Quality statement 3: Testing conditions for Helicobacter pylori

Quality statement

Adults with dyspepsia or reflux symptoms have a 2‑week washout period before a test for Helicobacter pylori if they are receiving proton pump inhibitor therapy.

Rationale

To improve the accuracy of Helicobacter pylori (H pylori) testing it is important to have a 2‑week washout period after using a proton pump inhibitor (PPI). Improving the accuracy of the test will ensure that treatment for H pylori infection is given only if needed. Treatment for H pylori infection is complex and there is concern that treatment without an accurate diagnosis may lead to increasing antimicrobial resistance. In addition, treatment for H pylori can be unpleasant for the patient and has an increased risk of antibiotic‑associated diarrhoea and enteric infections such as Clostridium difficile.

Quality measures

Structure

Evidence of local arrangements to ensure that adults with dyspepsia or reflux symptoms have a 2‑week washout period before a test for H pylori if they are receiving PPI therapy.

Data source: Local data collection.

Process

Proportion of adults with dyspepsia or reflux symptoms receiving PPI therapy who are tested for H pylori who had a 2‑week washout period before the test.

Numerator – the number in the denominator who had a 2‑week washout period before the test.

Denominator – the number of adults with dyspepsia or reflux symptoms receiving PPI therapy who are tested for H pylori.

Data source: Local data collection.

Outcome

H pylori antimicrobial resistance rate.

Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (general practices and hospitals) ensure that adults with dyspepsia or reflux symptoms have a 2‑week washout period before a test for H pylori if they are receiving PPI therapy.

Healthcare professionals ensure that adults with dyspepsia or reflux symptoms have a 2‑week washout period before testing for H pylori if they are receiving PPI therapy.

Commissioners (clinical commissioning groups and NHS England area teams) commission services that ensure that adults with dyspepsia or reflux symptoms have a 2‑week washout period before a test for H pylori if they are receiving PPI therapy.

What the quality statement means for patients, service users and carers

Adults with indigestion or heartburn may need to have a test for an infection called Helicobacter pylori (H pylori for short), which can cause stomach and duodenal ulcers (the duodenum is the section of intestine immediately after the stomach). H pylori infection is detected using a breath or stool test, or sometimes a blood test. If the person is taking a medicine called a proton pump inhibitor (PPI) for their indigestion or heartburn symptoms, their GP will tell them if they need to stop taking the PPI or any other medicine before the H pylori test.

Source guidance

Definitions of terms used in this quality statement

Proton pump inhibitor (PPI)

Proton pump inhibitors inhibit gastric acid secretion by blocking the hydrogen‑potassium adenosine triphosphatase enzyme system (the 'proton pump') of the gastric parietal cell. PPIs include esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole.

[British National Formulary section 1.3.5 Proton pump inhibitors]

Test for H pylori

Use a carbon‑13 urea breath test, a stool antigen test or laboratory‑based serology where its performance has been locally validated to test for H pylori. Ensure that no antibiotics have been taken for any infection in the 4 weeks before the test.

If laboratory‑based serology is to be used, its performance should be locally validated to test for H pylori. The serology test should have high positive predictive value in the intended population, or positives should be confirmed with a second test. Validation is an evidence‑based assessment of how a test performs in the laboratory, and demonstrates suitability for intended purpose. Local validation will provide documentary evidence that a commercial serology kit is performing within the manufacturer's specifications. This will include results of experiments to determine its accuracy, sensitivity, reliability and reproducibility. Local validation should meet the requirements set out in the UK Standards for Microbiology Investigations.

[Adapted from Dyspepsia and gastro-oesophageal reflux disease (2014) NICE guideline CG184 recommendations 1.4.2 and 1.9.1, UK Standards for Microbiology Investigations – SMI Q1: Commercial and in-house diagnostic tests: evaluations and validations (2014) Public Health England Quality Guidance, and expert opinion]

Equality and diversity considerations

Serological tests are less reliable in older people and therefore, where laboratory‑based serology tests are used, their suitability for people over 65 should be carefully considered.

It is important to use an accurate test for H pylori for people from ethnic minority groups because resistance rates are higher than in the general population. Where laboratory‑based serology tests are used, their suitability for people from ethnic minority groups should be carefully considered.