Helicobacter pylori, Urea Breath Test - Cleveland HeartLab, Inc.

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: PyloPlus^® UBT Collection Kit

Collection:

Follow instructions provided with PyloPlus^® UBT Collection Kit

Note: This test can only be performed on specimens from patients >17 years old collected in PyloPlus™ breath collection bags.

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 PyloPlus^® UBT test may cause a false negative result. However, a positive result is still valid. Insufficient data are available on pregnant and lactating women.

Transport: Store PyloPlus^® UBT Collection Kit bags at room temperature after collection and ship the same day per packaging instructions included with the provided shipping box.

Note: Paired breath samples (pre and post) collected in PyloPlus^® UBT Collection Kit bags must be submitted together using the ziplock bag provided in the kit. Follow instructions provided with kit.

Stability:

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

Causes for Rejection: Specimens other than PyloPlus^® UBT Collection Kit bags; improper labeling; samples not stored properly; samples older than stability limits; insufficient breath for analysis; single collection bags; specimens from patients <18 years old; specimens not submitted in PyloPlus^® UBT collection bags; uncapped bags

Methodology: Infrared 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 casual relationship between H. pylori and chronic active gastritis, duodenal ulcers, and gastric ulcers has been well documented. UBT PyloPlus^® UBT breath tests provide a non-invasive and nonhazardous method for detecting current H. pylori infection using urea breath analysis.

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.