PYTEST*

C-Urea Breath Test

14

H. PYLORI DIAGNOSTICS
MADE SIMPLE FOR YOU,
EASY FOR PATIENTS
FROM THE LEADER IN H. PYLORI DIAGNOSTICS

Barry Marshall, M.D.

H. pylori and Gastric Ulcers Simple for you. Easy for Patients.
PYtest* was developed by Barry Marshall, Halyard Health is a leader in Helicobacter
M.D., who, along with Robin Warren, M.D., pylori (H. pylori) diagnostics. The PYtest*
was the first to discover the correlation 14
C-Urea Breath Test is the first and only
between H. pylori and gastric ulcers. currently approved 14C-UBT in the U.S.
Dr. Marshall also developed the CLOtest* market for the diagnosis of H. pylori. Utilizing
Rapid Urease Test. Today, it has become 14
C-labeled urea in breath samples to identify
the most widely used rapid urease test the presence of the H. pylori bacterium,
worldwide for the diagnosis of H. pylori PYtest* features:
and is recognized globally by medical Accuracy
professionals as the “Gold Standard.” • Up to 96% sensitivity and 96% specificity
• Active infection determination versus the
One of the most common chronic presence of antibodies, as
infections worldwide, H. pylori is associated measured by serology
with 95% of duodenal ulcers and 80% of Convenience
gastric ulcers. Clinical studies have shown • Non-invasive, easy-to-swallow
that eradicating H. pylori is effective in gelatin capsules
eliminating or reducing the recurrence of • On-site test administration and
ulcers and may also lower the risk of gastric analysis that can be completed in
cancer. The National Institutes of Health less than 20 minutes
recommends testing for H. pylori in all • Testing not regulated by CLIA†
patients with gastric or duodenal ulcers.
Reimbursement
•R
 eimbursement by Medicare and
many other carriers†

†
Applies to U.S. only
PYTEST*
14
C-Urea Breath Test
PRODUCT ORDERING INFORMATION
HALYARD* PYTEST* 14C-UREA HALYARD* PYTEST* 14C-UREA BREATH TEST
BREATH TEST CAPSULES PROVIDER PURCHASE KITS
Stock # Description Packaging Facility purchases kit and test analysis, then bills insurance carrier and/or
60442 PYtest Capsules
*
10 Each patient for test administration and analysis. Note: Medicare does not allow
60443 PYtest* Capsules 100 Each certain facilities to bill for services that they do not perform. Check with
60437+ PYtest* Capsules 1000 Each local carrier for details.
Includes:
1 – PYtest Capsule
HALYARD PYTEST C-UREA
* * 14
1 – Balloon
BREATH TEST ACCESSORIES 1 – Straw
Stock # Description Packaging 2 – Medicine Cups
60404 PYtest Patient Brochure
*
50 Each 1 – Results Form
60444 Air Pump 1 Each 1 – Directions For Use
60445 PYtest* Breath Collection Fluid, 250ml 1 Each 1 – Alert Form
60446 PYtest* Breath Collection Fluid, 1000ml 1 Each 1 – Return Carton
60447 PYtest* Breath Collection Vials, 200ml 100 Each 1 – Prepaid Shipper Label
60449 PYtest* Medicine Cups 400 Each 1 – Alert Form
60450 PYtest* Needles 100 Each
Stock # Description Packaging
60452 PYtest* Reagent Dispenser, 1- 5ml, for 1 Each
Breath Collection Fluid 60461 PYtest* Provider Purchase Kit, UPS Return 1 Each
60453 PYtest* Reagent Dispenser, 1- 10ml, for 1 Each 60470 PYtest* Provider Purchase Kit, U.S. Priority 1 Each
Scintillation Fluid Mail Return
60454 PYtest* Breath Collection Balloons, Straws 100 Each 60462 PYtest* Provider Purchase Kit, UPS Return 10 Each
60455 Scintillation Fluid, 4 Liters 1 Each 60471 PYtest* Provider Purchase Kit, U.S. Priority 10 Each
60456 PYtest* Standards Set, Background and 14C 1 Each Mail Return
60494 PYtest* Validation Package, 1 Each
3- Collection Balloons, 3- Straws HALYARD* MICROCOUNT* LITE LIQUID
3- Results Forms, 3- Return Cartons
SCINTILLATION COUNTER
Stock # Description Packaging

HALYARD* PYTEST* 14C-UREA BREATH TEST 60495 MICROCOUNT Lite, Single-Sample Liquid 1 Each
*

