Specimen

Breath

Collection Medium:

Rejection Criteria:

Bags not fully inflated or only one of the two bags submitted; breath 
collected in tubes; refrigerated or frozen specimens; collect Monday 
through Thursday only; do not collect on Fridays, holidays, day before 
a holiday, or weekends.

Analytic Time:

1-4 days

Reference Range:

Negative

Comments:

Testing kits are available from Specimen Control, 6240 RCP.

Patient preparation:
The patient should fast and abstain from smoking for 1 hour prior to 
test administration  The patient should not have taken antibiotics, 
proton pump inhibitors or bismuth preparations within the previous 14 
days.  These include: Prilosec, Prevacid, Aciphex, Nexium, and 
Pepto-Bismol.  When used to monitor treatment, the test should be 
performed four weeks after cessation of definitive therapy. The patient 
should be informed that the Pranactin-Citric drink that will be 
administered contains phenylalanine.  Phenylketonurics restrict dietary 
phenylalanine.

Test administration:
  1) Label breath collection bags with patient name, MRN, date and
     time of collection, and designate Pre (blue) or Post (pink).
  2) Collect the  baseline breath sample:
     a) Remove cap from collection bag (blue).
     b) Have patient take a deep breath, pause momentarily then exhale
        into the mouthpiece of the bag filling it completely.
     c) Replace cap on the bag.
  3) Prepare Pranactin-Citric solution:
     a) Empty packet from test kit into the cup provided.
     b) Add drinking water up to the fill line (raised ridge).
     c) Replace lid; swirl for up to two minutes until completely
        dissolved. Solution should be clear. The solution is stable up
        to 60 minutes at room temperature.
  4) Instruct patient to drink the solution without stopping using the
     straw provided.  Advise the patient not to "rinse" the mouth with
     the solution before swallowing.
  5) Set timer for 15 minutes. Start timer as soon as the patient has
     completed drinking. Patient should sit quietly without eating,
     drinking, or smoking.
  6) Prepare the post sample collection (pink) bag. At exactly 15
     minutes, have the patient take a deep breath, pause momentarily
     and then exhale to fill the second sample collection bag (pink). 
Note: for a valid result, the post sample must be collected within 13 
to 18 minutes after administration of the Pranactin-Citric Solution.

Return kit to Specimen Control, 6240 RCP.

Sample stability: 1 week only-must reach reference laboratory within a 
week of collection.

Test
Limitations:

A negative result does not rule out the possibility of H. pylori 
infection.  If clinical signs are suggestive of H. pylori infection, 
retest with a new sample or an alternate method.  Known causes of false 
negative results include:
  1. Use of antimicrobials, proton pump inhibitors, and bismuth
     preparations within the two weeks preceding the test.
  2. Administration of the breath test less than four weeks after
     completion of therapy to eradicate H. pylori.
  3. Premature or late collection of the post-dose sample.

Known causes of false positive results include:
  1. Patients with achlorhydria.
  2. Rinsing the Pranactin citric in the mouth allowing contact with
     urease positive bacteria.
  3. The presence of other gastric spiral organisms such as
     Helicobacter heilmanii.

Methodology:

Infrared Spectrophotometric

CPT Code:

83013

See Additional Information:
Fasting Specimen Requirements