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Clinical and Diagnostic Laboratory Immunology, July 2004, p. 775-779, Vol. 11, No. 4
1071-412X/04/$08.00+0     DOI: 10.1128/CDLI.11.4.775-779.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Use of a Novel Enzyme Immunoassay Based on Detection of Circulating Antigen in Serum for Diagnosis of Helicobacter pylori Infection

Abdelfattah M. Attallah,1* Hisham Ismail,1 Gellan G. Ibrahim,1 Mohamed Abdel-Raouf,2 Ahmed M. El-Waseef,1,3 and Mohamed Abdel-Wahab2

Research & Development Department, Biotechnology Research Center, New Damietta,1 Gastro-Enterology Center, and,2 Chemistry Department, Faculty of Science, Mansoura University, Mansoura, Egypt3

Received 27 July 2003/ Returned for modification 20 January 2004/ Accepted 15 March 2004

Recently, noninvasive diagnostic tests for Helicobacter pylori infection have gained in significance. We have developed a sensitive and specific noninvasive immunoassay based on the detection of an H. pylori circulating antigen (HpCA) in sera from H. pylori-infected individuals. Monospecific antibody and Western blot analyses were used to demonstrate the presence of the target antigen in H. pylori cell lysate and serum samples. A novel enzyme-linked immunosorbent assay (ELISA) was developed for the detection of HpCA in serum. Endoscopic biopsy specimens from the gastric antra of 221 individuals (143 males and 78 females) with dyspeptic symptoms were evaluated for H. pylori infection, with culture used as a "gold standard" for diagnosis. The target H. pylori antigen was identified at 58 kDa. HpCA has been detected by ELISA with high degrees of sensitivity, specificity, and efficiency (>90%), and ELISA results show no significant difference (P > 0.05) from results of H. pylori culture of gastric biopsy specimens. The test's positive and negative predictive values were also high (95 and 86%, respectively). In conclusion, a sensitive and specific immunoassay was developed for the detection of HpCA in human serum. This test can be applied for noninvasive laboratory and field diagnoses of H. pylori infection.

* Corresponding author. Mailing address: Biotechnology Research Center, P.O. Box (14), New Damietta City, Egypt. Phone: (02) (057) (402889). Fax: (02) (057) (401889). E-mail: amattallah{at}hotmail.com.

Clinical and Diagnostic Laboratory Immunology, July 2004, p. 775-779, Vol. 11, No. 4
1071-412X/04/$08.00+0     DOI: 10.1128/CDLI.11.4.775-779.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.





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