Scintillation Counter, Weight: 25 lbs., Size:

START-UP PACKAGE 14½" x 6½" x 10"
Provides supplies (except capsules and liquid scintillation counter equipment) 60496 MICROCOUNT* Lite Printer, Miniature 1 Each
Continuous-Feed Dot Matrix Serial Interface
to perform 100 tests on site. The smallest container of Scintillation Fluid
Printer
available provides a supply to perform 400 tests.
Includes:
1 – Air Pump
200 – Needles
100 – Collection Vials
1 – Stopwatch
1 – Bottle Collection Fluid, 250ml + For International sale only
100 – Balloons|100- Straws
1 – Bottle Scintillation Fluid, 4 Liters
100 – Patient Brochures
1 – Sample Breath Test Report Form
400 – Medicine Cups
1 – Validation Package: 3- Balloons, 3- Straws, 3- Return Cartons, 3- Patient

Results Forms

Stock # Description Packaging

60439 PYtest* Start-Up Package 1 Each
ADMINISTRATION AND ANALYSIS IN 5 EASY STEPS

1
The patient swallows a PYtest capsule
containing a small amount of 14C-labeled PYtest* products include test
urea. If the 14C-Urea comes into contact capsules as well as supplies and
with H. pylori in the stomach, it is equipment necessary for on-site
administration and analysis.
hydrolyzed into 14C-carbon dioxide and
ammonia. The carbon dioxide enters the
bloodstream and is exhaled by the patient.

2
Ten minutes after ingesting the capsule,
a breath sample is collected in a mylar
balloon. The breath sample collection
balloon may be analyzed on site or PYTEST* KIT PROGRAM
sent to Halyard Health for analysis. Analysis of the breath sample is
also available at Halyard Health
via the PYtest* Kit Program. The
PYtest* Kit contains all supplies
needed to complete a single test
administration. After the test is
administered, the PYtest* balloon is
sent to Halyard Health for analysis.
Results are typically available within
24 hours of receipt.

3
The contents of the balloon are
transferred into a breath collection fluid,
then liquid scintillation fluid is added to
complete the solution.

4
The MICROCOUNT* Lite Liquid
Scintillation Counter analyzes the breath
sample. Compact in size, it provides
results in five minutes on an LCD display
panel. (A compatible printer or software
for outputting results in hard copy is also
available.) If the breath sample contains
14
C, the patient has H. pylori. If H. pylori
is not present, the 14C-Urea is not
hydrolyzed and is excreted in the urine.

5
On-site test administration and analysis
can be completed in less than 20 minutes.
Therefore, test results can be discussed
with the patient and treatment prescribed
before he or she leaves the office.
PRODUCT SPECIFICATIONS WARNINGS
None
PYtest* (14C-urea Capsules)
PRECAUTIONS

