Kibion

Heliprobe® System

A Urea Breath Test perfectly suited for primary diagnosis and for post treatment follow-up of Helicobacter pylori infection.
It is a reliable, safe and cost-effective near-patient testing system consisting of three components: HeliCap™, BreathCard™ and Heliprobe® Analyzer.

e-IFU

Heliprobe® System is a method with unique advantages:

  • Convenience – Easy to use, near patient testing, no need to send sample for analysis
  • Comfort – Painless, no invasive gastroscopic tubing
  • Rapid – Samples are ready for analysis in only 10 minutes with test result available in 5 minutes

Heliprobe® System consists of three components:

  • Heliprobe® Analyzer
  • HeliCap™ – 14C-urea capsules (Mayoly Spindler Laboratories)
  • BreathCard™

Principles

The Heliprobe® system is an in vitro diagnostic device for the qualitative detection of Helicobacter pylori infection in the stomach, based on the carbon-14-labeled urea breath test (14C-UBT). This is a non-invasive method that allows direct measurement of bacterial urease activity in the gastric mucosa.

H. pylori secretes urease, which can hydrolyze urea into ammonia and carbon dioxide. When carbon-14-labeled urea (1 µCi, 37 kBq) is administered orally (HeliCap™ capsule), the enzymatic reaction releases 14CO2, which rapidly diffuses into the blood and is eliminated by pulmonary ventilation.

Exhaled air is collected in a BreathCard™. This is a collection cassette equipped with a filter that adsorbs exhaled CO2 and a colorimetric saturation indicator. The latter will be analyzed by the Heliprobe® Analyzer.

The Analyzer displays a numerical index:

  1. No infection
    (activity close to background noise)
  2. Borderline result,
    requiring confirmation
  3. Active infection confirmed
    (H. pylori present)

The detection of this 14CO2 in exhaled air is a direct and specific marker of active infection.

What about radioactivity?

The Heliprobe® System uses the drug Helicap™, which contains a very small amount of radioactive carbon (14C). Radioactivity is a natural form of energy emitted by certain unstable atoms. We are all exposed to it every day, through the air we breathe, the food we eat, and even the materials around us.

The dose contained in Helicap™ is 1 microcurie (1 µCi).

To understand what this means:

  • 1 µCi corresponds to 37,000 disintegrations per second (a physical unit called Becquerel).
  • This is a measure of radioactive activity, but it does not mean that all of this energy is absorbed by the body.
  • The actual exposure for the patient is extremely low: approximately 0.1 millisievert (mSv), which is less than one-thousandth of the average dose we receive naturally in a year (approximately 2.5 to 3 mSv).

In other words, taking the Heliprobe® test is equivalent to receiving a dose comparable to that of a few hours’ flight or eating a few bananas (which naturally contain radioactive potassium 40K).

14C-labeled urea is used to detect the possible presence of Helicobacter pylori bacteria in a simple, quick, and non-invasive manner. The body eliminates this labeled carbon mainly through respiration within minutes of ingestion.

Common situationDose received (mSv)Comparison with Helicap®
Heliprobe® test (1 µCi of 14C)~ 0.1 mSv-
Flight Paris → New York (one way)~ 0.03–0.05 mSv2–3 times less
Dental X-ray~ 0.005 mSv20 times less
Natural background radiation in 1 year~ 2.5–3 mSv25–30 times more
Eating 10 bananas (natural 40K radioactivity)~ 0.0001 mSv1,000 times less

Test procedures

Swallow
HeliCap™

Wait 10 minutes.
Breath into BreathCard®

Insert BreathCard® into
Heliprobe® Analyser

Read the result
after 5 minutes

Video 1
Lecture
Video 2
Lecture

FAQ about Heliprobe® System