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Test Code HPFRP Helicobacter pylori with Clarithromycin Resistance Prediction, Molecular Detection, PCR, Feces


Ordering Guidance


Confirmation of eradication testing should not be ordered until 4 or more weeks after cessation of treatment.



Specimen Required


The high sensitivity of amplification by polymerase chain reaction requires the specimen to be processed in an environment in which contamination of the specimen by Helicobacter pylori DNA is unlikely.

 

Patient Preparation:

1. For 4 weeks prior to testing, patient should not take antibiotics.

2. For 2 weeks prior to testing, patient should not take proton pump inhibitors or bismuth compounds.

Supplies: Culture and Sensitivity Stool Transport Vial (T058)

Specimen Type: Preserved feces

Submission Container/Tube: Commercially available transport system specific for recovery of enteric pathogens from fecal specimens (15 mL of nonnutritive transport medium containing phenol red as a pH indicator, either Cary-Blair or Para-Pak C and S)

Specimen Volume: 5 mL

Collection Instructions:

1. Collect fresh fecal specimen and submit 1 gram or 5 mL in container with transport medium.

2. Place feces in preservative within 2 hours of collection.

3. Place vial in a sealed plastic bag and send ambient or refrigerated. Specimens sent frozen will be rejected.


Useful For

Aiding in the diagnosis of Helicobacter pylori infection and prediction of clarithromycin resistance or susceptibility directly from stool

Testing Algorithm

For more information see Helicobacter pylori Diagnostic Algorithm.

Method Name

Real-Time Polymerase Chain Reaction (PCR)

Reporting Name

H pylori + Clarithro Resist, PCR, F

Specimen Type

Fecal

Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Fecal Ambient (preferred) 7 days
  Refrigerated  7 days

Reference Values

Not detected

Interpretation

A detected result indicates the presence of Helicobacter pylori 23S ribosomal RNA gene; also indicated is whether or not one the 3 most common 23S ribosomal RNA gene single nucleotide variations (A2143G, A2142G, and A2142C) associated with clarithromycin resistance is detected.

 

A not detected result for H pylori indicates the absence of detectable H pylori DNA but does not negate the presence of the organism and may occur due to inhibition of the polymerase chain reaction (PCR), sequence variability underlying primers or probes, or the presence of H pylori DNA in quantities less than the limit of detection of the assay.

Clinical Reference

1. Malfertheiner P, Megraud F, O'Morain CA, et al. Management of Helicobacter pylori infection--the Maastricht IV/Florence Consensus Report. Gut. 2012;61(5):646-664. doi:10.1136/gutjnl-2012-302084

2. Chen D, Cunningham SA, Cole N, Kohner PC, Mandrekar JN, Patel R. Phenotypic and molecular antimicrobial susceptibility of Helicobacter pylori. Antimicrob Agents Chemother. 2017;61(4):e02530-16. doi:10.1128/AAC.02530-16

3. Beckman E, Saracino I, Fiorini G, et al. A novel stool PCR test for Helicobacter pylori may predict Clarithromycin resistance and eradication of infection at a high rate. J Clin Microbiol. 2017;55(8):2400-2405

4. Marrero Rolon R, Cunningham SA, Mandrekar JN, Polo ET, Patel R. Clinical evaluation of a real-time PCR assay for simultaneous detection of helicobacter pylori and genotypic markers of clarithromycin resistance directly from stool. J Clin Microbiol. 2021;59(5):e03040-20. doi:10.1128/JCM.03040-20

5. Savarino V, Tracci D, Dulbecco P, et al. Negative effect of ranitidine on the results of urea breath test for the diagnosis of Helicobacter pylori. AM J Gastroenterol. 2001;96(2):348-52. doi:10.1111/j.1572-0241.2001.03517.x

6. Chey WD, Grigorios L, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori infection. Am J Gastroenterol. 2017;112(2):p 212-239. doi:10.1038/ajg.2016.563

7. Jones NL, Koletzko S, Goodman K, et al. Joint ESPGHAN/NASPGHAN Guidelines for the Management of Helicobacter pylori in Children and Adolescents. J Pediatr Gastroenterol Nutr. 2017:64(6):p 991-1003. doi:10.1097/MPG.0000000000001594

8. Malfertheiner P, Megraud F, O'Morain CA, et al. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017;66(1):6-30. doi:10.1136/gutjnl-2016-312288

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

87798

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HPFRP H pylori + Clarithro Resist, PCR, F 88509-5

 

Result ID Test Result Name Result LOINC Value
HPSRC Specimen Source 31208-2
608002 Helicobacter pylori Result 91061-2
608003 Clarithromycin Resistance Result 88509-5

Day(s) Performed

Monday, Wednesday, Friday

Report Available

4 to 6 days

Forms

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

1. Microbiology Test Request (T244)

2. Gastroenterology and Hepatology Test Request (T728)