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CLOtest (H. pylori enzyme)
MessageTest performed at York Hospital Laboratory.
Test Code
CLO
CPT Codes
87077
Preferred Specimen
CLOtest device inoculated with a gastric mucosal biopsy specimen
The recommended gastric area to biopsy is at least 2 cm away from the pylorus among the lesser or greater curve of the antrum. Excise tissue that appears normal - avoid tissue that is eroded or ulcerated as H. pylori may be present in smaller numbers around those areas. Additional sample may e inserted into a single CLOtest well. Do not contaminate the second specimen with blood from the first biopsy site.
The recommended gastric area to biopsy is at least 2 cm away from the pylorus among the lesser or greater curve of the antrum. Excise tissue that appears normal - avoid tissue that is eroded or ulcerated as H. pylori may be present in smaller numbers around those areas. Additional sample may e inserted into a single CLOtest well. Do not contaminate the second specimen with blood from the first biopsy site.
Instructions
Obtain CLOtest devices from the laboratory.
1. Remove CLOtest from the refrigerator.
2. Lift the label far enough to expose the yellow gel.
3. With a clean applicator device (e.g. toothpick), push the entire sample beneath the gel surface to expose as much of the specimen to the gel.
4. Re-seal the pressure sensitive label on the device and record the patient name, date, and time of inoculation.
5. Send the properly labeled and inoculated CLOtest device to the laboratory.
1. Remove CLOtest from the refrigerator.
2. Lift the label far enough to expose the yellow gel.
3. With a clean applicator device (e.g. toothpick), push the entire sample beneath the gel surface to expose as much of the specimen to the gel.
4. Re-seal the pressure sensitive label on the device and record the patient name, date, and time of inoculation.
5. Send the properly labeled and inoculated CLOtest device to the laboratory.
Transport Temperature
Room temperature
Specimen Stability
Biopsy specimen must be immersed in the gel within 15 minutes. Store in sterile container until the CLOtest device can be inoculated.
Methodology
Urease indicator gel
Setup Schedule
Daily
Report Available
Next day
Limitations
*The patient should discontinue the use of antibiotics and bismuth preparations three weeks before the biopsy. These agents may suppress but not eradicate the presence of H. pylori making the organism difficult to detect.
*The patient should not have ingested proton pump inhibitors two weeks prior to the test as these drugs have been shown to inhibit growth of the organism in some persons.
*Formalin contamination of the sample may produce a false negative result.
*Late false positive reactions (>12 hours) may be caused by failure to completely insert the biopsy into the gel so that contaminating organisms can grow in the tissue.
*The patient should not have ingested proton pump inhibitors two weeks prior to the test as these drugs have been shown to inhibit growth of the organism in some persons.
*Formalin contamination of the sample may produce a false negative result.
*Late false positive reactions (>12 hours) may be caused by failure to completely insert the biopsy into the gel so that contaminating organisms can grow in the tissue.
Reference Range
Negative
Clinical Significance
Intended for the presumptive diagnosis of H. pylori infection.
