Evaluation of a New Latex Agglutination Immunoturbidimetry Kit, H. pylori—Latex “SEIKEN”, for the Detection of Anti—H. pylori Antibody in the Blood 1189

• Published in: The American journal of gastroenterology Vol. 113; no. Supplement; p. S678
• Main Authors: Kodama, Masaaki, Okimoto, Tadayoshi, Mizukami, Kazuhiro, Ogawa, Ryo, Okamoto, Kazuhisa, Fukuda, Kensuke, Matsunari, Osamu, Murakami, Kazunari
• Format: Journal Article
• Language: English
• Published: New York Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins 01.10.2018
• Subjects: Antibodies; Endoscopy; Gastroenterology; Infections; Japan
• ISSN: 0002-9270; 1572-0241
• DOI: 10.14309/00000434-201810001-01189

Introduction: Both the presence and past H. pylori (HP) infection have the risk for gastric cancer, therefore, it is necessary for the patients after eradication to be diagnosed exactly. The test of anti- HP antibody in the blood can detect not only present infection, but also past HP infection. In this study, we evaluated basic performance of the new anti-H. pylori antibody detection kit, HP -Latex SEIKEN (Denka kit) (Denka Seiken Co., Ltd) by the comparison with the other antibody methods. Methods: A total of 187 patients were enrolled to the study. 77 patients were positive for HPinfectionin all of the endoscopic atrophy, rapid urease test (RUT) and culture method.75 patients were negative for HP infection in all of them. 35 patients observed endoscopic atrophy, however, they were negative for both RUT and culture test. These 35 patients were suspected to have past HP infection. As a gold standard for the detection of HP infection, we used endoscopic atrophy, RUT and culture method. All subjects were evaluated with 4 type of anti-H. pylori antibody detection kit, that is Denka kit (Latex method, Denka seiken co., ltd., Tokyo, Japan), E plate, Eiken, (Kit A, ELISA, Eiken Chemical co.,ltd., Tokyo, Japan), PREMIER H.PYLORI (Kit B, ELISA, Meridian Bioscience, Inc., Ohio, USA), PLATERIA™ H. PYLORI IgG (Kit C, ELISA, Bio-Rad, Marnes-la-Coquette, France). Results: When 35 samples which were considered as past infection were excluded, the sensitivity, specificity and accuracy of Denka kit were 92.2%, 93.3%, 92.8%, those of kit A were 88.3%, 100/0%, 94.1%, those of kit B were 98.7%, 76.0%, 87.5%, and those of kit C were 98.7%, 80.0%, 89.5%, respectively. In Denka Kit, all of sensitivity, specificity, accuracy exceeded 90%, but Kit A performed specialization 100% in specificity. In 35 samples with past infection, 48.6% (17/35) showed the positive result of Denka kit, and showed 17.1% (6/35) showed the positive result in Kit A. Both Kit B and Kit C showed 54.3% (19/35) positive result in the past infection samples, these results were affected by the low cutoff value of kit B and C. Denka kit (with LATEX method) showed significantly higher sensitivity than kit B (with ELISA method) which is most frequently used in Japan. Conclusion: A new anti-H. pylori IgG antibody Latex kit for H. pylori diagnosis (Denka kit) showed high sensitivity and specificity. This kit is a useful and reliable diagnostic method even for patients with past H. pylori infection.