicrobial Susceptibility Testing. 31st ed. CLSI supplement M100. CLSI; 2021:4-6, 268-269)

 

European Committee on Antimicrobial Susceptibility Testing (EUCAST) Interpretive Category Definitions:

S - Susceptible, standard dosing regimen: A microorganism is categorized as "Susceptible, standard dosing regimen", when there is a high likelihood of therapeutic success using a standard dosing regimen of the agent.

 

I - Susceptible, increased exposure*: A microorganism is categorized as "Susceptible, Increased exposure*" when there is a high likelihood of therapeutic success because exposure to the agent is increased by adjusting the dosing regimen or by its concentration at the site of infection.

 

R - Resistant: A microorganism is categorized as "Resistant" when there is a high likelihood of therapeutic failure even when there is increased exposure*.

 

*Exposure is a function of how the mode of administration, dose, dosing interval, infusion time, as well as distribution and excretion of the antimicrobial agent will influence the infecting organism at the site of infection.(The European Committee on Antimicrobial Susceptibility Testing. Breakpoint tables for interpretation of MICs and zone diameters. v11.0, 2021. Available at www.eucast.org)

Interpretation
Provides information to assist in interpretation of the test results

A positive result provides definitive evidence of the presence of Helicobacter pylori.

 

Organisms may be detected in asymptomatic (colonized) individuals.

 

False-negative culture results may occur since the organism may die between biopsy collection and laboratory culture.

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

Culture-negative results may occur due to the fastidious nature of the organism. Delays in specimen transportation will decrease recovery of the organism. Culture should be set up as soon as possible following specimen collection. Antimicrobial therapy may render the culture negative.

 

Due to Helicobacter pylori's fastidious nature and slow growth, it may take 7 days to recover the organism and up to an additional 21 days to perform antimicrobial susceptibility testing.

 

When antimicrobial susceptibilities are performed, in vitro 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. The Clinical and Laboratory Standards Institute has defined interpretive categories for clarithromycin. The antimicrobials for which the European Committee on Antimicrobial Susceptibility Testing has defined interpretive categories include amoxicillin, clarithromycin, levofloxacin, metronidazole rifampin, and tetracycline.

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

Theel ES: Helicobacter pylori infection: Test utilization strategies for diagnosis. Mayo Medical Laboratories Communique. 2013;38(6):1-8

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

Method Description
Describes how the test is performed and provides a method-specific reference

The selective Helicobacter pylori media used for isolation has a Brucella agar base with added vancomycin, trimethoprim, polymyxin B, and vitamin K1. Fresh medium and high humidity are essential for organism recovery. Plates are incubated at 35 degrees C in a microaerophilic atmosphere.(Couturier MR: Helicobacter. In: Carroll KC, Pfaller MA, eds. Manual of Clinical Microbiology. 12th ed. ASM Press; 2019:1044-1057)

 

The agar dilution method is used for susceptibility testing. The antimicrobial is added to agar in various concentrations depending upon levels attainable in serum. A standardized suspension of the organism is applied to the agar plates that are incubated for 72 hours at 35 degrees C. Complete inhibition of all but 1 colony or a very fine residual haze represents the endpoint.(Clinical and Laboratory Standards Institute [CLSI]. Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria. 3rd ed. CLSI document M45.CLSI; 2015)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

7 to 28 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87081-Helicobacter pylori culture

87077-Bacteria identification (if appropriate)

87153-Aerobe Ident by Sequencing (if appropriate)

87176-Tissue processing (if appropriate)

87181-Susceptibility per drug and per organism for drugs not in routine battery (if appropriate)

87186-Antimicrobial Susceptibility, Aerobic Bacteria, MIC-per organism for routine battery (if appropriate)

87150-H pylori + Clarithro Resistance PCR (if appropriate)

LOINC® Information

Test Id Test Order Name Order LOINC Value
HELIS Helicobacter pylori Culture + Susc 587-6
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip
HELIS Helicobacter pylori Culture + Susc 587-6

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports