Advantage of using a home-made elisa kit for detection of Helicobacter pylori infection over commercially imported kits

• Published in: Indian journal of medical microbiology 2008-04, Vol.26 (2), p.127-131
• Main Authors: Mohammadi, M, Talebkhan, Y, Khalili, G, Mahboudi, F, Massarrat, S, Zamaninia, L, Oghalaei, A
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Antigens, Bacterial - blood; Autoimmune diseases; Bacteria; Biopsy; Cancer; Enzyme-Linked Immunosorbent Assay - economics; Enzyme-Linked Immunosorbent Assay - methods; Female; Helicobacter Infections - diagnosis; Helicobacter pylori - isolation & purification; Helicobacter pylori, IgG ELISA, serology, screening; Histology; Humans; Male; Middle Aged; Older people; Sensitivity and Specificity
• ISSN: 0255-0857; 1998-3646
• DOI: 10.4103/0255-0857.40525

Purpose: To evaluate a home-made ELISA kit for detection of Helicobacter pylori (Hp) infection and comparison of its immunologic criteria with those of foreign commercial kits. Methods: A home-made IgG ELISA kit was developed using soluble antigenic fractions of Hp proteins. Confirmed sera were tested and serological criteria were evaluated through assessment of 199 serum samples. Results: The accuracy, sensitivity and specificity values of home-made kit were 92, 92 and 90.4%, respectively. These immunologic criteria for Trinity kit were 95.2, 95.2 and 95% in comparison with IBL kit (91.3, 92.2 and 88.5%), BIOHIT kit (72.4, 41.6 and 94.1%) and HelicoBlot2.1 (94.2, 93.4 and 100%). Kappa agreement assessment demonstrated that two of the imported ELISA kits had fair to moderate agreement with the home-made kit while the other one had a poor agreement value. Conclusions: Apart from comparable values between the home-made kit and the most efficient imported kit (Trinity) there was significant cost benefit. Therefore, we recommend the home-made kit as a suitable substitution for detection of Hp infection in the Iranian population.