Features and Benefits
- Rapid whole blood/serum test for H. pylori.
- Test results in 3 – 7 minutes.
- CLIA complexity: waived (Whole Blood)
- Cassette format.
- CPT Code: 86318QW
Helicobacter pylori has been associated with a variety of gastrointestinal diseases including gastritis, duodenal and gastric ulcer, non-ulcer dyspepsia, gastric adenocarcinoma and lymphoma. The exact role that H. pylori plays in gastrointentinal disease still needs to be precisely defined and is the subject of ongoing research. However, the prevalence rates for H. pylori infection, as demonstrated by histological and bacteriological methods, can approach 90% in patients who present clinical symptoms of the gastrointestinal diseases listed above. H. pylori does not appear to invade the bloodstream since no isolates yet have been detected using commercial blood culture methods. H. pylori infections occur in human populations throughout the world. In developed countries, about 50% of the population may have H. pylori infection by the age of 60 years, while only 10-20% of adults in the third decade of life have it.
In patients who present clinical symptoms relating to the gastrointestinal tract there are two major methods of investigation: invasive and noninvasive. Invasive methods include culture of gastric biopsy samples, histologic examination of stained biopsy specimens, or direct detection of the urease activity in the biopsy. These methods require a biopsy sample by endoscopy, which is expensive, and usually results in discomfort and risk to the patient. Noninvasive techniques include urea breath tests and serological methods. Urea breath tests require the use of a small amount of radioactivity and a mass spectrometer. Serologic tests are employed to detect antibodies as human immune system response to H. pylori. Two methods appear to be of great interest regarding their use in H. pylori routine serology, namely the ELISA and the Western immunoblot because they offer the most versatility in regards to immunoglobulin specificity and relative ease of use.
This H. pylori whole blood/Serum Cassette Test detects lgG antibodies specific to H. pylori infection in patient’s blood or serum. It is a noninvasive method and does not use radioactive isotopes; the assay procedures are easy and do not require professional training; it provides a rapid result. It is a useful on-site aid in the diagnosis of H. pylori infection.