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GastroPanel

Overview

GastroPanelblood test for the diagnosis of

Atrophic Gastritis

a high priority for Gastroscopy

 

First line diagnostic test for dyspepsia in Primary Care

Dyspepsia is a universal clinical problem affecting 20-40% of the population and carrying an economic impact of £500m per year. Symptoms related to the stomach account for around 4% of all GP consultations and while half of these appointments are for functional (non-ulcer) dyspepsia, functional gastrointestinal disorders constitute 40% of all gastrointestinal referrals. 

Following referral for endoscopy, the diagnostic yield is often low with 50-70% of Gastroscopies identifying no pathology. At a time when there is an ever increasing burden on endoscopy resources and pressure to improve quality standards in endoscopy there is a growing need for tests that help manage patients with gastric symptoms in Primary Care prior to referral.

What is GastroPanel?

GastroPanel® is a blood test for dyspeptic patients presenting with stomach complaints. By measuring four stomach-specific biomarkers it transforms patient management by identifying patients who are at risk of diseases characterised by or related to Atrophic Gastritis including:

  • Gastric Cancer
  • Gastric Ulcer
  • Hypo-/achlorhydria
  • Vitamin and micronutrient deficiency
This enables GPs to confidently identify patients that should be referred for specialist opinion by classifying patients according to risk.

GastroPanel® identifies the highest known risk factor for Gastric Cancer (GCa) – a progressive condition called Atrophic Gastritis which is caused by Helicobacter pylori infection and autoimmune disease. This pre-neoplastic condition can now be diagnosed easily alongside H. pylori by means of this simple blood test in primary care.

Identifying significant disease earlier

Atrophic Gastritis is a high-risk, chronic inflammatory condition of the gastric mucosa and is considered the most important risk factor for Gastric Cancer (GCa) with 18% of Atrophic Gastritis cases progressing to cancer within 10 years. By targeting endoscopy resources towards those patients with the greatest risk experts agree that it is possible to diagnose diseases sooner, deliver major improvements in survival in a cost-effective way, and help reach the desired quality standards in endoscopy.

Diagnosing Atrophic Gastritis in Primary Care

The GastroPanel® blood test is a laboratory assay that accurately identifies Atrophic Gastritis from a plasma sample by measuring four stomach-specific biomarkers. GastroPanel® is a first-line diagnostic test for adults with dyspepsia in Primary Care and importantly, it fits seamlessly into existing pathways for dyspepsia. GastroPanel® overcomes the limitations of stand-alone Helicobacter pylori tests too by enabling the physician to exclude, or, make a diagnosis of Atrophic Gastritis which would otherwise only be possible via invasive gastroscopy. This extra information is valuable for patient management, helping GPs with decisions such as whether to refer the patient, and making better use of available healthcare resources. GastroPanel® is non-invasive, low-cost and extensively validated, and can help physicians select and prioritise Gastroscopy for patients who need it.

How does GastroPanel change day to day management of dyspepsia?

When patients present with dyspepsia the symptoms are often non-specific, making the diagnosis very difficult and heavily reliant on family history, lifestyle and clinical assessment. GastroPanel® is a very effective tool that provides details about the structure and function of the gastric mucosa, and identifies high-risk Atrophic Gastritis without the need for gastroscopy. By using GastroPanel® first, the GP and patient are presented with three options to consider, directed by a simple algorithm - Manage in Primary Care, Treat, or Refer for Endoscopy.

Request the GastroPanel® blood test for patients with symptoms of dyspepsia and receive a risk assessment and accurate profile of your patient’s stomach health, before referral for gastroscopy.

The test panel consists of four assays:

  • Pepsinogen I ELISA
  • Pepsinogen II ELISA
  • Gastrin-17 ELISA
  • Helicobacter pylori IgG ELISA
Use GastroPanel® to: 
  • Reliably detect high-risk atrophic gastritis and H. pylori infection;
  • Find patients with hypochlorhydric (low acid) stomach;
  • Identify and refer patients who need gastroscopy;
  • Find patients with a healthy gastric mucosa.
Risks associated with atrophic gastritis:
  • Gastric cancer (sequel to corpus and/or antral atrophy); 
  • Achlorhydria or Hypochlorhydria;
  • Malabsorption of vitamin B12, calcium, magnesium, zinc, iron and some medicines (corpus atrophy);
  • Colonisation of the stomach by microbes.
Helicobacter pylori infection is an independent risk factor for both gastric cancer and peptic ulcer disease.For more information about the GastroPanel, please visit www.gastropanel.com
 
 

Clinical background

GastroPanel® is a simple laboratory examination performed on a blood sample. It gives diagnosis, for example, of healthy stomach mucosa, Helicobacter pylori (H.pylori) infection and atrophic gastritis. Based on the results, functional dyspepsia can be differentiated from organic dyspepsia. The results also give important information on possible risks related to H.pylori infection, atrophic gastritis and high acid production. GastroPanel examination promotes evidence-based medicine.

H.pylori infection is diagnosed by an antibody test. Pepsinogen I, pepsinogen II and gastrin-17 levels describe the structure and function of the whole gastric mucosa. The more severe is the atrophic gastritis in the corpus mucosa, the lower is the level of pepsinogen I, and the ratio of pepsinogenI/II in blood. The more severe is the atrophic gastritis of antrum mucosa, the lower is the the level of gastrin-17 in blood. On page Interpretation of the results you will find a more detailed explanation on how GastroPanel® results are interpreted.

GastroPanel® gives a reliable diagnosis of:

Healthy stomach mucosa. When the stomach mucosa is healthy, the reason for stomach problems is most likely to be functional dyspepsia or disease outside the stomach.

  • H.pylori infection.
  • Atrophic gastritis (severely damaged and dysfunctional stomach mucosa) and the condition, specifically, of the corpus and antrum mucosa (normal, gastritis or atrophic gastritis)

Test results and diagnosis

Reference ranges and explanation on values outside them
Recommendations for further testin/treatment (e.g. gastroscopy and biopsy examination, H.pylori eradication treatment) that the doctor in charge decides on.
GastroPanel® is well suited for follow-up of the success of treatment for H.pylori eradication treatment and atrophic gastritis, as well as for their diagnosis. Furthermore, Gastrin-17 level indicates whether the patient may has hyperacidic stomach, and a resulting risk of gastroesophageal reflux disease (GERD) and its complications. GastroPanel can therefore be used to determine whether a patient really needs e.g. commonly described PPI (proton pump inhibitor) medication. If a patient has atrophic gastritis in the corpus, the stomach is hypoacidic, and there is no need for PPIs; if the stomach is hyperacidic, the situation is different.

Atrophic gastritis diagnosis vs. histology N=404

GastroPanel
Accuracy 83%
Sensitivity 83%
Spesificity 95%
Positive Predictive Value 75%
negative Predictive Value 97%

Table 1. In a Finnish multicenter study with 404 dyspepsia patients as participants, the performance of GastroPanel was compared to histology. GastroPanel examination diagnosed healthy stomach mucosa nearly as reliably as gastroscopy and biopsy examination. For atrophic gastritis, the accuracy was excellent (81%) compared to histological study (Väänänen et al. Eur J Gastroenterol Hepatol 2003; 15:885-891).

Ordering


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