Helicobacter pylori  Culture, Rapid Urease (CLO Test)

Test Code
CXHPY


Alias/See Also
Epic: LAB12828


Preferred Specimen
Specimen Type: Gastric
Submission Container: CLOTest Cartridge


Instructions
  1. After removing the CLOtest rapid urease test slide from refrigeration, lift the label far enough to expose the yellow gel. For faster test results, allow the gel to reach room temperature before inserting the biopsy (usually between 7–10 minutes).
  2. With a clean applicator device (e.g., toothpick etc.) push the entire sample from the forceps beneath the surface of the gel to expose as much of the specimen to the gel as possible. Make sure that the biopsy specimen is completely immersed in the gel.
  3. Re-seal the pressure-sensitive label on the slide and record the patient information as well as the time the biopsy sample was inserted.
  4. Submit the CLOTest to the laboratory. The CLOtest may be transported at room temperature and must reach the laboratory within 24 hours of collection. 


Transport Container
CLOTest Cartridge


Specimen Stability

Room temperature: 72 hours (after insertion of biopsy into the CLOTest cartridge gel medium)




Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Rejection will occur for the following reasons: improperly labeled specimen, insufficient volume, specimen not submitted in appropriate transport container, samples not received in CLOTest device


Methodology

Urease activity detection via pH change in culture media



Setup Schedule

Daily




Report Available

1-2 days




Limitations

A false negative reaction could result from a biopsy containing an insufficient number of organisms, a sample of intestinal metaplasia, recent ingestion of antibiotics, bismuth, proton pump inhibitors, or sucralfate, formalin contamination of the sample. False positives may be caused by failure to completely insert the biopsy into the gel (and growth of contaminating organisms).




Reference Range
Negative for Urease production


Clinical Significance
This assay is for detection of the urease enzyme produced by H. pylori. Rarely, there may be other urease positive organisms in gastric specimens. Clinical correlation is advised.


Performing Laboratory
Inova Laboratories
2832 Juniper Street
Fairfax, VA 22031



Last Updated: February 20, 2023
Last Review: N. Wolford, February 20, 2023


The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.