There is increasing interest in noninvasive tests for the diagnosis of Helicobacter pylori (H. pylori) infection. One such test, a urine-based rapid test kit (RAPIRUN H. pylori Antibody, Otsuka Pharmaceutical Co., Ltd.) for detection of antibody to H. pylori, has been developed and is considered ideal. In addition to its noninvasiveness and safe handling-due to use of urine as a sample-the assay procedure used for the urinary rapid test is very simple. Only 10-20 minutes are required to complete an assay, and no instruments are needed. The aim of this study was to examine the clinical usefulness of this urine-based rapid test. A total of 189 patients, including 76 patients with gastroduodenal disease, were recruited. A pair of random single-void urine and serum samples was collected from each of the 189 patients, and antibody to H. pylori in the urine and serum samples was measured using the urine-based rapid test kit and three commercially available serum-based ELISA kits. For the patients with gastroduodenal disease, invasive diagnostic methods using endoscopic biopsy specimens such as culture, histology, and rapid urease test were also performed. The sensitivity, specificity, and accuracy of the urinary rapid test were evaluated on the basis of the three serum ELISA results or the invasive diagnostic results. In addition, various urinalyses were performed, and the effects of substances existing in urine on the urinary rapid test results were examined. Of the 189 patients, the urinary rapid test was positive for 110 (58.2%), negative for 78 (41.3%), and invalid for only one patient (0.5%). Based on the three serum-based ELISA results, the sensitivity, specificity, and accuracy of the urinary rapid test were 93.7, 88.9, and 92.2%, respectively. On the basis of the biopsy-based test results, the sensitivity of the urinary rapid test was 100% and its accuracy (95.2%) was equivalent or superior to that of each serum-based ELISA. In addition, no significant differences were observed between groups positive and negative on urinary rapid testing in any urinalysis parameter examined. The novel urinary rapid test kit evaluated in this study enables simple, rapid, and accurate diagnosis of H. pylori infection, and is an ideal test method for point-of-care testing.
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The One Step H. pylori Serum and whole blood Rapid Test is a rapid lateral flow, qualitative immunoassay. It is intended for use at point of care facilities to detect the presence of IgG antibodies specific to Helicobacter pylori (H. pylori) in human blood or serum. It provides an aid in the diagnosis of infection by H. pylori.1. 25 H. Pylori Rapid Test deviceseach sealed in a pouch with a dropper pipette2. Wash buffer, 7 ml3. Instruction for use1. Lancet or other blood collection device2. Clock or timerHelicobacter pylori has been associated with a variety of gastrointestinal diseases including gastritis, duodenal and gastric ulcer, non-ulcer dyspepsia, gastric adenocarcinoma and lymphoma. The exact role that H. pylori plays in gastrointestinal disease still needs to be precisely defined and is the subject of ongoing research. However, the prevalence rates for H. pylori infection as demonstrated by histological and bacteriological methods can approach 90% in patients who present clinical symptoms of the gastrointestinal diseases. H. pylori does not appear to invade the bloodstream since no isolates yet have been detected using commercial blood culture methods. H. pylori infections occur in human populations throughout the world. In developed countries, about 50% of the population may have H. pylori infection by the age of 60 years, while only 10-20% of adults in the third decade of life have it. In patients who present clinical symptoms relating to the gastrointestinal tract there are two major methods of investigation: invasive and noninvasive. Invasive methods include culture of gastric biopsy samples, histologic examination of stained biopsy specimens, or direct detection of the urease activity in the biopsy (CLO test). Noninvasive techniques include urea breath tests and serological methods. Serologic tests are employed to detect antibodies as human immune response to H. pylori. Two methods appear to be of great interest regarding their use in H. pylori routine serology, namely the ELISA and the Western immunoblot because they offer the most versatility in regards to immunoglobulin specificity and relative ease of use. This H. pylori Rapid Test detects IgG antibodies specific to H. pylori infection in patient blood or serum. It is a noninvasive method and does not use radioactive isotopes; the assay procedures are easy and do not require professional training; it provides a rapid result. It is a useful on-site aid in the diagnosis of H. pylori infection.This assay is a double antigen chromatographic lateral flow immunoassay. The test strip in the device includes a burgundy-colored conjugate pad containing colloidal gold coupled with H. pylori antigens and nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with H. pylori antigens, and the C line is coated with goat anti-H. pylori antibody. The antigens used in this device are from H. pylori cell lysate. When IgG antibodies specific to H. pylori are present in the specimen, the T line will become a burgundy-colored band. If antibodies to H. pylori are not present or are present below the detectable level, no T line will develop. The C line should always appear as a burgundy-colored band regardless of the presence of antibodies to H. pylori. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred. For additional details please refer to the instructions for use.-Reliable and inexpensive-Convenient and easy-to-understand directions-Clear preparation procedures-Simple and safe specimen collection directions-Comprehensive package of required materials and components-Rapid and accurate test resultsSee H. pylori Rapid Test Product Insert for specific details on preparation, procedures, quality control, and interpretation of test results.The result is positive if both the C line and T line appear, indicating that the IgG antibodies specific to H. pylori are detected. If only the C line appears in the control region, the test indicates that no antibodies to H. pylori are detected and the result is negative. For additional details please refer to the instructions for use.This device was evaluated with 296 confirmed clinical serum specimens, 144 were positive and 152 were negative. All the specimens were blind labeled. The sensitivity of this device was calculated to be 95.1% (137/144) and the specificity to be 94.1% (143/152).Other closely related microorganisms were evaluated for cross reactivity with the test. Proteins of those microorganisms were spiked into the H. pylori positive and negative specimens at a highconcentration and tested separately. None of the microorganisms affected the test results positive or negative.No interference was found with Common Biological Analytes. For additional details please refer to the instructions for use.Diagnostic Automation Inc. also offers other Infectious Diseases Rapid tests, and Infectious Diseases ELISA test kits. For more information about Rapid tests, CLIA tests, IFA kits, or ELISA test kits, please contact our Customer Service Representatives at 818-591- .H. Pylori Rapid Test (Serum Cassette) -1H. Pylori Antigen Rapid Test (Cassette) -1H. pylori IgG ELISA kitH. pylori IgM ELISA kitH. Pylori Antigen ELISA kitAdditional H. pylori kits available are:H. pylori IgA CLIA, H. pylori IgG CLIA & H. pylori IgM CLIA KitDiagnostic Automation Inc. also provides otherFor more information about Rapid Tests, ELISA Kits, IFA Kits, CLIA Test Kits, or Serology tests, please see our website home page, or contact our Customer Service Representativeat
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