Note: for in vitro diagnostic use only.
Accutest H. pylori Urease Test is CLIA WAIVED
Facilities performing testing must have a CLIA Certificate of W aiver. 42 USA 263a(c)(2). Any laboratory eligible for
a Certificate of Waiver must follow the test system instruct ions, including use with only the waived specimen type,
instructions for limitations/intended use, and performance of QC testing as a fai lure-alert mechanism. (42 CFR
493.15(e).) Any modification to the test or the manufacturer’s instructions will result in the test being classi fied as
highly complex.
Treat all biopsy specimens as if capable of transmitting disease. Caution should be used in handling and
disposing of these specimens at bio-safety level 2 as recommended in the Centers for Disease Control /National
Institute of Health Manual, Bio-safety in Microbiological and Biomedical Laboratories, 1984. Your laboratory safety
procedures should also be followed as well as any other local or state health recommendations.
INTENDED USE: Accutest H. pylori Urease Test is intended for the qualitative detection of the urease enzyme in
gastric mucosal biopsy specimens for the presumptive determination of Helicobacter pylori in symptomatic adult
patients. SUMMARY / BIOLOGICAL PRINCIPLE: Helicobacter pylori has been shown to cause active chronic
gastritis and has been implicated as a primary etiologic factor in duodenal ulcer disease, gastric ulcer and non
ulcer dyspepsia1. By causing chronic inflammation Helicobacter pylori may weaken the mucosal defenses and
allow acid and pepsin to disrupt the epithelium.
H.pylori produces large amounts of urease enzyme2. Although urease primarily allows H. pylori to utilize urea as a
nitrogen source, the breakdown of urea also produces high local concentrations of ammonia, which enable the
organism to tolerate low pH (see reaction below).
urease
(NH2)CO + 2H20 + H+ ------> 2NH4+ + HCO3-
urea ammonium bicarbonate
ion ion
Although H.pylori can be detected with histology or culture of gastric tissue, simple tests for the presence of
urease enable more rapid and convenient diagnosis. Tests for gastric urease are specific for H.pylori because
mammalian cells do not produce urease and very few micro-organisms survive in the stomach, except for H.
pylori.
WARNING: POTENTIAL BIOHAZARDOUS MATERIAL
Note: for in vitro diagnostic use only.
Treat all biopsy specimens as if capable of transmitting disease. Caution should be used in handling and
disposing of these specimens at bio-safety level 2 as recommended in the Centers for Disease Control/National
Institute of Health Manual, Bio-safety in Microbiological and Biomedical Laboratories, 1984. Your laboratory safety
procedures should also be followed as well as any other local or state health recommendations.
STORAGE: Accutest H. pylori Urease Test should be stored at room temperature away from direct light. Accutest
H. pylori Urease Test has a shelf life of 24 months.
Before use, each Accutest H. pylori Urease Test slide should be inspected to make s ure the test surface is yellow.
If the test surface is red or magenta the slide should not be used.
SPECIMEN COLLECTION AND HANDLING
Preparation of the patient: Patients should not have taken antibiotics or bismuth salts for at least three weeks
prior to endoscopy. Suppression of H. pylori by these agents makes the organism difficult to detect by any means,
and re-growth of H. pylori may be patchy, leading to false negative results in the first few weeks after treatment.
Taking and Inserting the Biopsy:
1. A biopsy specimen for Accutest H. pylori Urease Test may be taken as soon as the endoscopist has examined
the stomach. The usual area to biopsy is the sump of the antrum, along the greater curve.
2. Biopsy an area of normal-looking tissue rather than an area affected by erosions or ulceration. This is because
H.pylori may be present in smaller numbers if the epithelium is eroded or the mucous layer is denuded. The
standard biopsy forceps will provide a specimen of sufficient size (2 - 3 mm diameter).
3. If the biopsy specimen appears to be very small, it may be worthwhile taking a second biopsy and inserting both
specimens into the Accutest H. pylori Urease Test. Be careful not to contaminate the second specim en with blood
from the first biopsy site.
ACCUTEST H. PYLORI UREASE TEST PROCEDURE
1. Peel back the label of the Accutest H. pylori Urease Test thus exposing the reactive yellow pad.
2. Immediately after peeling back the label, using a sterile blunt instrument, remove the specimen from the biopsy
forceps and place it onto the reactive yellow pad. Make certain that the tissue is positioned to have maximum
contact with the reactive pad.
3. Re-seal the test. Press the label over the reactive pad lightly with your finger to squeeze the tissue contents out
of the specimens. On the label, record the name of the patient, the date and the time the specim en was inserted.
