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CLOTest Procedure: Lab Manual for Helicobacter pylori Detection with CLOTest Urease Test, Study notes of Management of Health Service

School of Advanced Study, University of LondonManagement of Health Service

A detailed procedure for performing the clotest urease test to detect helicobacter pylori in gastric mucosal biopsies. The test is intended for the presumptive diagnosis of h. Pylori infection, which is a risk factor for gastritis, gastric cancer, and malt lymphoma. Information on the principle of the test, kit contents and handling procedures, specimen collection, preparation, and precautions, reading and interpretation of results, result reporting, and limitations of the procedure.

What you will learn

  • What are the possible causes for false negative and false positive results in the CLOTest procedure?
  • What precautions should be taken when collecting a gastric biopsy sample for the CLOTest?
  • What is the principle behind the CLOTest urease test for detecting Helicobacter pylori?

Typology: Study notes

2021/2022

Uploaded on 09/27/2022

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Hospital Consolidated Laboratories/Providence Hospital
Hospital Point of Care Manual
CLOTest Procedure Document No: 31.0
Originator: D. Davis Adopted Date: 2/04
Approved by: Dr. Herschman Version No.: 2
Revised by: S. Maisonville Revision Date: 7/30/08
Page 1 of 4
CLOTest ™
NOTE: Associates must test negative for any form of color blindness deficiency before performing
this test.
PRINCIPLE:
The CLOTest rapid urease test (RUT) accurately and conveniently detects the urease enzyme of Helicobacter
pylori in gastric mucosal biopsies. Its use is intended for the presumptive diagnosis of H. pylori infection.
H. pylori has been shown to cause active chronic gastritis and is a risk factor for gastric cancer and mucosal-
associated lymphoid-type (MALT) lymphoma. The eradication of H. pylori is effective in eliminating or reducing
the recurrence of ulcers and may also lower the risk of gastric cancer.
CLOTest is CLIA ’88 waived.
CLOTest is a well of urease indicator gel sealed inside a plastic slide. The gel contains urea, phenol red (a pH
indicator), buffers and a bacteriostatic agent to prevent the growth of contaminating urease-positive organisms.
If the urease from H. pylori is present in the tissue sample, it changes the gel from yellow to bright magenta
according to the following reaction:
NH2
urease
C = O + 2H2O + H+ 2NH4+ + HCO3-
NH
2
Urea water acid ammonium bicarbonate
KIT CONTENTS and HANDLING PROCEDURES:
The CLOTest RUT has a shelf life of 18 months when stored at 2°-8° C (36°– 48° F). The product expires on the
last day of the month indicated on the package. Do not use the product if the gel is not yellow, if the seal is
damaged and the gel appears dehydrated, or if the expiration date has passed.
SPECIMEN COLLECTION, PREPARATION and PRECAUTIONS:
Patient Preparation:
The patient should discontinue the use of antibiotics and bismuth preparations three weeks before the
biopsy. 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.
pf3
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Hospital Consolidated Laboratories/Providence Hospital

Hospital Point of Care Manual

CLOTest Procedure Document No: 31.

Originator: D. Davis Adopted Date: 2/ Approved by: Dr. Herschman Version No.: 2 Revised by: S. Maisonville Revision Date: 7/30/

Page 1 of 4

CLOTest ™ NOTE: Associates must test negative for any form of color blindness deficiency before performingthis test.

PRINCIPLE: The CLOTest rapid urease test (RUT) accurately and conveniently detects the urease enzyme of Helicobacter pylori in gastric mucosal biopsies. Its use is intended for the presumptive diagnosis of H. pylori infection. H. pylori has been shown to cause active chronic gastritis and is a risk factor for gastric cancer and mucosal-associated lymphoid-type (MALT) lymphoma. The eradication of H. pylori is effective in eliminating or reducing the recurrence of ulcers and may also lower the risk of gastric cancer. CLOTest is CLIA ’88 waived. CLOTest is a well of urease indicator gel sealed inside a plastic slide. The gel contains urea, phenol red (a pH indicator), buffers and a bacteriostatic agent to prevent the growth of contaminating urease-positive organisms.If the urease from H. pylori is present in the tissue sample, it changes the gel from yellow to bright magenta according to the following reaction: NH (^2) C = O + 2H urease 2O + H^ +^ 2NH^ 4+^ + HCO^3 - NHUrea (^2) water acid ammonium bicarbonate

KIT CONTENTS and HANDLING PROCEDURES: The CLOTest RUT has a shelf life of 18 months when stored at 2°-8° C (36°– 48° F). The product expires on the last day of the month indicated on the package. Do not use the product if the gel is not yellow, if the seal isdamaged and the gel appears dehydrated, or if the expiration date has passed.

SPECIMEN COLLECTION, PREPARATION and PRECAUTIONS: Patient Preparation: The patient should discontinue the use of antibiotics and bismuth preparations three weeks before the biopsy. The patient should not have ingested proton pump inhibitors two weeks prior to the test as thesedrugs have been shown to inhibit growth of the organism in some persons.

Page 2 of 4 CLOTest Procedure Document No: 31.

The Biopsy:

  1. The recommended gastric area to biopsy is at least 2 cm away from the pylorus along the lesser orgreater 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. A standard biopsy forceps shouldrender a specimen of sufficient size for the test.
  2. An additional sample may be inserted into a single CLOTest well. Do not contaminate the second specimen with blood from the first biopsy site. Procedure:
  3. After removing test slide from refrigeration, lift label on back of CLOTest slide to expose yellow gel (forfaster test results, allow the gel to reach room temperature before inserting the biopsy (approx. 7- minutes).
  4. Using a clean applicator (e.g. toothpick) push entire sample from forceps beneath surface of gel,insuring that specimen is completely submerged.
  5. Reseal and cover with stamped label, including date and time of specimen on label.
  6. Place above specimen in designated area to await reading.
  7. Dispose of specimen in appropriate biohazard container.
  8. Document, complete charge slip appropriately for “CLOTest”.

READING AND INTERPRETATION OF RESULTS: Any change in the color of the whole gel (e.g. red, magenta, pink, deep orange) indicates the presence of H.pylori (a positive result). A positive result should be recorded as soon as noted.

A negative test remains yellow after imbedding the tissue into the gel. If the color of the gel is yellow at 24 hours, the test is negative (see section E below). If unable to be read at 24 hours (e.g. over a weekend) the slide may be stored at room temperature and readany time up to 72 hours.

RESULT REPORTING: Document the following information in logbook located near development area. ƒ Date ƒ ƒ Patient’s nameMR number ƒ ƒ PhysicianSlide lot number ƒ ƒ Slide expiration date (slides have shelf life of 18 months if stored at 36° – 48° F)Test result ƒ ƒ If test result negative – control resultControl lot number and expiration date (controls expire 36 months from date of opening) ƒ ƒ Initials of person reading slideDate read

Page 4 of 4 CLOTest Procedure Document No: 31.

REFERENCES:

CLOTest™ package insert, Kimberly-Clark Corporation, Ballard Medical Products, Draper, Utah 84020 USA. In USA call 1-800-528-5591.