April 2023: Updates to H. pylori Urea Breath Test

Immediate Test Change

Updates to H. pylori Urea Breath Test (HPYLBR)

Effective May 2, 2023.

Updated Test

Helicobacter pylori Breath Test (HPYLBR)

Effective May 2, 2023, the Immunopathology Laboratory section of Cleveland Clinic Laboratories will provide a new H. pylori urea breath test.

The qualitative test, based on infrared spectroscopy using 13C, is an aid in diagnosing active infection with Helicobacter pylori and post-treatment monitoring in adult and pediatric patients ages 3-17 years old.

Changes to Specimen Collection

Specimens must be collected with the Meridian Bioscience collection kit; otherwise, testing will be canceled.

Collection Kits

The BreathID® Hp® Two test requires specimen collection with the BreathID® IDkit Hp® Two kit.

One box contains five kits. Each kit contains:

  • (1) Blue baseline breath collection bag
  • (1) Grey post-ingestion breath collection bag
  • 75mg 13C-urea tablet
  • 4.3g package of Citrica (citric acid)
  • Straw
  • Drinking cup
  • User guide
  • (4) Labels
  • Sample transport bag
  • Package insert

Test Overview

Test Name

Helicobacter pylori Breath Test

Test Code

CPT Code

83013

Methodology

13C Infrared Spectroscopy

Specimen Type

1 baseline (blue) and 1 post-dose (gray) breath sample bag collected with a BreathID® IDkit Hp® One kit

Stability

Ambient
14 days

Refrigerated
Unacceptable

Frozen
Unacceptable

Reference Range

Negative

Clinical Information

The Urea Breath Test is used as an aid in the diagnosis of current infection with Helicobacter pylori.

Limitations

Despite very high specificity, false positive results may occur due to other gastric organisms, such as H. heilmanni, as well as in patients with hypo- or achlorhydria.

False-negative results may occur in patients who have received antibiotics, proton pump inhibitors, or bismuth preparations.

Clinical correlation is required.