Review Article

Diagnostic Methods of Helicobacter pylori Infection for Epidemiological Studies: Critical Importance of Indirect Test Validation

Table 6

Diagnostic test for H. pylori infection.

Diagnostic testSensitivity 
[18, 21]
Specificity 
[18, 21]
AdvantagesDisadvantages

Direct test
Histology95%99%High accuracy, a possibility to send specimens at room temperature, and combination with IHC increase accuracy.Low sensitivity for patients with gastric atrophy or intestinal metaplasia, time and cost, dependent on the operator skills, and interobserver variability.
Culture69–98%100%Direct detection of H. pylori, excellent specificity, and allowing determination of antibiotic sensitivities.Limited sensitivity, time-consuming procedure, and need of a special transport.
RUT90%93%Inexpensive and provides rapid results, adding the number and increasing the size of biopsy specimens will increase the accuracy.Sensitivity significantly reduced by bismuth, PPI and antibiotics, and formalin contamination of biopsy forceps generate false negative.

Indirect test
UBT95%95%Higher accuracy than serology and SAT, having a new portable type.Atrophy, bismuth, PPI and antibiotics induce false-negative and need a local validation.
SAT94%92%More economical than UBT and monoclonal antibody showed better accuracy.Differences in the antigens may affect the accuracy, influence by bismuth, PPI, and antibiotics, and accuracy was influenced by stool condition.
Serology90%80%Inexpensive, widely available, and the most efficient method in particular condition.Less accurate than UBT and SAT and the cut-off values should be validated locally and cannot distinguish between current and past infections.

PPI: proton pump inhibitor; UBT: urea breath test; SAT: stool antigen test; RUT: rapid urease test.