Non-invasive diagnosis of Helicobacter pylori infection in adult dyspeptic patients by stool antigen detection: does the rapid immunochromatography test provide a reliable alternative to conventional ELISA kits?

Abstract

Stool antigen-testing allows non-invasive detection of Helicobacter pylori that is indicative of active infection. Three commercial kits are currently marketed in the UK for stool antigen-testing. The aim of this study was to conduct a comparative evaluation of the performances of each of these tests, compared with culture and histological examination of gastric biopsies, for pre-treatment diagnosis of infection in an adult dyspeptic population in south-east England. Examination of 112 stool samples by the Premier Platinum HpSA ELISA (Meridian Diagnostics) and by the Amplified IDEIA HpStAR ELISA (DakoCytomation) kits demonstrated that the latter was more sensitive (81 . 3 versus 93 . 8 %, respectively) and specific (91 . 7 versus 100 . 0 %, respectively). Additionally, the IDEIA HpStAR was easier to interpret, with OD readings of positive and negative results being far from the recommended cut-off, whereas equivocal results that were generated by the HpSA kit were difficult to interpret. Additional testing of 87 of the 112 stools by the ImmunoCard STAT! HpSA kit (Meridian Diagnostics) demonstrated that this test was easier to perform than ELISA and was more sensitive than the HpSA kit but, compared with the IDEIA HpStAR kit, the ImmunoCard test was less sensitive (87 . 8 versus 95 . 9 %, respectively) and specific (89 . 4 versus 100 . 0 %, respectively). Furthermore, the ImmunoCard test generated weakly positive results, correlating with lower OD readings for both ELISA kits, that were difficult to interpret. The Amplified IDEIA HpStAR kit is therefore the most sensitive and specific of the three tests that are available for pre-treatment, non-invasive detection of H. pylori in stool samples in an English adult dyspeptic population.

Comparison of stool antigen and urea breath test (UBT) methods for detection of Helicobacter pylori infection and the risk factors

“…We also found that the positive H. pylori infection which detected by stool antigen test was seen in 48% patients which is lower than Chisholm SA et al [15,16] and Gisberg JP [17], this was due to more antigens present in stool in above study and they have more advance than us in diagnostic methods. Our study showed lower number of positive cases which may be due to insufficient amount of antigen in the stools.…”

Diagnosis of Helicobacter pylori Infection

“…For this reason a monoclonal antibody is used in other kits such as the HpStAR (Dako, Glostrup, Denmark) (or Femtolab, Connex, Martinsried, Germany) and the results show a better accuracy. In addition, the ODs are clearly different between positive and negative specimens for the latter in contrast to the former that facilitates the interpretation [59]. Monoclonal antibodies are also used in an immunochromatographic test which can be performed in the ward as a doctor test (Immuno Card STAT!…”

Evaluation of a Rapid New Stool Antigen Test for Diagnosis of Helicobacter pylori Infection in Adult Patients

“…While the value of enzyme immunoassays (EIAs) using either polyclonal or monoclonal antibodies is well documented, the sporadic existing data for the first developed and commercially available rapid test (ImmunoCard STAT! HpSA) showed enormous differences among the studies (1,7,8,14,17), and its reliability is reported to be somewhat lower than that of monoclonal fecal antigen EIA (2,9).…”