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.
For concrete data please consult the Instruction for Use in the download box on the top right side.
Our comprehensive immunoassay portfolio includes a number of specialty diagnostic immunoassays for endocrinology, immunology and autoimmunity, as well as for diagnosis of multiple infectious diseases. We are pioneers and market leaders in saliva diagnostics, with over 40 years of experience supplying a broad portfolio of luminescence- and ELISA-based tests, including our highly acclaimed HMGB1 and MuSK-Ab ELISAs.
And as experts in laboratory automation, we can support our customers with the protocols for open ELISA platforms, such as the Freedom EVOlyzer or Thunderbolt®.
All products are only available for sale to laboratory professionals and may not be available in all countries. Availability and regulatory status may vary across regions depending on local country-specific registration. Please always read and follow the instructions for use.
All of our assays have been designed and manufactured to meet the highest global regulatory requirements and quality standards. Tecan is certified under ISO 9001:2015, ISO 13485:2016 and is audited by a notified body according to Medical Device Single Audit Program (MDSAP).
As part of the Tecan Group, we have a leading market position in diagnostics and research, with over 40 years of experience in the development, manufacture and supply of enzyme-, radiolabel- and luminescence-based immunoassays.
Our range of high-quality immunoassays is supported by a diverse portfolio of automated solutions, making us the perfect partner for you and your customers.
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