An evaluation of a serologic test with a current infection marker of Helicobacter pylori before and after eradication therapy in Chinese.
OBJECTIVE
Development of an accurate and less cumbersome noninvasive method to detect current Helicobacter pylori infection is essential in clinic. The aim of this study was to evaluate the performance of the CIM test, also known as the Assure H. pylori Rapid Test (Genelabs Diagnostics Pty. Ltd., Singapore), for the diagnosis of current H. pylori infection before and after eradication therapy in Chinese population.


METHODS
A total of 452 eligible people were recruited for this study in Jiangsu Province, China. Each individual underwent a 13C urea breath test (13C-UBT). For the evaluation of CIM test after eradication, 115 H. pylori-positive outpatients were treated with 1-week triple therapy. One month after the end of therapy, the patients underwent 13C-UBT again, and the CIM-test was performed 1, 3, and 6 months after the end of therapy. Its performance (sensitivity, specificity, positive and negative predictive values, and accuracy) were determined using the 13C-UBT as a gold standard for H. pylori diagnosis.


RESULTS
H. pylori was detected in 221 (65.6%) of the 337 people by 13C-UBT. The sensitivity, specificity, positive and negative predictive values, and accuracy of the CIM test were 93.2%, 90.5%, 94.9%, 87.5%, and 92.3%, respectively, using 13C-UBT as a gold standard. One month after eradication therapy, the sensitivity, specificity of CIM test were only 50% and 66.7%, 66.7% and 84.6% 3-month after eradication therapy and the sensitivity, specificity increased to 85.7% and 96.9%, respectively, when CIM test was used 6 months after the end of anti-H. pylori therapy.


CONCLUSIONS
The CIM test is a simple, rapid, accurate, cheap, and near-people test. It may be satisfactory for detecting H. pylori infection in cases without eradication therapy, but it could not differentiate the past or current infection correctly within 6 months after anti-H. pylori therapy.
Wang
Xiao Yong
XY
Department of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Yang
Yang
Y
Shi
Rui Hua
RH
Ho
Bo
B
Wang
Hong Di
HD
Zhang
Guo Xin
GX
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D001944:Breath Tests; D002648:Child; D002681:China; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000188:drug therapy; D016480:Helicobacter pylori / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods; D014508:Urea / Q000032:analysis
D000900:Anti-Bacterial Agents; D011933:Reagent Kits, Diagnostic; D014508:Urea