Product Information:

®
PYtest
AUST R 67146

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The urea breath test kit

for detecting

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Helicobacter pylori
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ACN 080 507 277

Phone: +61 8 9388 1444

Free Call Number: 1800 08 05 07
Facsimile: +61 8 9388 1744
Email: info@[Link]
[Link]

*VYWVYH[L6MÄJL!:V\[OWVY[:[YLL[>LZ[3LLKLY]PSSL>LZ[LYU(\Z[YHSPH
Corporate Office: 105 Hay St., Subiaco, Western Australia, 6008
Postal Address: Locked Bag 15, Subiaco, Western Australia, 6904
  KIT (UREA[14C] BREATH TEST)
PYTEST histological analysis (2 samples, Giemsa stain) and rapid urease test (1
sample, CLOtest). Breath samples were mailed to a laboratory where they
Description were read in a liquid scintillation counter. Results were reported as
disintegrations per minute (DPM). Analysis for accuracy used the ten
PYtest (urea[14C] breath test) is a qualitative and non-invasive method for minute breath sample. A breath sample DPM <50 was defined as a
the diagnosis of Helicobacter pylori ([Link]). To detect [Link], urea[14C] negative result. DPM *200
>200 was * defined as a positive result. DPM in the
supplied in a capsule is swallowed by the patient. If gastric urease from range of 50 -199 was classified as indeterminate.
[Link] is present, urea is split to form CO2 and NH3 . Ten minutes after the STUDY 1:
patient ingests the capsule a breath sample is collected into a balloon. The Of 186 patients who had histopathology and Campylobacter Like Organism
breath sample is later transferred to collection fluid to trap the labelled CO2. [(CLO)test] (80 men, 106 women), 53 were infected with [Link] as
The liquid sample is then analysed in a liquid scintillation counter. determined by agreement between histology and CLOtest. The study
The PYtest Kit (urea[14C] breath test) is designed for use with the PYtest results are summarized below
capsule, a gelatin capsule for oral administration containing 37 kBq (±20%) Table 1: Study #1 (n=186, Indeterminate results included)
of 14C labelled urea. The urea is adsorbed on sugar spheres and coloured Histology and CLOtest
yellow with fluorescein. [Link] Positive Negative Total
PYtest Positive 51 8 59 ppv.86%
Composition: Indeterminate
(DPM 1 8 9
A gelatin capsule contains: 10mins.) Negative 1 117 118 npv.99%
0.2 g (±20%) sugar spheres containing sucrose and maize starch Total 53 133 186
7.0 µg (±20%) fluorescein sodium sensitivity specificity
96% 88%
1 µg Urea [14C] (37 kBq 14C) (±20%)
Structural Formula: (Urea [14C]): NH2 14CONH2 Notes: PYtest at 10 min. was compared to the gold standard of
Physical Characteristics of 14C biopsy results in which histology and CLOtest concurred. Patients
who did not have both biopsy tests performed, or in whom the tests
Radiation emission: beta-emission, 49 keVmean, 156 keVmax, differed, were excluded from analysis. There was no statistical
no other emissions difference in test accuracy based on gender of patient.
ExternalExternal emission:
emission: No external
No external radiationradiation
hazard. hazard. Low-energy
Low-energy
beta emissions
beta emissions only. Maximum
only. Maximum range ofrange
0.3 mmof 0.3 mm in water.
in water. ppv = positive predictive value ( total PYtest
 positive divided by
PhysicalPhysical 5730 years
Half-life:Half-life: 5730 years true positive)
npv = negative predictive value ( total PYtest  negative divided
Radiation Dosimetry by true negative)
Maximum effective dose (ED) ([Link] positive): 3 µSv /37kBq
STUDY 2:
Breath tests were performed on seventy-six patients (40 men, 36 women)
who had histology and CLOtest performed also. The results are summa-
rized below:
Clinical Pharmacology
The urease enzyme is not present in mammalian cells, so the presence Table 2: Study #2 (n=76, Indeterminate results included)
of urease in the stomach is evidence that bacteria are present. The Histology and CLOtest“ “
presence of urease is not specific for [Link], but other bacteria are not [Link] Positive Negative Total
usually found in the stomach. The principle of the breath test is shown PYtest“ Positive “ 22 0 22 ppv.100%
(DPM Indeterminate 4 2 6
in Figure 1.
10mins) Negative 1 47 48 npv.98%
Figure 1: Principle of Breath Test Total 27 49 76
sensitivity specificity
82% 96%

