Point-of-care Helicobacter pylori testing: primary care technology update

BACKGROUND AND ADVANTAGES OVER EXISTING TECHNOLOGY

Helicobacter pylori (HP) infection causes approximately 5% of uninvestigated dyspepsia and a 20% lifetime risk of peptic ulcer disease.¹ HP is a grade 1 carcinogen: 5.2% of cancers globally are attributable to HP infection.² HP eradication results in: reduced gastric cancer incidence; prevention of recurrent duodenal (number needed to treat [NNT] = 2) and stomach (NNT = 3) ulceration; and resolution of dyspepsia (NNT = 13).³

Non-invasive Helicobacter pylori diagnostic tests are available for point-of-care (POC) use in primary care and include IgG serology, ¹³C-urea breath test (UBT), and monoclonal stool antigen. Only UBT is sufficiently accurate to confirm current infection or eradication.⁴ HP IgG serology cannot differentiate current from past infection. Rapid qualitative stool antigen testing currently lacks diagnostic accuracy.

DETAILS OF TECHNOLOGY

Isotope ratio mass spectrometry (IRMS) is the most commonly used ¹³C-UBT method in the UK. However, the sampling procedure involves many opportunities for test incompletion: collection of the test from the pharmacy; returning for a subsequent extended appointment; sending the test to the laboratory; and awaiting results. In comparison, non-dispersive isotope selective infrared spectroscopy (NDIRS) has potential as a POC device: it can be used by non-specialist staff outside the laboratory setting, it …