Specimen:

Stool

Collection Medium:

Minimum:

Adult preferred minimum: 5 g stool in clean unpreserved stool container
Adult absoluate minimum: 1 g stool in clean unpreserved stool container

Pediatric minimum:  0.5 g unpreserved stool

Rejection Criteria:

Any preservatives or tissue.

Delivery Instructions:

Submit specimen to laboratory as soon as possible after collection.

Analytic Time:

2 working days (upon receipt)

Reference Range:

Negative

Test
Limitations:

1. The test is qualitative and no quantitative interpretation should
   be made with respect to the values.

2. Test results should be used in conjunction with information
   available from the patient clinical evaluation and other diagnostic
   procedures.

3. Antimicrobials, proton pump inhibitors and bismuth preparations are
   known to suppress H. pylori, and ingestion of these prior to
   H. pylori testing (culture, histology, rapid urease, UBT, antigen)
   may give a false negative result. If a negative result is obtained
   for a patient ingesting these compounds within two weeks prior to
   performing the Premier Platinum HpSA test, it may be a false
   negative result and the test should be repeated on a new specimen
   obtained two weeks after discontinuing treatment. A positive result
   for a patient ingesting these compounds, within two weeks prior to
   performing the Premier Platinum HpSA test, should be considered
   accurate.

   As an example, patients with H. pylori were placed on a proton pump
   inhibitor (Lansoprazole) or bismuth for 2 weeks, and tested with
   the Premier Platinum HpSA and a urea breath test. Patients were
   then taken off treatment for 2 weeks and retested. At the end of
   treatment, both assays were negative for some patients, but
   returned to positive 2 weeks post-treatment (see table).

                           Treatment for PPI
                       Premier Platinum HpSA           Breath Test
      Time Point       Pos/Total  % Positive      Pos/Total  % Positive
  End of Treatment       15/20       75.0%          12/20       60.0%
2 Week Post-Treatment    19/20       95.0%          18/20       90.0%


                           Treatment for Bismuth
                       Premier Platinum HpSA           Breath Test
      Time Point       Pos/Total  % Positive      Pos/Total  % Positive
  End of Treatment       15/20       75.0%          11/20       55.0%
2 Week Post-Treatment    19/20       95.0%          18/20       90.0%


4. Performance characteristics have not been established for watery,
   diarrheal stools.

5. Performance characteristics have not been established in pediatric
   populations (< 18 years).

6. Performance characteristics have not been established in
   asymptomatic populations.

7. The Premier Platinum HpSA test can detect 184ng H. pylori
   protein/ml of stool.

8. H2 blockers do not interfere with positive results.

Methodology:

Enzyme Immunoassay

CPT Code:

87338