Helicobacter pylori Detect stool antigen ELISA

Helicobacter pylori Detect stool antigen ELISA

Direct and non-invasive detection of antigens in stool

The Hp Detect™ Stool Antigen ELISA is an in vitro diagnostic qualitative enzyme immunoassay for the detection of Helicobacter pylori (H. pylori) antigens in human stool or feces. The Hp Detect™ Stool Antigen ELISA is intended to aid in the initial diagnosis and post-therapy diagnosis of H. pylori infection. Additionally, the test may be used to assess H. pylori infection status after treatment. Retesting at a minimum of 4 weeks after the completion of treatment may be done to assess H. pylori status. Test results should always be taken into consideration by the physician in conjunction with patient’s clinical information (history and symptoms). For Professional Use Only / For Prescription Use Only.

Explanation

H. pylori is a bacterium that colonizes the upper Gastrointestinal (GI) tract of humans which has been linked to gastric disease such as peptic ulcers, gastritis, dyspepsia, and stomach cancer [1]. It is estimated that ~50% of the world’s adult population is infected with H. pylori [2]. The majority of those infected remain asymptomatic and do not require treatment (colonized individuals). H. pylori has been identified as a Group I carcinogen, and ~89% of all gastric cancers can be attributable to H. pylori infection [2]. The current standard for diagnosis of H. pylori infection, especially for those exhibiting alarm symptoms (e.g. GI bleeding, sudden weight loss, excessive vomiting, anemia), is endoscopy and biopsy, followed by culture, histology, and/or rapid urease test (RUT) of the biopsied tissue [1]. For patients not exhibiting alarm symptoms, non-invasive techniques may be used for diagnosis, including the urea breath test (UBT), stool antigen tests, or serum tests for antibodies to H. pylori. Tests for the detection of antigen in stool (feces) offer a means for detection of H. pylori when endoscopy is not required. The Hp Detect™ Stool Antigen ELISA provides direct and non-invasive detection of H. pylori antigens in stool as an aid to diagnose infection. Moreover, after completion of a course of treatment for H. pylori infection, the Hp Detect™ Stool Antigen ELISA can allow for assessment of effectiveness of treatment.

Benefits of the assay:

Excellent performance post-therapy:

14 paired (pre-and post-therapy) retrospective specimens from one international site. All subjects (n=14) initially tested positive for H. pylori by CRM** (histology and RUT#),
and all completed eradication therapy. Post-therapy samples were collected at a minimum of 4 weeks after completion of eradication therapy.