PYTEST Capsule (14C-Urea Breath Test) Ref.[11131] Active ingredients: Urea

None.

No adverse reactions were reported in clinical trials.

Limitations of the Test

• The test has been evaluated in outpatients before elective endoscopy.
• Test results should be evaluated with clinical signs and patient history when diagnosing H.pylori infection.
• The performance characteristics of the test have not been established for monitoring the efficacy of antimicrobial therapies for the treatment of H.pylori infection.
• A negative result does not completely rule out the possibility ofH.pylori infection. If clinical signs and patient history suggest H.pylori infection, repeat the PYtest¹ or use an alternative diagnostic method.
• The integrity of samples in balloons sent by air transport has not been adequately determined. In studies simulating the effects of air transport for two to seven days at temperatures of -40°C, 20°C and 55°C, no balloon failures were observed. However, the data could not provide statistical determination that no changes in ¹⁴CO₂ concentration took place.
• For ground transport, integrity of samples in balloons has not been determined beyond 7 days. During this time frame, concentration of labeled CO₂ can decrease as much as 0.36% per day.

Radioactivity

Persons concerned about very low doses of radioactivity may postpone the test or may decide to use an alternative means of diagnosis. The test produces radiation exposure equal to 24 hours of normal background. In animal experiments, such low doses of radiation do not carry measurable risk.

Preclinical studies were not conducted on ¹⁴C-urea. The estimated dose equivalent received from a single administration of PYtest¹ (1µCi ¹⁴C) is about 0.3 mrem.

After the patient ingests the ¹⁴C-urea capsule, the sample collected for test purposes is for in vitro diagnostic use only.

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 H.pylori (i.e. Helicobacter heilmanni).

It is necessary for the patient to fast for 6 hours before the test. The patient should also be off antibiotics and bismuth for 1 month, and proton pump inhibitors and sucralfate for 2 weeks prior to the test. Instruct the patient not to handle the capsule directly as this may interfere with the test result. The capsule should be swallowed intact. Do not chew the capsule.

Antibiotics, proton pump inhibitors, sucralfate, and bismuth preparations are known to suppress H.pylori. Ingestion of antibiotics or bismuth within 4 weeks and proton pump inhibitors or sucralfate within 2 weeks prior to performing the test may give false negative results.

Pregnancy category C.

Animal reproduction studies have not been conducted with PYtest¹ (¹⁴C-urea). It is also not known whether PYtest¹ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PYtest¹ should be given to a pregnant woman only if clearly needed.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PYtest¹ is administered to a nursing woman.

Clinical studies in children have not been conducted. However, PYtest¹ is expected to work the same in children as in adults. While the dose (1 capsule) does not need to be adjusted, the child must be able to swallow the intact capsule and blow into a straw.