Avent, Inc.

Avent, Inc. Drugs

• Pytest
  

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  Pytest

  

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  Materials provided

  As shown in Figure 2, the PYtest1 Kit contains:

  PYtest1 capsule Two 30 mL disposable cups One drinking straw One mylar collection balloon One report form One mailing box with labels2

  Figure 2: PYtest1 Kit

  2 The kit includes analysis by Kimberly-Clark of one balloon from one patient at one time point.

  Materials Needed but not Provided

  Stopwatch/Timer capable of timing an interval up to 10 minutes. Water (40mL)

  Dosage

  One PYtest1 capsule.

  Procedural Notes

  Inform the patient to fast for 6 hours prior to the test. The patient should be off antibiotics and bismuth for 1 month, and proton pump inhibitors and sucralfate for 2 weeks prior to the test. Have patient sitting at rest while doing the test. The capsule should not be handled directly as this may interfere with the test result. To avoid contamination by bacteria in the mouth, the capsule should be swallowed intact. Do not chew capsule.

  Step by Step Procedure for Balloon

  Table 3: Breath Sample Collection by Balloon Before the test Label balloon and fill in breath test report form. Check that all materials are present. Minus 1 Open the package containing the 14C-urea capsule minute and tip the capsule into the empty 30 mL cup. Do not handle the capsule directly. Hand the cup to the patient. Fill the second cup with 20 mL lukewarm water. 0 minute Ask the patient to tip the capsule directly into his/her mouth, then swallow it with the 20 mL of lukewarm water. Start the stopwatch when the patient swallows the capsule. Discard waste (e.g., capsule packaging, used straws) according to your facility's regulations. 3 minutes Ask the patient to drink another 20 mL of lukewarm water (in case the capsule may have lodged in the esophagus and not yet reached the gastric mucosa). 10 minutes Push a drinking straw into the neck of the balloon. Ask the patient to hold his/her breath for 5-10 seconds, then blow up a balloon with a slow breath through the straw, filling the balloon completely. Tie the neck of the balloon into a tight knot. Check that the balloon label and the breath test report form are completed correctly. After the test Place the filled balloon and breath test report in the box and forward to Kimberly-Clark for analysis.

  Quality Control

  A minimum of 1 mM of CO2 is required to perform analysis of a breath sample. The amount of breath required to provide 1 mM of CO2 varies depending on the amount of CO2 the patient is producing. Since a full balloon typically contains at least 1 mM of CO2, the balloon should be completely filled.

  Results

  Interpretation of results (10 minute sample)      <50 DPM Negative for H.pylori      50-199 DPM Indeterminate for H.pylori      ≥200 DPM Positive for H.pylori

  The indeterminate result should be evaluated by repeating the PYtest1 or using an alternative diagnostic method. If repeat breath testing is undertaken, careful history to exclude confounding factors should be obtained. If confounding factors are present, wait an appropriate time (refer to Table 4) before repeating the PYtest1.

  The cutoff point of 50 DPM was determined to be the mean + 3SD of results obtained in patients who did not have H.pylori.

  DPM = Disintegrations per minute

  Table 4: Factors which might cause sub-optimal breath test results Factor Result Comment Recent antibiotic or bismuth (Pepto-Bismol, etc.) false neg. Relapse of partially treated Hp may take 1-4 weeks. Omeprazole (or other proton pump inhibitors) false neg. These agents suppress Hp in 40% of patients. Discontinue for at least 2 weeks before performing the PYtest1. Resective gastric surgery false neg. Isotope may empty rapidly from the stomach. Resective gastric surgery false pos. Patient may be achlorhydric and have bacterial overgrowth (non-Hp urease). Food in stomach (also bezoar, gastroparesis) unknown Isotope may not come into contact with gastric mucosa. Patient may be achlorhydric and/or have bacterial overgrowth (non-Hp urease).

  Expected Values

  As shown in Figure 3 approximately 30% of patients tested will be positive for H.pylori.

  Figure 3: Histogram showing DPM distribution for the PYtest1.

  Note: DPM groupings were calculated on a logarithmic scale. Empty DPM groupings were not included. Chart includes all patients from Studies 1 and 2.

  Frequency of DPM group includes samples with DPM < Group Name.

       DPM = Disintegrations per minute

       Gold Standard = Agreement between histology and CLOtest1

  If the capsule is damaged or appears abnormal in any way, it may give inaccurate results.

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• Pytest
  

  ×

  Pytest

  

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  Materials Needed but not Provided

  FOR ANALYSIS AT TEST SITE BREATH SAMPLE COLLECTED INTO BALLOON (RECOMMENDED METHOD; SEE FIGURE 2)

  Breath test report form Stopwatch/Timer capable of timing an interval up to 10 minutes Marking pen 1 – 20 ml scintillation vial Breath transfer pump Pipette (10 ml) for measuring fluids Collection fluid (2.5 ml/vial) Scintillation fluid (10 ml/vial) 1 – Mylar collection balloon 1 – Straw 2 – Needles 2 – 30 ml medicine cups Water (40 ml) Any gas pump that is airtight and has a flow rate between .5 and 1 liter per minute may be used.

  Figure 2: Other Components

  FOR ANALYSIS ON SITE BREATH SAMPLE COLLECTED INTO VIAL

  CAUTION: Kimberly-Clark does not endorse breath sample collection by this method because patients might come into direct contact with the hyamine.

  Breath test report form Stopwatch/Timer capable of timing an interval up to 10 minutes Safety trap (Figure 3) 1 – Straw 1 – 20 ml scintillation vial Marking pen Pipette (10 ml) for measuring fluids Collection fluid (2.5 ml/vial) Scintillation fluid (10 ml/vial)

  Figure 3: Typical Safety Trap

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