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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:

  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. 

Specimen Stability

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

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.

Reference Range

Negative for Urease production

Day(s) and Time(s) Performed

Daily

Report Available

1-2 days

Method Name

Urease activity detection via pH change in culture media

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

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).