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HelpTest Code HPRP Helicobacter pylori with Clarithromycin Resistance Prediction, Molecular Detection, PCR, Tissue
Ordering Guidance
If testing directly from feces is desired, order HPFRP / Helicobacter pylori with Clarithromycin Resistance Prediction, Molecular Detection, PCR, Feces.
For more information see Helicobacter pylori Diagnostic Algorithm.
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.
Submit only 1 of the following specimens:
Specimen Type: Fresh tissue or biopsy
Sources: Stomach (or duodenum)
Container/Tube: Sterile container
Specimen Volume: Entire collection or 5 mm (3) approximate size of a pencil eraser
Collection Instructions:
1. Collect fresh tissue specimen.
2. Submit tissue in a sterile container (without adding anything).
3. Refrigerate or freeze the specimen.
Specimen Stability Information: Refrigerated (preferred) 7 days/Frozen 7 days
Preferred:
Supplies: Tissue Block Container (T553)
Specimen Type: Formalin-fixed, paraffin-embedded (FFPE) tissue block
Sources: Stomach (or duodenum)
Container/Tube: Tissue block
Collection Instructions: Submit FFPE tissue block to be cut and returned.
Specimen Stability Information: Ambient (preferred)/Refrigerated
Acceptable:
Specimen Type: Formalin-fixed, paraffin-embedded (FFPE) tissue scroll
Sources: Stomach (or duodenum)
Container/Tube: Sterile container for each individual cut section (scroll)
Collection Instructions: Perform microtomy and prepare five separate 10-micron sections. Each section (scroll) must be placed in a separate sterile container for submission.
Specimen Stability Information: Ambient (preferred)/Refrigerated
Useful For
Aiding in the diagnosis of Helicobacter pylori infection and prediction of clarithromycin resistance or susceptibility directly from gastric biopsies
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| TISSR | Tissue Processing | No | No |
Testing Algorithm
When this test is ordered, the reflex test may be performed at an additional charge.
For more information see Helicobacter pylori Diagnostic Algorithm.
Special Instructions
Method Name
Real-Time Polymerase Chain Reaction (PCR)
Reporting Name
H pylori + Clarithro Resist, PCRSpecimen Type
VariesSpecimen Minimum Volume
Fresh tissue or biopsy: 5 mm(3)
Formalin-fixed paraffin-embedded tissue block: One block
Formalin-fixed paraffin-embedded tissue scroll: Two 10-micron sections
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Varies | ||
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 three most common 23S ribosomal RNA gene mutations (A2143G, A2142G/C) 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):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
Day(s) Performed
Monday through Friday
Report Available
4 to 6 daysPerforming 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 |
|---|---|---|
| HPRP | H pylori + Clarithro Resist, PCR | 88509-5 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| HPS3 | Specimen Source | 31208-2 |
| 616027 | Helicobacter pylori Result | 91060-4 |
| 616028 | Clarithromycin Resistance Result | 88509-5 |
Forms
If not ordering electronically, complete, print, and send Gastroenterology and Hepatology Test Request (T728) with the specimen.