Abstract
Background and Aim: Helicobacter pylori (H. pylori) infection is the most important risk factor for gastric cancer (GC). In Japan, the serum anti-H. pylori antibody test is widely used for the diagnosis of H. pylori infection. The aim of this study was to analyze the value of a commercially available serum anti-H. pylori antibody diagnostic kit, H. pylori-LATEX “SEIKEN” (Denka Ltx), in GC risk stratification.
Method: A total of 902 subjects, who underwent Esophagogastroduodenoscopy (EGD) within a year, were analyzed.
Using endoscopic submucosal dissection(ESD) - based diagnosis for H. pylori infection, the sensitivity, specificity, match rate, and Kappa coefficient of two serum anti-H. pylori antibody reagents (Denka Ltx and Eiken E-plate) were evaluated.
The EGD-based diagnostic criteria for H. pylori infection are as follows:
I) If the atrophic pattern is C-2, C-3, O-1, O-2, or O-3, H. pylori infection status is positive
II) If the atrophic pattern is C-0, H. pylori infection status is negative
in accordance with the “Kimura-Takemoto Classification”.
Next, 5280 subjects who underwent EGD within five years were analyzed. They were divided into groups based on the H. pylori infection status and ABC classification (from A to D). The incidence rate (IR) and accumulate incidence rate (AIR) of GC were analyzed using log-rank test with Kaplan-Meier curves.
Result: The sensitivity, specificity, match rate, and Kappa coefficient of the E-plate were 91.9%, 93.8%, 93.2%, and 0.840, respectively; those of the Denka Ltx were 87.6%, 93.8%, 91.9%, and 0.808, respectively. The Kappa coefficient for the two reagents was 0.906. IR and AIR were 0/3354(0%) and 0% in H. pylori-positive subjects, and 13/1926(0.67%) and 1.41% in H. pylori-negative subjects, respectively. In the groups A, B, C, and D, the IR and AIR were 0/3319(0%) and 0% for group A, 4/1281(0.31%) and 0.45% for group B, 9/645(1.40%) and 3.55% for group C, and 0/35(0%) and 0% for group D, respectively. Comparisons between H. pylori-positive and H. pylori-negative subjects and among groups A, B, C, and D showed statistical significance (P<0.0001).
Conclusion: In comparison to the E-plate, the Denka Ltx showed a sufficiently accurate diagnostic rate. The GC incident risk was efficiently stratified using the ABC classification system based on the Denka Ltx. These findings showed that Denka Ltx is useful for GC risk prediction.