General: After the patient ingests the 14C-Urea capsule, the sample
DESCRIPTION
collected for test purposes is for in vitro diagnostic use only.
PYtest* (14C-Urea) capsules is intended for use in the detection of A false positive test could occur in patients who have achlorhydria. Very
gastric urease as an aid in the diagnosis of Helicobacter pylori (H.pylori) rarely, a false positive test may occur due to urease associated with
infection in the human stomach. The test utilizes a liquid scintillation Helicobacters other than H. pylori (i.e., Helicobacter heilmanni).
counter for the measurement of 14CO2 in breath samples. The capsules
are to be used when analysis is planned at the site where the sample
LIMITATIONS OF THE TEST
is taken.
• The test has been evaluated in outpatients before elective endoscopy.
PYtest* capsule is a gelatin capsule for oral administration containing
• T
 est results should be evaluated with clinical signs and patient history
1µCi of 14C-labeled urea. The urea is adsorbed on sugar spheres and
when diagnosing H. pylori infection.
colored yellow with fluorescein.
• T
 he performance characteristics of the test have not been established
Data on 14C-Urea:
for monitoring the efficacy of antimicrobial therapies for the treatment
Structural Formula (14C-Urea): NH2 14CONH2
of H. pylori infection.
Radiation emission: beta-emission, 49 keVmean, 156 keVmax, no
other emissions  negative result does not completely rule out the possibility of H. pylori
• A
External emission: No external radiation hazard. Low-energy beta infection. If clinical signs and patient history suggest H. pylori infection,
emissions only. repeat the PYtest* or use an alternative diagnostic method.
Maximum range of 0.3 mm in water.
Radiological half-life: 5730 years RADIOACTIVITY
Maximum effective dose equivalent (EDE): 0.3 mrem/µCi
Persons concerned about very low doses of radioactivity may postpone
CLINICAL PHARMACOLOGY the test or may decide to use an alternative means of diagnosis. The test
produces radiation exposure equal to 24 hours of normal background.
The urease enzyme is not present in mammalian cells, so the presence In animal experiments, such low doses of radiation do not carry
of urease in the stomach is evidence that bacteria are present. The measurable risk.
presence of urease is not specific for H. pylori, but other bacteria are
Preclinical studies were not conducted on 14C-Urea. The estimated dose
not usually found in the stomach.
equivalent received from a single administration of PYtest* (1µCi 14C) is
To detect H. pylori, urea labeled with 14C is swallowed by the patient. about 0.3 mrem.
If gastric urease from H. pylori is present, urea is split to form CO2 and
NH3 at the interface between the gastric epithelium and lumen and INFORMATION FOR PATIENTS
14
CO2 is absorbed into the blood and exhaled in the breath. It is necessary for the patient to fast for 6 hours before the test. The
Following ingestion of the capsule by a patient with H. pylori, 14CO2 patient should also be off antibiotics and bismuth for 1 month, and
excretion in the breath peaks between 10 and 15 minutes and declines proton pump inhibitors and sucralfate for 2 weeks prior to the test.
thereafter with a biological half-life of about 15 minutes. 14C-Urea that Instruct the patient not to handle the capsule directly as this may
is not hydrolyzed by H.pylori is excreted in the urine with a half-life of interfere with the test result. The capsule should be swallowed
approximately 12 hours. About 10% of the 14C remains in the body at 72 intact. Do not chew the capsule.
hours and is gradually excreted with a biological half-life of 40 days. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT FOR FERTILITY
CLINICAL STUDIES No studies have been conducted with 14C-Urea to evaluate its potential
for carcinogenicity, impairment of fertility, or mutagenicity.
Two studies were performed. In both studies, patients with DRUG INTERACTIONS
gastrointestinal symptoms underwent the breath test and an endoscopy.
During the endoscopy, biopsy samples were taken from the antral Antibiotics, proton pump inhibitors, sucralfate, and bismuth preparations
gastric mucosa for histological analysis (2 samples, Giemsa stain) and are known to suppress H.pylori. Ingestion of antibiotics or bismuth
rapid urease test (1 sample, CLOtest). Breath samples were mailed to within 4 weeks and proton pump inhibitors or sucralfate within 2
the TRI-MED lab where they were read in a liquid scintillation counter. weeks prior to performing the test may give false negative results.
Results were reported as disintegrations per minute (DPM). Analysis for PREGNANCY
accuracy used the 10 minute breath sample. A breath sample DPM <50 Pregnancy category C. animal reproduction studies have not been
was defined as a negative result. DPM ≥200 was defined as a positive conducted with PYtest* (14C-Urea). It is also not known whether PYtest*
result. DPM in the range of 50-199 was classified as indeterminate. can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity. PYtest* should be given to a pregnant
Study 1 (n=186) Study 2 (n=76) woman only if clearly needed.
Sensitivity
a•
96% 82% NURSING MOTHERS
Specificitya• 88% 96% It is not known whether this drug is excreted in human milk. Because
Positive Predictive Value 86% 100% many drugs are excreted in human milk, caution should be exercised
when PYtest* is administered to a nursing woman.
Negative Predictive Value 99% 98%
PEDIATRIC USE
a
Compared with agreement of CLOtest* and Histology
•
Including indeterminates. If an indeterminate result (50-199 DPM) occurs, Clinical studies in children have not been conducted. However, PYtest*
repeat testing is recommended is expected to work the same in children as in adults. While the dose (1
••
Using community hospitals for study patients capsule) does not need to be adjusted, the child must be able to swallow
INDICATIONS AND USAGE the intact capsule and blow into a straw.
ADVERSE REACTIONS
PYtest* (14C-urea) breath test is indicated for use in the detection of
gastric urease as an aid in the diagnosis of H. pylori infection in the No adverse reactions were reported in clinical trials.
human stomach. The test utilizes a liquid scintillation counter for the OVERDOSAGE
measurement of 14CO2 in breath samples.
Risk from radiation is negligible even with a 1000 capsule overdose
CONTRAINDICATIONS (0.3 rem). If overdose occurs, the patient may drink one glass of water
(150 mL) every hour to hasten excretion of the isotope. Maximum
None excretion of urea is achieved at a urine output of ≥2.0 mL/min.
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