Notes: PYtest at 10 min. was compared to the gold standard of biopsy

results in which histology and CLOtest concurred. Patients who did not
have both biopsy tests performed, or in whom the tests differed, were
excluded from analysis. There was no statistical difference in test accuracy
based on gender of patient.
ppv = positive predictive value (total PYtest positive divided by
true positive)
npv = negative predictive value (total PYtest negative divided by
true negative)

Table 3: Summary of Accuracy

Study 1 Study 2
*
Sensitivity (95% CI)
Including Indeterminates
0.96 (0.87,1.00) 0.82 (0.62,0.94)
To detect [Link], urea labeled with 14C is swallowed by the patient. If gastric Excluding Indeterminates
urease from [Link] is present, urea is split to form CO2 and NH3 at the 0.98 (0.90,1.00) 0.96 (0.78,1.00)
interface between the gastric epithelium and lumen and 14CO2 is absorbed Specificity (95% CI)
*

into the blood and exhaled in the breath. Including Indeterminates

Following ingestion of the capsule by a patient with [Link], 14CO2 excretion 0.88 (0.81,0.93) 0.96 (0.86,1.00)
in the breath peaks between 10 and 15 minutes and declines thereafter with Excluding Indeterminates
a biological half-life of about 15 minutes. Urea[14C] that is not hydrolysed by 0.94 (0.88,0.97) 1.00 (0.93,1.00)
*
[Link] is excreted in the urine with a half-life of approximately 12 hours. Predictive Values (95% CI)
About 10% of the 14C remains in the body at 72 hours and is gradually Positive Predictive Value
excreted with a biological half-life of 40 days. 0.86 (0.75,0.94) 1.00 (0.85,1.00)
Negative Predictive Value
Clinical Studies 0.99 (0.95,1.00) 0.98 (0.91,1.00)

Two studies were performed. In both studies, patients with gastrointestinal Values in parentheses are 95% confidence intervals
symptoms underwent the breath test and an endoscopy. During the determined by using an exact procedure for binomial
endoscopy, biopsy samples were taken from the antral gastric mucosa for proportions.
 Figure 2.
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 [Link] infection in the human
stomach. N )0F7EF
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Precautions N (@7
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A false positive test could occur in patients who have achlorhydria. Very 

rarely, a false positive test may occur due to urease associated with
Helicobacters other than [Link] (e.g. Helicobacter heilmanii).

Limitations of the Test:

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history when diagnosing [Link] infection.
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infection. If clinical signs and patient history suggest [Link] infection,
repeat the PYtest or use an alternative diagnostic method.

Information for Patients:

6 hours before the test. The patient
It is necessary for the patient to fast for 4
should not have taken antibiotics or bismuth containing products for 1
month, sucralfate for 2 weeks and proton pump inhibitors for 1 week prior to
the test. Instruct the patient not to handle the capsule directly as this may
Adverse Reactions
interfere with the test result. The capsule should be swallowed intact. The There were no adverse reactions reported in clinical trials at a rate > 1%. All
capsule should not be chewed. adverse reactions reported were felt by the investigators to be unrelated to
Carcinogenesis, mutagenesis, impairment of fertility: No studies have the PYtest.
been conducted with urea[14C] to evaluate its potential for carcinogenicity,
impairment of fertility, or mutagenicity. Any suspected adverse reaction should be reported to:

       
               

The Adverse Reactions Advisory Committee (ADRAC)

Drug Interactions: Antibiotics, proton pump inhibitors, sucralfate, and 2IðFHRI3URGXFW5HYLHZ
TGA
bismuth containing drug preparations are known to suppress [Link]. 32%R[
PO Box 100
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Ingestion of antibiotics or bismuth within 4 weeks, sucralfate within 2 weeks Woden, Canberra 2606
       

or proton pump inhibitors within 1 week prior to performing the test may )D[25UHSRUWYLDHPDLOXVLQJD%OXHFDUG
Tel: 02 6232 8380 Fax: 02 6232 8392
give false negative results.
Overdosage
Pregnancy:
In the event of overdose, the patient should drink one glass of water (150
Animal reproduction studies have not been conducted with PYtest mL) every hour to hasten excretion of the radioisotope. Maximum excretion
(urea[14C]). It is also not known whether PYtest can cause foetal harm •
of urea is achieved at a urine output of >2.0mL/min.
when administered to a pregnant woman or can affect reproduction
capacity. When administration of PYtest to a woman of child bearing
potential is considered, information should always be sought about Dosage and Administration
pregnancy.
Nursing mothers: It is not known whether this drug is excreted in human Materials provided:
milk.
As shown in Figure 3, the PYtest Kit contains:
Paediatric Use: Clinical studies in children have not been conducted.
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Post Treatment Evaluation: A negative PYtest 28 days after completing N ,IA

