Origin |
China |
The Helicobacter Pylori Test Kit is the reagent kit for [14C]-Urea Breath Test (UBT) for the in vitro diagnosis of Helicobacter pylori (H Pylori) infection. A test kit consists of a [14C]-Urea capsule and a breath card. To conduct the test, the subject orally administers the Urea capsule and exhales to a breath card after certain interval. The analysis is done through the measurement on the breath sample with ionization technology by Helicobacter Pylori Detector.
The principle of [14C]-Urea Breath Test
The [14C]-Urea Breath Test (UBT) is based on the detection of the enzyme urease, produced by Helicobacter pylori. Since urease is not present in normal human tissues, and since other urease-producing bacteria do not colonize the stomach, the presence of urease in the stomach can be equated with Helicobacter pylori infection.
In the presence of urease, orally administered 14C urea will be hydrolyzed into ammonia and 14CO2. 14CO2 is absorbed into the blood circulation and exhaled by the lung. The presence of a significant amount of 14CO2 in the exhaled breath indicates active Helicobacter pylori infection.
[14C]-Urea Breath Test offers advantages as below:
Accurate
Sensitivity 95%, specificity 95%-100%.
Comfortable
Non-invasive, no endoscopic tube insertion, well tolerated by patients.
Convenient
Near-patient testing, analysis made on site, minimal inconvenience for patients.
Safe
Negligible radiation burden, no risk of inter-patient cross-infection.
Simple
Easy operation, no special handling required.
Swift
Entire test finished in 25 minutes.
Procedure of [14C]-Urea Breath Test
The test is conducted two hours after meal or with an empty stomach in the morning
1. Swallow a 14C Urea capsule with water
2. Sit for 15 minutes
3. Blow into a breath card for 3-5 minutes
4. Test the breath card with the analyzer
5. The result will be printed after 5 minutes
Specification
1. 40 grains(27.8kBq(0.75μCi)/ grain) of [14C]-Urea capsules / box
2. 40 pieces of breath cards.
The GMP certified [14C]-Urea capsule contains the minimum dose of 0.75μCi [14C]-Urea in the world.
The breath card has been granted two patents. The humanity design for an anti-inhale safety mouthpiece effectively ensure against inhalation during exhaling.
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