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H. pylori Urea Breath Test

Alternate Name: H. pylori Breath Test

SAL Code:

8769

CPT:

83013

Loinc:

29891-9

Turn Around Time:

1-3 days

Setup:

Daily

Department:

Diagnostic Immunology

Methodology:

IR (infrared) spectroscopy

Specimen Requirements:

Primary Tube:

Bag

Primary Substance:

Breath

Temperature

Period

Stable Ambient:

14 days

Stable Fridge:

No

Stable Frozen:

No

Rejection Criteria:

Received at lab after 13 days of collection; specimens collected from patients that are younger than 3 years of age. Improper labeling, bags not filled, stored, or shipped correctly.

Clinical Info:

The BreathID Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old.

Additional Information:

The BreathID Smart System assay is intended for use to non-invasively measure changes in CO2 in a patient's breath with one specimen collected before ingestion of Citrica solution and another after. The ratio of these exhaled breaths when used as marker may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach.

Sample Collection:

Collection Instructions: (Detailed collection instructions are also included in the test kit.)
1.Identify the two Breath Sample Bags (the blue BASELINE bag and the gray POST INGESTION bag).
2.Prior to sampling the patient’s breath, label each bag with the supplied barcode labels or write the necessary identification information in the appropriate fields on each bag.
3.Collection of the BASELINE breath sample:
a.Remove the cap from the mouthpiece of the blue BASELINE bag.
b.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.
c.If the bag is not full repeat step b.
d.Replace the cap on the bag mouthpiece and firmly press until it clicks and is securely locked into place.
Note: If the patient has not held their breath for 4-5 seconds or does not fill the bag completely, there is a possibility a test result will not be obtainable. The bag is not fully closed if the cap does not click into place. Not fully closing the bag my cause the breath sample to slowly leak out.
4.Preparing the test drink:
Note: Administer the test drink within two hours of preparation, as this is the maximal time for maintaining solution stability.
a.Dissolve the Citrica Powder and the 13C-enriched urea tablet in 5.1 to 6.8 oz. (150 to 200 ml) of tap water in the provided drinking cup.
b.Close the lid firmly using both hands. Place fingers over lid and shake thoroughly for a few minutes, until the Citrica Powder and the 13C-urea tablet are completely dissolved.
Note: Tiny particles may remain visible after thorough mixing. However, if more substantial particulate matter is still present after five minutes of mixing, discard the solution and repeat the procedure with a new kit.
5.Administering the test drink:
a.Give the prepared test drink to the patient.
b.Ensure that the patient drinks the solution through the provided straw.
c.The patient, including pediatric patients aged 3-17 regardless of age and bodyweight, must drink the solution within two minutes and consume the entire amount.
d.Start a timer for 15 minutes.
e.After the patient finishes drinking the solution, record the present time plus (+) another 15 minutes in the Time to Fill field on the gray POST INGESTION bag.
6.Collection of the POST INGESTION breath sample:
a.Fifteen minutes after the administration of the test drink (but not later than 20 minutes after administration) remove the cap from the mouthpiece of the gray POST INGESTION bag.
b.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.
c.If the bag is not full repeat step b.
d.Replace the cap on the bag mouthpiece and firmly press until it clicks and is securely locked into place.

Test Limitations:

Specimen should be collected from a patient that has been fasting at least one hour prior to testing. The patient should not have taken any antimicrobials, proton pump inhibitors, or bismuth preparations within two weeks prior to testing. If the patient did take any of these agents, the results of the test may not be accurate.
Please Note: The solution contains phenylalanine. Caution should be taken when administering to patients with a sensitivity to phenylalanine.

A negative result does not rule out the possibility of H. pylori infection. False negative results can occur with this procedure. If clinical signs suggest H. pylori infection, retest with a new sample or an alternate method. A false positive test may (rarely) occur due to urease associated with other gastric spiral organisms observed in humans such as Helicobacter heilmanni. A false positive test could occur in patients who have achlorhydria.

If the patient has not held their breath for 4-5 seconds or does not fill the bag completely, there is a possibility a test result will not be obtainable. The bag is not fully closed if the cap does not click into place. Not fully closing the bag my cause the breath sample to slowly leak out.

Specimen Handling Instructions:

Assure both filled Breath Sample Bags are correctly labeled, and all fields are complete for future identification.
Place both filled Breath Sample Bags (the blue BASELINE bag and the gray POST INGESTION bag) into a sample transport bag.
Until analyzed, Breath Sample Bags should be stored at room temperature (15-30°C, 59-86°F), protected from direct sunlight and sharp objects. Refrain from applying any external pressure on the Breath Sample Bags.

Test Information:

Components:

Brooklyn Navy Yard
Building 292, Suite 416
63 Flushing Avenue
Brooklyn, NY 11205

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