Helicobacter pylori, Urea Breath Test

Cleveland HeartLab H, Test

NEW YORK DOH APPROVED: YES

CPT Code: 83013
Order Code: 1374
Alternative Names:
Breath Test, UBiT, Urea Breath Test, H. pylori
ABN Requirement:
No
Specimen: Human Breath
Volume:  Not Applicable
Minimum Volume:  Not Applicable
Container: BreathTek™ UBT Collection Kit

Collection:

  • Follow instructions provided with BreathTek™ UBT Collection Kit

Note: This test can only be performed on specimens from patients >17 years old. Patients 3-17 years of age must order Helicobacter pylori Urea Breath Test, Pediatric.

Fasting: Patient should fast one hour before collection of baseline breath sample.

Patient Preparation: Use of antimicrobials, proton pump inhibitors, or bismuth preparations within two weeks prior to administering the BreathTek™ UBT may cause a false negative result. However, a positive result is still valid. Pranactin®-Citric contains a small amount of aspartame sweetener. Test may not be suitable for patients with phenylketonuria whose dietary phenylalanine should be restricted.

Transport: Store BreathTek™ UBT Collection Kit bags at room temperature after collection and ship the same day per packaging instructions provided with the Cleveland HeartLab shipping box.

Note: Paired breath samples (pre and post) collected in BreathTek™ UBT Collection Kit bags must be submitted together. Follow instructions provided with kit.

Stability:

Ambient (15-25°C): 7 days
Refrigerated (2-8°C): Not Acceptable
Frozen (-20°C): Not Acceptable
Deep Frozen (-70°C): Not Acceptable

Causes for Rejection: Specimens other than BreathTek™ UBT Collection Kit bags; improper labeling; samples not stored properly; samples older than stability limits; specimens from patients <3 years old

Methodology: Infra-red Spectrophotometry (IR)

Turn Around Time:  2 to 4 days

Reference Range: Not detected

Clinical Significance: Helicobacter pylori is a gram-negative microaerophilic curved bacillus with an affinity for human gastric mucosa. H. pylori has been identified as an important pathogen in the upper GI tract. The causal relationship between H. pylori and chronic active gastritis, duodenal ulcers, and gastric ulcers has been well documented. BreathTek™ UBiT for H. pylori is a non-invasive, non-radioactive method for detecting urease activity associated with H. pylori infection. It is FDA approved to confirm cure and offers 95.2% sensitivity and 89.7% specificity compared with endoscopic methods.

The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.