H pylori w Clarithro Resist PCR, Stool (Sendout)

General Information

Lab Name
H pylori w Clarithro Resist PCR, Stool (Sendout)
Lab Code
RHPFRP
Epic Name
H pylori w Clarithro Resist PCR, Stool (Sendout)
External Test Id
HPFRP
Description

Useful For: Aiding in the diagnosis of Helicobacter pylori infection and prediction of clarithromycin resistance or susceptibility directly from stool. This test detects the Helicobacter pylori 23S ribosomal RNA gene and the 3 most common 23S ribosomal RNA gene single nucleotide variations (A2143G, A2142G, and A2142C) that lead to resistance to clarithromycin.

Synonyms
H pylori, H. pylori feces, H. pylori stool, Helicobacter pylori PCR, Helicobacter pylori with Clarithromycin resistance prediction, HPFRP, T058
Components

Interpretation

Method

Real-Time Polymerase Chain Reaction (PCR)

Reference Range
See individual components
Interferences and Limitations

Cautions:

Avoidance of bismuth compounds, antibiotics, and acid suppressive drugs (histamine H2-receptor antagonists and proton pump inhibitors) should occur for at least 2 weeks before the test, as these medications may lead to a false-negative test result due to potential activity against Helicobacter pylori.

Test results should be used as an aid in the diagnosis. The single assay should not be used as the only criterion to form a treatment decision; results of this test should be correlated with clinical presentation and results of other laboratory tests. A negative result does not negate the presence of the organism or active disease.

Potential cross-reactivity may occur with the following nonpylori Helicobacter species: Helicobacter acinonychis, Helicobacter cetorum, and Helicobacter mustalae (not been reported to cause disease in humans) and Helicobacter canis, Helicobacter cinaedi, Helicobacter bizzozeronii, and Helicobacter heilmannii (infrequently found in humans).

This assay examines the three most common 23S ribosomal RNA single point variants associated with clarithromycin resistance. Other mechanisms of clarithromycin resistance are not assessed, nor are mechanisms of resistance to non-clarithromycin antimicrobial agents.

Ordering & Collection

Specimen Type
Stool
Collection

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

Patient Preparation: Proton pump inhibitors, histamine H2-receptor antagonists and other antacids, as well as antibiotics and bismuth compounds, should be discontinued at least 2 weeks prior to testing.

Collection Instructions:

  • Collect fresh fecal specimen and submit 1 gram or 5 mL in container with transport medium (see acceptable types below).
  • Acceptable Collection Containers:
    • Mayo C&S Vial (T058)
    • 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&S (Culture and Sensitivity)
  • Place feces in preservative within 2 hours of collection.

FHCC Collection Sites: Use orange-cap ParaPak C&S (culture and sensitivity) stool transport container with modified Cary-Blair medium/Phenol Red indicator.

Unacceptable Collections:

  • Fecal swab
  • ESwab transport medium
  • Feces in gel transport medium
  • ECOFIX preservative
  • formalin PVA fixative
  • Unpreserved stool (>2 hours after collection)
  • Frozen stool
Handling Instructions

Outside Laboratories: Transfer stool to acceptable preservative within 2 hours of collection. Refrigerate specimen.

Stability: Refrigerated: 7 days; Ambient: 7 days; Frozen: Unacceptable.

Reject Due To: Fecal swab, ESwab transport medium, Feces in gel transport medium, ECOFIX preservative, formalin PVA fixative, Unpreserved stool, Frozen stool.

Quantity
Requested: 5 mL stool
Minimum: 1 mL stool

Processing

Receiving Instructions

Refrigerate specimen.

  • If unpreserved stool is received, it can be transferred to an acceptable preservative container within 2 hours of collection.

Sendouts:

  • Order Mayo test: HPFRP
  • Interfaced: Yes [Interface: 601; Worksheet: MARF]

Stability: Refrigerated: 7 days; Ambient: 7 days; Frozen: Unacceptable.

Reject Due To: Fecal swab, ESwab transport medium, Feces in gel transport medium, ECOFIX preservative, formalin PVA fixative, Unpreserved stool, Frozen stool.

Misc Sendout

Performance

Lab Department
Sendouts Mayo Lab (RF)(MARF)
Frequency
Performed: Monday - Friday. Report Available: 3-4 days.
Available STAT?
No
Performing Location(s)
Sendout Mayo Clinic Laboratories
800-533-1710

200 First Street Southwest
Rochester, MN 55901

Billing & Coding

CPT Codes
87513
LOINC
30896-5
Interfaced Order Code
UOW4505