PYTEST

What it is

PYTEST is a urea breath test for detecting Helicobacter pylori. Each clear gelatin capsule contains 1 μg yellow beads equivalent to 37 kBq of 14C. PYTEST is a qualitative and non-invasive method for the diagnosis of Helicobacter pylori (H. pylori).

Approved indications

— Detection of gastric urease as an aid in the diagnosis of H. pylori infection in the human stomach.

Dosing overview

Adults are administered one PYTEST capsule. Clinical studies in children have not been conducted. The capsule is for oral administration and should be swallowed intact without chewing. The patient should fast for 4 hours prior to the test and should not have taken antibiotics and bismuth containing products for 1 month, proton pump inhibitors for 1 week or sucralfate for 2 weeks prior to the test.

Key safety warnings

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 (for example, Helicobacter heilmannii). The capsule should not be handled directly as this may interfere with the test result. A negative result does not completely rule out the possibility of H. pylori infection, and if clinical signs and patient history suggest H. pylori infection, repeat testing with PYTEST or use of an alternative diagnostic method is recommended. Antibiotics, proton pump inhibitors, sucralfate and bismuth-containing drug preparations are known to suppress H. pylori and ingestion of antibiotics or bismuth within 4 weeks, sucralfate within 2 weeks or proton pump inhibitors within 1 week prior to the test may give false negative results.

Contraindications

Hypersensitivity to the active substance or any of the excipients.

Regulatory history

PYTEST was first approved on 16 December 1998 (ARTG 67146). A second variant was registered on 10 July 2025 (ARTG 491430).