Validation of a new serologic test for the detection of Helicobacter pylori

In order to determine normal ranges for positive and negative titres using a new commercially available second generation serologic ELISA test for the detection of Helicobacter pylori IgG antibodies (Malakit® by Biolab, Limal, Belgium) we investigated 560 asymptomatic pregnant women aged 20 to 44. 128 patients (22.9%) had a positive titre for Helicobacter pylori. Although we were able to observe an increase of the number of seropositive subjects with advancing age, a significant increase in titre with age, both for positive and negative titres, could not be demonstrated. Although there was a much higher prevalence of Helicobacter pylori seropositivity in patients with a non-caucasian ethnic background, we did not observe a significant difference in cut-off limit between the different ethnic populations. In all seropositive patients a control serology and ¹³C-urea breath test were performed 4 to 6 months later. In 124 patients (96.9%) both control examinations were positive. The positivity of the ¹³C-urea breath test suggests an existent Helicobacter pylori infection in these (symptom-free) women. ¹³C-urea breath tests were also performed in 100 randomly selected seronegative women and were all negative, as well. Since ¹³C-urea breath tests were positive in seropositive subjects and negative in seronegative women, we validated the manufacturer's previously established cut-off values, based on only 37 adult patients, in a much larger population.