Highly Sensitive Urine‐Based Enzyme‐Linked Immunosorbent Assay for Detection of Antibody to Helicobacter pylori

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Abstract
Background. Enzyme‐linked immunosorbent assay (ELISA) has been widely used for detection of Helicobacter pylori (H. pylori), but sample collection is often invasive, complicated, and expensive. Urine samples can be obtained noninvasively and are easier and safer to handle than serum samples. A urine‐based ELISA, if found to be accurate, would therefore be a useful alternative to serum‐based tests for H. pylori. Methods. An ELISA method was developed for detection of antibodies to H. pylori in urine. Its sensitivity and specificity were compared with those of three commercially available serum‐based ELISA kits and the 13C urea breath test (13C‐UBT) using samples from 99 healthy volunteers and 20 patients with gastric disorders. Results. With the assumption that 13C‐UBT results are 100% accurate, the sensitivity and specificity of the urinary ELISA were 99% and 100%, respectively, and the accuracy (99%) was superior to those of the three serum ELISAs tested. Immunostaining profiles on Western blot analysis using serum samples were almost identical to those obtained using paired urine samples. Conclusions. These findings suggest that the differences observed among ELISA test results may be due principally to differences between the profiles of antigen coated on plates for the assays, rather than to differences between antibodies in serum and urine. The urine‐based ELISA (URINELISA H. pylori) developed in this study is very accurate and would be useful for screening H. pylori infection as an alternative to serum ELISAs.