TEST DIRECTORY... | MIDx Labs

H. PYLORI BREATH TEST (HPB)

Non-invasive urea breath test used to detect active Helicobacter pylori infection by measuring urease activity in exhaled breath, commonly used both for initial diagnosis and to confirm eradication after treatment.

LIS TEST CODE: HPB

CPT CODE: 83013

ALIASES: H. Pylori Breath Test, Urea Breath Test, UBT, ¹³C-UBT, BreathID, IDkit Hp Two

METHODOLOGIES: BreathID Smart platform: Isotope-Selective Non-Dispersive Infrared Spectroscopy

SPECIMEN:

- Type: Human breath (baseline and post-ingestion samples)

- Container: IDkit Hp Two collection kit: Blue bag (BASELINE), Gray bag (POST-INGESTION), 75 mg ¹³C-urea tablet, 4.3 g Citrica (citric acid) packet, straw, drinking cup, 4 labels, sample transport materials

- Minimum Volume Required: Full patient exhalation into each bag per kit instructions; both the Blue baseline bag and Gray post-ingestion bag must be submitted together as a pair; an incomplete pair cannot be tested.

- Patient Collection Procedure:

Patient Preparation Requirements (false negatives are common if not followed):

No antibiotics or bismuth-containing compounds (e.g., Pepto-Bismol) for 4 weeks prior to testing.
No proton pump inhibitors (PPIs) for 2 weeks prior to testing.
No H2 blockers or sucralfate for 2 weeks prior to testing.
Patient should be fasting for at least 1 hour prior to testing.
Do not administer to patients under age 3; screen for phenylketonuria (PKU) and citric acid/citrus sensitivity before administering, since Citrica contains phenylalanine and citric acid.

(1) Patient begins by fully exhaling into the Blue (BASELINE) bag.

(2) Patient then dissolves the Citrica packet in water, drinks it, swallows the 75 mg ¹³C-urea tablet, and waits the manufacturer-specified interval before exhaling fully into the Gray (POST-INGESTION) bag.

(3) Label both bags (patient name, DOB, and date/time of collection required) and submit together.

- Storage/Handling: Keep bags upright and sealed at room temperature; avoid puncture or crushing. Avoid extreme heat during transport.

- Stability:

Room Temperature (20-25 °C): 14 days

Refrigerated (2-8 °C): Not Accepted

Frozen (-20 °C or colder): Not Accepted

- Turnaround Time: 24 hours from receipt.

Special Instructions: This test detects active infection only and does not distinguish past/treated infection from current infection. Sensitivity for the BreathID Hp Lab System (which the IDkit Hp Two kit runs on) has been reported at 100% with 97.9% specificity in manufacturer validation studies. For test-of-cure, testing should not be performed sooner than 4 weeks after completion of eradication therapy to avoid false-negative results from transient bacterial suppression.

REJECTION REASONS: Unpaired/Incomplete Sample Set (missing Blue or Gray bag), Patient Prep Not Verified (recent antibiotic/PPI/bismuth use not documented), Bag Leaking/Punctured/Deflated, Unlabeled/Mislabeled Specimen, Stability Violation, Patient Under 3 Years of Age

REFERENCE RANGES:

Males & Females:

>= 3 years of age: Not Detected