Test Catalog

Test Id : HELIS

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Helicobacter pylori Culture with Antimicrobial Susceptibilities, Varies

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Overview

Test Catalog

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.

 

If an isolate of H pylori does not grow for susceptibility testing, additional testing for H pylori with clarithromycin resistance prediction may be performed.

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.

 

If an isolate of H pylori does not grow for susceptibility testing, additional testing for H pylori with clarithromycin resistance prediction may be performed.

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

For test utilization options, see Helicobacter pylori Diagnostic Algorithm.

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.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
Q00M0011 Specimen Source

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

Preferred:

Specimen Type: Fresh tissue or biopsy

Sources: Gastric

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: Fluid

Sources: Gastric brushings, gastric aspirate

Container/Tube: Sterile container

Specimen Volume: Entire collection or 0.5 mL

 

Specimen Type: Fresh tissue or biopsy

Sources: Duodenum

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

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 Test Request (T728)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

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 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.

 

If an isolate of H pylori does not grow for susceptibility testing, additional testing for H pylori with clarithromycin resistance prediction may be performed.

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 younger than 60 years old without alarming signs and symptoms (see Helicobacter pylori Diagnostic Algorithm). 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 60 years old or older 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 of Helicobacter pylori

 

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; therefore, the following comment will be included on the report: There are no established interpretive guidelines for agents reported without interpretations.

 

For information regarding CLSI and EUCAST susceptibility interpretations, see Susceptibility Interpretative Category Definitions.

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

Chen D, Cunningham SA, Cole NC, Kohner PC, Mandrekar JN, Patel R: Phenotypic and molecular antimicrobial susceptibility of Helicobacter pylori. Antimicrob Agents Chemother. 2017;61(4):e02530-16

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 account representative. 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
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
HELIS Helicobacter pylori Culture + Susc 587-6
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
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