Urea Breath Test Infrared (UBIT™)
Test Summary
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 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.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
Patient must be off antibiotics, proton-pump inhibitors; (i.e.. Prilosec™, Nexium™, Protonix™, Aciphex™, and Bismuth) preparations two weeks prior to administration of test.
Human Breath: Paired breath samples (pre and post) collected in bags and must be submitted together. Follow instructions provided with kit. Patient preparation:
Human Breath: Paired breath samples (pre and post) collected in bags and must be submitted together. Follow instructions provided with kit. Patient preparation:
Minimum Volume
N/A
Instructions
Patient should fast one hour before collection of baseline breath sample. Patient must be off weeks prior to administration of test. Pranactin®-Citric contains a small amount of aspartame sweetener.
Test may not be suitable for patients with phenylketonuria whose dietary phenylalanine should be restricted.
The test can only be performed on specimens from patients greater than 3 years old. NOTE: For patients aged 3-17, a Pediatric UHR Calculation Card must be completed at the time of testing.
Test may not be suitable for patients with phenylketonuria whose dietary phenylalanine should be restricted.
The test can only be performed on specimens from patients greater than 3 years old. NOTE: For patients aged 3-17, a Pediatric UHR Calculation Card must be completed at the time of testing.
Patient Preparation
N/A
Storage
Capped Blue and Gray BreathID collection bags
Transport Temperature
Room Temperature
Specimen Stability
- Room Temperature = 7 days
- Refrigerated = unacceptable
- Frozen = unacceptable
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Reject Due to Thawing or Any Other Rejections
Reject specimen types other than appropriate bags.
Reject specimens on patients younger than 3 years old if card is not completed. NOTE: For patients aged 3-17, a Pediatric UHR Calculation Card must be completed at the time of testing.
Refrigerated and/or frozen specimen.
Reject specimen types other than appropriate bags.
Reject specimens on patients younger than 3 years old if card is not completed. NOTE: For patients aged 3-17, a Pediatric UHR Calculation Card must be completed at the time of testing.
Refrigerated and/or frozen specimen.
Order Code
HPBT
EPIC (Premier) Code
LAB4344
Includes
N/A
CPT Code
- 83013
Billing Code
- 301790
CPT Statement
Methodology
Infrared Spectrophotometry
FDA Status
Waived
Physician Attestation of Informed Consent
N/A
Testing Laboratory
CompuNet Clinical Laboratories, LLC
2308 Sandridge Drive
Moraine OH, 45439
2308 Sandridge Drive
Moraine OH, 45439
Department
Molecular/Serology
Reference Range
| SEX | AGE | Report Normals |
| N/M/F | 1000Y | Negative |
Setup Schedule / Expected Turnaround Time
Monday - Friday; BS; Report available: 1 - 3 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
Patient must be off antibiotics, proton-pump inhibitors; (i.e.. Prilosec™, Nexium™, Protonix™, Aciphex™, and Bismuth) preparations two weeks prior to administration of test.
Human Breath: Paired breath samples (pre and post) collected in bags and must be submitted together. Follow instructions provided with kit. Patient preparation:
Human Breath: Paired breath samples (pre and post) collected in bags and must be submitted together. Follow instructions provided with kit. Patient preparation:
Minimum Volume
N/A
Instructions
Patient should fast one hour before collection of baseline breath sample. Patient must be off weeks prior to administration of test. Pranactin®-Citric contains a small amount of aspartame sweetener.
Test may not be suitable for patients with phenylketonuria whose dietary phenylalanine should be restricted.
The test can only be performed on specimens from patients greater than 3 years old. NOTE: For patients aged 3-17, a Pediatric UHR Calculation Card must be completed at the time of testing.
Test may not be suitable for patients with phenylketonuria whose dietary phenylalanine should be restricted.
The test can only be performed on specimens from patients greater than 3 years old. NOTE: For patients aged 3-17, a Pediatric UHR Calculation Card must be completed at the time of testing.
Patient Preparation
N/A
Storage
Capped Blue and Gray BreathID collection bags
Transport Temperature
Room Temperature
Specimen Stability
- Room Temperature = 7 days
- Refrigerated = unacceptable
- Frozen = unacceptable
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Reject Due to Thawing or Any Other Rejections
Reject specimen types other than appropriate bags.
Reject specimens on patients younger than 3 years old if card is not completed. NOTE: For patients aged 3-17, a Pediatric UHR Calculation Card must be completed at the time of testing.
Refrigerated and/or frozen specimen.
Reject specimen types other than appropriate bags.
Reject specimens on patients younger than 3 years old if card is not completed. NOTE: For patients aged 3-17, a Pediatric UHR Calculation Card must be completed at the time of testing.
Refrigerated and/or frozen specimen.
Result Information
Methodology
Infrared Spectrophotometry
Testing Laboratory
N/A
Reference Range
| SEX | AGE | Report Normals |
| N/M/F | 1000Y | Negative |
Setup Schedule / Expected Turnaround Time
Monday - Friday; BS; Report available: 1 - 3 days