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antibiotic treatment is evidence that the infection has been eradicated. N (@7
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Radiation Safety N (@7
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To allow radiation sources to be effectively compared emissions of various

The kit includes analysis by TRI-MED Distributors, Pty Ltd of one balloon from one patient at
origins are expressed in terms of “effective dose” (ED). The ED of 14C takes
one time point.
into account the fraction of isotope sequestered in each organ tissue (as
recommended by the International Commission for Radiological Protection
60 [ICRP-60] which is adopted in Australia), the biological half life of the FIGURE 3. PYTEST
 KIT
isotope in that tissue, the effective energy of the beta particles compared
with standard ionising radiation (200kV x-ray source) and the administered
dose. ED is expressed in Sieverts (1 Sievert [Sv]; 10-6 Sv = 1µSv).

The maximum estimated ED received from a single administration of PYtest

capsule (37kBq of [14C]-urea) is 3 µSv; Figure 2 summarizes radiation expo-
sure from the PYtest in comparison with other common sources of radia-
tion exposure.

The Australian population is subjected to an annual radiation dose of about

1800µSv to 2400µSv per caput as a result of natural environmental radiation
and the in vivo presence of radionuclides such as natural 14C and 40K in the
body. 2400µSv is equivalent to the radiation dose afforded by the ingestion
of 800 PYtest capsules. A single PYtest procedure is the equivalent of
about 11 hours of normal and essentially inevitable radiation exposure from
the environment.
 

Materials Needed but not Provided:

[Link]/Timer capable of timing an interval up to 10 minutes. Table 5: Confounding Factors
[Link] (40mL)
Factor Result Comment
Dosage: Recent antibiotic False neg. Relapse of partially treated
One PYtest capsule. or bismuth Helicobacter pylori (Hp) may take 1-4
containing weeks.
Procedural Notes: products
Omeprazole (or False neg. These agents suppress Hp in 40% of
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Step by Step Procedure for Balloon: gastroparesis) achlorhydric and/or have bacterial
Table 4: Breath Sample Collection by Balloon overgrowth (non-Hp urease).

Before the 1. Label balloon and fill in breath test report form.
Expected Values
test 2. Check that all materials are present. E
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Minus 1 1. Open the package containing the PYtest capsule [Link].
minute and tip the capsule into the empty Figure 4: Histogram showing DPM distribution for the PYtest
30 mL cup. Do not handle the capsule directly. 40 1 0 0 .0 %
P o s i t iv e ( 3 0 % )
2. Hand the cup to the patient. N e g a t iv e ( 6 4 .5 % ) I nIndeterminate
d e te rm in a te
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9 0 .0 %
Borderline
3. Fill the second cup with 20 mL lukewarm water. 35
Positive
(5.5%) 8 0 .0 %
0 minute 1. Ask the patient to tip the capsule directly into his/her 30
7 0 .0 %
mouth, then swallow it with the 20 mL of lukewarm 25
water. 6 0 .0 %

Cumulative %
Frequency

2. Start the stopwatch when the patient swallows the 20 5 0 .0 %

capsule. 15
4 0 .0 %

3. Discard waste (e.g., capsule packaging, used 3 0 .0 %

10
straws) according to your facility’s regulations. 2 0 .0 %

3 minutes Ask the patient to drink another 20 mL of lukewarm 5

1 0 .0 %

water (in case the capsule may have lodged in the 0 0 .0 %

oesophagus and not yet reached the gastric mucosa).

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10 minutes 1. Push a drinking straw into the neck of the balloon. G o ld S ta n d a r d N e g a tiv e

G o ld S ta n d a r d P o s it iv e

2. Ask the patient to hold his/her breath for 5-10

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3. Tie the neck of the balloon into a tight knot.

4. Check that the balloon label and the breath test )&

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How Supplied
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PYtest
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(2 varies PLEASE CALL TRI-MED DISTRIBUTORS P/L IF YOU HAVE ANY QUESTIONS, OR VISIT OUR WEB
SITE AT [Link]
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Manufactured by: Avent Inc.

Ballard Medical Products
RESULTS 6620
[Link]
Memorial
Peak Place Suite 100
Parkway
Interpretation of results (10 minute sample) Tucson.
Draper -Arizona 85756
UTAH - 84020

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[Link] USA
United States of America


 
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50-199 DPM #@67F7D?;@3F7
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Borderline [Link]
for [Link]
Distributed in Australia by:
B C D E F G H H D I B C D J K B L C I M B N O B H


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before repeating the PYtest
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:3H7 [Link]. 27TH OF NOVEMBER 1998.
: ; < = > ?
AUST R 67146
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24 October 2002 PI1.7.1