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PY TEST CAPSULES & PY TEST KIT [SIN13330P]

Active ingredients: PY TEST CAPSULES & PY TEST KIT

Last updated 26 October 2025

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Product Info
RESULTS

Product Info

PY TEST CAPSULES & PY TEST KIT

[SIN13330P]

Product information

Active Ingredient and Strength

14-C UREA - 37 (+/-20%) KβQ (1 MCG +/-20%)

Dosage Form

CAPSULE

Manufacturer and Country

AVENT, INC. (A WHOLLY SUBSIDIARY OF AVANOS MEDICAL, INC.) - UNITED STATES

Registration Number

SIN13330P

Licence Holder

ALL EIGHTS (SINGAPORE) PRIVATE LIMITED

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

NA

Indications and Usage

PYTest® (urea[14C] breath test) is indicated for use in the detection of gastric urease as an aid in the diagnosis of H.pylori infection in the human stomach.

Dosage and Administration

Materials provided:

As shown in Figure 3, the PYtest® Kit contains:

  • PYtest® capsule

  • Two 30 mL disposable cups

  • One drinking straw

  • One Pioneer brand biax balloon

  • One report form

  • One mailing box with labels**
    ** The kit includes analysis by TRI-MED Distributors, Pty Ltd of one balloon from one patient at one time point.

PYtest Dosage Figure 3



Materials Needed but not Provided:

  1. Stopwatch/Timer capable of timing an interval up to 10 minutes.

  2. Water (40mL)

Dosage:

One PYtest® capsule.

Procedural Notes:

  • Inform the patient to fast for 4 hours prior to the test.

  • The patient should not have taken antibiotics and bismuth containing products for 1 month, proton pump inhibitors for 1 week and sucralfate for 2 week 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:

PYtest Dosage Table 4



Precautions for Use

Because of the very low radioactivity of individual PYtest® capsules, no special precautions are needed for the disposal of small numbers of capsules. Where it is necessary to dispose large quantities of capsules, the disposal of the waste should be carried out in accordance with the NHMRC Code of Practice for the Disposal of Radioactive Waste by Users, (1985).

Quality Control

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

RESULTS

Interpretation of results (10 minute sample)

Table caption

<50 DPM

Negative for H.pylori

50–199 DPM

Borderline Positive for H.pylori

>200 DPM

Positive for H.pylori

(DPM = disintegrations per minute)

The indeterminate result should be evaluated by repeating the PYtest® 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 5) before repeating the PYtest®. The cutoff point of 50 DPM was determined to be the mean + 3SD of results obtained in-patients who did not have H.pylori.

PYtest Dosage Table 5