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Test Code HPCRP Helicobacter pylori with Clarithromycin Resistance Prediction, Molecular Detection, PCR, Varies

Infectious


Ordering Guidance


This test uses isolates of Helicobacter pylori for testing. If testing directly from feces is desired, order HPFRP / Helicobacter pylori with Clarithromycin Resistance Prediction, Molecular Detection, PCR, Varies.



Additional Testing Requirements


1. If identification testing is needed; also order IDENT / Organism Referred for Identification, Aerobic Bacteria.

2. If susceptibility testing is needed; also order ZMMLS / Antimicrobial Susceptibility, Aerobic Bacteria, MIC, Varies.



Shipping Instructions


1. For shipping information see Infectious Specimen Shipping Guidelines.

2. Place specimen in a large infectious container and label as an etiologic agent/infectious substance, if appropriate.



Necessary Information


Organism identification and specimen source are required.



Specimen Required


Supplies: Infectious Container, Large (T146)

Container/Tube: Agar slant or other appropriate media

Specimen Volume: Isolate

Collection Instructions:

1. Perform isolation of Helicobacter pylori in culture.

2. H pylori isolate must be submitted in pure culture. Do not submit mixed cultures.


Useful For

Assessing pure isolates of Helicobacter pylori to predict clarithromycin resistance or susceptibility

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
PCRID Identification by PCR No, (Bill Only) 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.

Reporting Name

H pylori + Clarithro Resist PCR

Specimen Type

Varies

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Ambient (preferred)
  Frozen 
  Refrigerated 

Reject Due To

Agar plate
ESwab
Port-a-Cult
Reject

Reference Values

Not applicable

Supportive Data

During laboratory verification studies, 111 isolates of Helicobacter pylori (grown on Columbia agar with 5% sheep blood) with previous clarithromycin phenotypic susceptibility testing performed and which had undergone partial 23S ribosomal RNA gene sequencing were studied. This test matched phenotypic testing for 106/111 isolates (95.5% categorical agreement); a major error rate of 8.7% (2/23) and very major error rate of 3.4% (3/88) were observed. The assay results perfectly matched partial 23S ribosomal RNA gene sequencing data, including that performed on the 5 discordant isolates.

 

A subset of 45 of the isolates (including 1/5 isolates demonstrating a discordant result in the earlier study) were re-grown on tryptic soy agar with 5% sheep blood and re-assayed with this assay. The assay matched phenotypic testing in 44/45 isolates (97.8% categorical agreement); a major error rate of 0% and very major error rate of 3% (1/33) were observed. The polymerase chain reaction assay perfectly matched partial 23S ribosomal RNA gene sequencing data, including that performed on the single discordant isolates.

Day(s) Performed

Monday through Friday

Report Available

3 to 4 days

Specimen Retention Time

30 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87150

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HPCRP H pylori + Clarithro Resist PCR 88509-5

 

Result ID Test Result Name Result LOINC Value
HPS2 Specimen Source 31208-2
HPORG Organism Identified by Client In Process
608005 Helicobacter pylori Result 49101-9
608006 Clarithromycin Resistance Result 88509-5

Forms

If not ordering electronically, complete, print, and send Gastroenterology and Hepatology Test Request (T728) with the specimen