PT  - JOURNAL ARTICLE
AU  - Wilcox, M H
AU  - Dent, T H
AU  - Hunter, J O
AU  - Gray, J J
AU  - Brown, D F
AU  - Wight, D G
AU  - Wraight, E P
TI  - Accuracy of serology for the diagnosis of Helicobacter pylori infection--a comparison of eight kits.
AID  - 10.1136/jcp.49.5.373
DP  - 1996 May 01
TA  - Journal of Clinical Pathology
PG  - 373--376
VI  - 49
IP  - 5
4099  - http://jcp.bmj.com/content/49/5/373.short
4100  - http://jcp.bmj.com/content/49/5/373.full
SO  - J Clin Pathol1996 May 01; 49
AB  - AIMS: To determine the accuracy of eight commercially available kits for the serological diagnosis of Helicobacter pylori infection, and hence whether a serology service could be introduced to reduce endoscopy workload. METHODS: Eighty four patients newly presenting to their general practitioners with dyspepsia were recruited. Gold standard diagnosis of H pylori infection was obtained both by a histological examination of gastroduodenal biopsy specimens and by the 14C-urea breath test (UBT). The performance of six quantitative and two qualitative enzyme linked immunosorbent assays for H pylori IgG, used according to the manufacturers' instructions, with serum samples obtained during the endoscopy visit, were compared. RESULTS: The study population had a median age of 45 years, and the prevalence of H pylori infection was 35%. With one exception, where the patient had received a course of anti-H pylori treatment between endoscopy and UBT, there was 100% concordance in the results of the two gold standard techniques. Discordant serology results were more common in patients aged > 50 years (42% of the total) than in younger patients (21%), and this was most noticeable in uninfected patients. The sensitivity of the kits was good (90-100%), but specificity was more variable (76-96%), and the rate of equivocal results was unacceptably high in some cases (0-12%). The overall accuracy of the kits ranged from 83 to 98%. Two kits in particular performed well (Pylori-Elisa II, Bio-Whitaker and Premier, Launch; qualitative) with 98% and 100% accuracy, respectively. CONCLUSIONS: In a symptomatic population with a prevalence of H pylori infection of 35%, particularly in patients aged < 50 years, some but not all serology kits may be used as a highly accurate and inexpensive alternative to the gold standard techniques.