Study designs of evaluations included in the review
Inclusion criteria were not defined in terms of the study design. Details of the designs of the included studies were not provided.
Specific interventions included in the review
Studies that evaluated the monoclonal SAT for the diagnosis of H. pylori infection were eligible for inclusion. Studies that used ‘in-office’ or ‘rapid’ stool tests were excluded.
Reference standard test against which the new test was compared
Studies had to use at least one independent diagnostic method to determine the true status of H. pylori infection to be included in the review. The specific reference standards used in the included studies were rapid urease test, histology, culture, urea breath test and serology, either alone or in combination.
Participants included in the review
Inclusion criteria were not defined in terms of the participants, although studies of patients with specific conditions such as end-stage renal disease, cirrhosis or partial gastrectomy were excluded. Studies of both adults and children were included.
Outcomes assessed in the review
Inclusion criteria were not defined in terms of the outcomes, but it appears that studies had to report sufficient data to construct a 2x2 table of test performance. The outcomes reported in the review were the sensitivity, specificity, and positive and negative likelihood ratios (LR+ and LR-, respectively).
How were decisions on the relevance of primary studies made?
The authors did not state how the papers were selected for the review, or how many reviewers performed the selection.