Medical Necessity Documentation:
Client Notes:
The patient should not have taken antimicrobials, proton pump inhibitors or bismuth preparations within two weeks prior to administering the test. The patient should have fasted at least one hour before administering the solution. The Citrica Powder solution contains 84 mg of phenylalanine per packet. The test may not be suitable for patients with phenylketonuria whose dietary phenylalanine should be restricted. For Office Collection, please contact Client Response at 260-266-1500 (option 1) to request the BreathID Hp Collection Kit. Safety and effectiveness has not been established in patients under the age of 3. The H. pylori stool antigen assay is FDA approved for use on specimens from pediatric patients. The BreathID Hp collection kit should not be used until four weeks or more after the end of tratment for the eradication of H. pylori as earlier post-treatment assessment may give false negative results.
Patient Preparation:
The patient should not have taken antimicrobials, proton pump inhibitors or bismuth preparations within two weeks prior to administering the test. The patient should have fasted at least one hour before administering the solution. The Citrica Powder solution contains 84 mg of phenylalanine per packet. The test may not be suitable for patients with phenylketonuria whose dietary phenylalanine should be restricted.
Specimen Requirements:
BreathID Hp Collection Kit
Collection Instructions:
1. To collect the baseline breath sample, remove the cap from the mouthpiece of the blue baseline bag. Instruct the patient to take a deep breath, hold their breath for 4 to 5 seconds and then exhale directly into the mouthpiece of the blue baseline breath bag until completely full. If the bag is not full, repeat taking a deep breath, holding their breath for 4 to 5 seconds and exhaling into the mouthpiece of the blue baseline bag until full. Replace the cap on the bag mouthpiece and firmly press until it clicks and is securely locked into place.
2. Dissolve the Citrica Powder and urea table in 150 to 200 ml of tap water in a single use drinking cup that is at least 8 oz in capacity. Stir thoroughly with the provided straw until completely dissolved. Give the prepared test drink to the patient. Ensure that the entire solution is drunk through the straw within 2 minutes.
3. Wait 15 minutes.
4. After 15 minutes, remove the cap from the mouthpiece of the gray post-ingestion bag. Instruct the patient to take a deep breath, hold their breath for 4 to 5 seconds and then exhale directly into the mouthpiece of the gray post ingestion bag until it is full. If the bag is not full, repeat taking a deep breath, holding their breath for 4 to 5 seconds and exhaling into the mouthpiece of the gray post-ingestion bag until full. Replace the cap on the bag mouthpiece and firmly press until it clicks and is securely locked into place.
Transport & Storage: Temperature/Stability:
7 days Ambient
Rejection Criteria:
Patients <3 years of age; use of a collection container other than the BreathID Hp Collection Bags
Reference Range:
Negative
Critical Ranges:
Test Comments:
Antimicrobials, proton pump inhibitors, and bismuth preparations are known to suppress H. pylori. Ingestion of these in the 2 weeks prior to H. pylori diagnostic testing may lead to false negative results. If clinically indicated, the test may be repeated on a new specimen obtained two weeks after discontinuing treatment. A positive result is still clinically valid.
Methodology:
Infra-red Spectrophotometry (IR)
Clinical Significance:
The BreathID Hp collection system is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori infection in the stomach.
Documentation:
Custom Panel:
No
PRODUCTION SCHEDULE
Turn Around Time:
3 to 5 days
Days Performed:
Monday, Wednesday, Friday
Sites Performed:
Parkview Regional Medical Center
PHL Test Code:
HPYBR
EPIC Test Code:
LAB572
Alternate Test Names:
H Pylori Breath Test; H. Pylori Breath Test; H. pylori UBiT (R); Helicobacter pylori Breath Test; Helicobacter pylori Urea Breath Test, Infra-red (U; H-Pylori Breath Test
Included Tests:
CPT Coding:
83013