Test Code CXHPY Helicobacter pylori Culture, Rapid Urease (CLO Test)
Additional Codes
Epic: LAB12828
Specimen Required
Patient Preparation:
Collection Container/Tube: Gastric Biopsy submitted in
CLOTest Cartridge
Submission Container/Tube: CLOTest Cartridge
Collection Instructions:
- 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).
- 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.
- Re-seal the pressure-sensitive label on the slide and record the patient information as well as the time the biopsy sample was inserted.
- Submit the CLOTest to the laboratory. The CLOtest may be transported at room temperature and must reach the laboratory within 24 hours of collection.
Specimen Stability
Room temperature: 72 hours after insertion of the biopsy into the CLOTest cartridge gel medium.
Reference Range
Negative for Urease production
Report Available
1-2 days
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.
Method Name
Urease activity detection via pH change in culture media
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).
Reject Due To
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
Day(s) Performed
Daily