Helycobacter antibody self-test (berkeleyhealth)

HELICOBACTER PYLORI (ANTIBODIES) Helicobacter pylori (H. pylori) is a bacterium that chronically infects more than half of the world's population, playing a causal role in chronic gastritis, peptic ulcers, gastric cancer, and lymphoma associated with mucosal lymphoid tissue. In 1994, the National Institutes of Health recognized that most recurrent duodenal and gastric ulcers were caused by H. pylori and recommended antibiotic treatment. In the same year, the International Agency for Research on Cancer classified H. pylori as a group I human carcinogen due to its association with gastric adenocarcinoma.

WHY - BENEFITS The HELICOBACTER PYLORI test helps quickly diagnose infection by detecting the presence of specific IgG antibodies produced by the immune system in response to the bacteria. This helps prevent serious complications, such as ulcers and gastric cancer.

TEST PRINCIPLE The test is an immunochromatographic assay that detects the presence of IgG antibodies against H. pylori in the blood using gold-conjugated monoclonal antibodies integrated in the test strip.

RECOMMENDED USERS Individuals with gastric symptoms such as pain or burning in the upper abdomen, especially when fasting; People with associated symptoms such as nausea, feeling of fullness, reflux, loss of appetite, belching, weight loss, or diarrhea; Patients with gastric ulcers that can cause anemia due to prolonged bleeding.

TECHNICAL SPECIFICATIONS Detection limit (cut-off): 15 AU/mL Sensitivity: 87% Specificity: 84.2% Overall accuracy: 95.8% Performance data were obtained through a clinical study with 100 participants. Reference method used: IBL ELISA kit.

KIT CONTENTS: 1 sealed aluminum bag containing: 1 test device and 1 desiccant sachet; 1 transparent plastic bag with pipette for blood collection; 1 dropper bottle containing the diluent; 2 sterile lancets for collecting blood samples; 1 alcohol wipe; 1 leaflet with instructions for use.