Evaluation of the monoclonal stool antigen test for Helicobacter pylori in an Asian population with dyspepsia.
OBJECTIVE
Although well established in the West, stool antigen tests (SAT) are not widely used in Asia. Data on the accuracy of this test in Asia is sparse and, to date, there have been no studies looking at the more refined monoclonal SAT. The aim of this study is to validate the diagnostic accuracy of a stool antigen test, Hp STAR, for the detection of Helicobacter pylori.


METHODS
Consecutive new patients with dyspepsia, referred to the endoscopy unit were recruited. At endoscopy, biopsies were taken for rapid urease tests and histology. Stool specimens were collected before any therapy was given and were tested for H. pylori using the monoclonal SAT HpSTAR test. Samples were collected from 90 patients. The stool antigen results were compared with the results of rapid urease tests and histopathology, which were used together as the gold standard test in the diagnosis of H. pylori.


RESULTS
Of the 90 patients tested, 45 were H. pylori positive and 45 were H. pylori negative. There was one false positive and one false negative test. The sensitivity, specificity, positive predictive value and negative predictive value for the Hp STAR were identical: 97.8% with a 95% confidence interval of 88.2-99.9%. The diagnostic accuracy was 97.8% with a 95% confidence interval of 92.2-99.7%.


CONCLUSIONS
The monoclonal stool antigen test, HpSTAR is a highly accurate test for the diagnosis of H. pylori.
Bhewa
Yusuf
Y
Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Hilmi
Ida
I
Cheah
Phaik-Leng
PL
Navaratnam
Parasakthi
P
Goh
Khean-Lee
KL
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal; D000942:Antigens, Bacterial / Q000032:analysis*; D044466:Asian People; D004415:Dyspepsia / Q000209:etiology / Q000382:microbiology* / Q000473:pathology; D016099:Endoscopy, Gastrointestinal; D005243:Feces / Q000382:microbiology*; D005260:Female; D005753:Gastric Mucosa / Q000473:pathology; D016481:Helicobacter Infections / Q000150:complications / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012680:Sensitivity and Specificity
D000911:Antibodies, Monoclonal; D000942:Antigens, Bacterial