1 – Program overview

This external quality assessment program is intended for laboratories performing the urea breath test as part of Helicobacter pylori research.

It allows the accuracy of the dosage of CO₂ labelled with carbon 13 in the T0 (delta) and T30 (delta) tubes, as well as the T30-T0 difference (DOB). It is suitable for infrared and mass spectrometry techniques using transparent tubes with a pierceable cap.

Statistical reports are sent with supporting comments from the expert clinical biologists / program coordinators.

Several concentration levels are tested.

For this program, a single kit is used to assess one analyser only (one kit per analyser is required).

This program is intended for tube-based collection only (not suitable for bag-based collection).

2 – Assessment frequency

Number of surveys per year: 4
Number of control samples per survey: 2
Number of samples per year: 8

3 – List of analytes assessed

• Tube T0 delta
• Tube T30 delta
• T30-T0 difference (DOB)
• Test results

4 – Description of the control samples

Control samples of synthetic air spiked with carbon-13 isotope from urea, ready to use.