4. Accurate resealing is important to prevent the biopsy specimens from drying up.
RESULTS: Reading the Accutest H. pylori Urease Test:
1. We recommend examining the Accutest H. pylori Urease Test at intervals of 5 minutes, 30 minutes and one
hour. If any of those intervals or any time in between reveal a positive result the test is positive. Usually the first
attempt to read the Accutest H. pylori Urease Test is made after the endoscopy report has been completed. This
allows the endoscopist to objectively report the endoscopic findings before being aware of the presence of H.
pylori.
2. If H. pylori are present in the tissue, an expanding red color zone will be noted around the biopsy specimen, or
the Accutest H. pylori Urease Test will gradually change to a deep orange, then red color. A red reactive pad
anytime within an hour is a positive reaction.
3. A negative result is when the Accutest H. pylori Urease Test reactive pad is still yellow 1 hour after insertion of
the specimen.
MATERIALS PROVIDED: Accutest H. pylori Urease Test is packaged in boxes of 50 test slides with an
instruction sheet.
MATERIALS REQUIRED BUT NOT INCLUDED WITH THE TEST: Not supplied with the Accutest H. pylori
Urease tests are the biopsy forceps for collecting the specimens or the blunt instrument for transferring the
specimen to the test.
QUALITY CONTROL: We recommend a positive external control must be preformed when opening a new test
kit. The test kit size must not exceed 50. Accutest H. pylori Urease Test controls come in two forms: Dry Paper
Dot Control and Liquid Control. Either may be used.
If the Accutest H. pylori Urease Test is negative after 1 hour and there is a question if the test has functioned
properly, perform the following positive control test:
LIQUID CONTROL
1. Peel back the label on the Accutest H. pylori Urease Test so that the yellow ring is visible.
2. Place 1 small drop of control solution directly on the testing surface. The control solution gives a positive res ult.
3. Reseal the Accutest H. pylori Urease Test.
4. Observe the ring for a positive color change to magenta. The color change should occur within 30 seconds but
may take up to 1 hour. Please Note: In some cases you may notice the center of the test changing to magenta
before the outer ring. This is NORMAL and caused by the introduction of liquid onto the filter paper. Any change in
color from yellow to magenta on any part of the test surface should be considered POSITIVE.
5. If after 1 hour there is no change in the color, please contact Jant Pharmacal Corporation Customer Service at
800-676-5565.
DRY PAPER DOT CONTROL
1. Peel back the label on the Accutest H. pylori Urease Test so that the yellow ring is visible.
2. Place 1 - 2 ‘Accutest H. pylori Urease Test ‘Positive Control Dots on the ring with one drop of distilled water.
The Control Dot gives a positive result.
3. Reseal the Accutest H. pylori Urease Test.
4. Observe the ring for a positive color change to magenta. The color change should occur in about 5 minutes but
may take up to 1 hour. Please Note: In some cases you may notice the center of the test changing to magenta
before the outer ring. This is NORMAL and caused by the introduction of liquid onto the filter paper. Any change in
color from yellow to magenta on any part of the test surface should be considered POSITIVE.
5. If after 1 hour there is no change in the color, the test is Invalid. Please contact Jant Pharmacal Corporation
Customer Service at 800-676-5565.
LIMITATIONS: False negative Accutest H. pylori Urease Test results may occur when very low numbers of H.
pylori are present or the bacterium has a patchy distribution. For example, in 1-5% of patients the bacterium is
present in the body of the stomach but not in the antrum, or vice versa. In patients with widespread intestinal
metaplasia, an area of intestinal epithelium may be biopsied. As H. pylori does not colonize intestinal mucosa, a
false negative Accutest H. pylori Urease Test can result. To reduce the occurrence of false negatives, two
Accutest H. pylori Urease tests should be performed, one with a sample from the antrum and one from the body of
the stomach.
All tests for H.pylori, inc luding Accutest H. pylori Urease Test, will be less sensitive if the patient has recently
taken antibiotics or bismuth. Re-growth of H.pylori may be patchy after suppression with antibiotic. Again, an extra
biopsy may be taken for Accutest H. pylori Urease Test to avoid a false negative reading.
False positive Accutest H. pylori Urease Test results are rare. Theoretically, false positive Accutest H. pylori
Urease Test results could occur in patients who have achlorhydria (for example patients with pernicious anemia,
previous gastric surgery, or who have recently taken antacid or large doses of H2 receptor antagonists). W hen
acid is absent, commensal organisms such as Proteus spp. may grow in the stomach and produce urease. False
Accutest H. pylori Urease Test
Product Insert
