- Turnaround: 3 - 4 days
- Requires stool sample
It is now well documented that Helicobacter pylori is responsible for up to 90% of duodenal ulcers, 70% of gastric ulcers and the majority of MALT lymphomas. As well, a recent epidemiological study confirmed the link between the infection and an increased risk of developing gastric cancer (NEJM, Vol 345:784-789, 2001, No. 11). The eradication of the infection significantly decreases the development of gastric cancer in patients with precancerous lesions (JAMA, 2004; 291: 187-194).
Helicobacter pylori Stool Antigen Test (HpSA)
The HpSA non-invasive test for accurately diagnosing Helicobacter pylori infections. The Premier Platinum HpSA Plus, an enzyme immunoassay for the detection of Helicobacter pylori antigens in human stool, cleared by the FDA and CE-marked, is now widely used in many countries, as a valuable tool for the H.pylori patients’ management.
Validation studies
The HpSA test was validated in studies including more than 10,000 patients, in many different countries world-wide. More than 40 studies, published in peer-reviewed journals, report an average accuracy exceeding 90%, in both adult and paediatric populations, for diagnosing the infection and for confirming the eradication after the therapy.The test seems to be equivalent to the Urea Breath Test, with the exception of being less influenced by the medications (PPI’s, H2 blockers and antibiotics) which strongly reduce the sensitivity of the urease-based techniques.
The role of the Stool Antigen test in the Primary Care
The HpSA, being more accurate than the serology and more readily available than the Urea Breath Test, is an important option whenever the use of a non-invasive technique is recommended. Cost/benefit analyses support the use of the HpSA in different situations and prevalence of infection. The use of non-invasive tests has been advocated in different strategies for the management of dyspeptic patients in the primary care. The Maastricht Guideline considers as acceptable a “test and treat” approach for patients below 45 years, with no alarm symptoms. “Diagnosis of the infection should be by UBT or Stool Antigen test.” While the serology has a low positive predictive value, because of the high rate of false positive results, the UBT and the HpSA are accurate enough for justifying an eradication therapy. An alternative approach, “test and scope”, suggests the use of non-invasive tests for screening the patients with higher risks to be further investigated with an endoscopy.
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