Reliability of two commercial serological kits for serodiagnosing Helicobacter pylori infection.
Two commercial serological kits, Pylori-set (Orion Diagnostica, Finland) and Helico-G (Cambridge Biomedical Ltd, UK), and an in-house ELISA were evaluated with sera from 24 Helicobacter pylori-positive and 146 H. pylori-negative dyspeptic patients. Sensitivity, specificity, positive and negative predictive values of Pylori-set were lower than that of Helico-G and in-house ELISA. Helico-G was more sensitive (91.7%) than in-house ELISA (83.3%) and both had comparable negative predictive values of 98.3% and 97.3%, respectively. However, specificity (97.9%) and positive predictive value (86.9%) of an in-house ELISA were much higher than specificity (80.1%) and positive predictive value (43.1%) of Helico-G. Kappa index of agreement between the three serological tests (Pylori-set, Helico-G or in-house ELISA) and the presence of H. pylori in antral biopsies was very low (k = 0.13; z = 1.9; p > 0.05), moderate (k = 0.49; z = 7.1; p < 0.0001), or substantial (k = 0.82; z = 10.8; p < 0.0001), respectively. Overall, statistical evaluations demonstrated that both commercial kits were not as reliable as the in-house ELISA for serodiagnosing H. pylori infection.
Department of Microbiology and Parasitology, School of Medical Sciences, Universiti Sains Malaysia.
A M
AM
Uyub
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AK
Anuar
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Aiyar
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000097:blood; D001706:Biopsy; D004415:Dyspepsia / Q000175:diagnosis; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000276:immunology / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D011706:Pyloric Antrum / Q000382:microbiology / Q000473:pathology; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000295:instrumentation
D000907:Antibodies, Bacterial; D011933:Reagent Kits, Diagnostic