Product Description:

The H. pylori Stool Antigen Test is an in vitro qualitative immunochromatographic assay designed for the swift identification of Helicobacter pylori antigens in human stool specimens. Its purpose is to assist in diagnosing H. pylori infection, monitor therapeutic efficacy, and confirm H. pylori eradication in patients with peptic ulcers.

Feature:

Highly Sensitive Detection: The colloidal gold rapid test is known for its high sensitivity detection, which can accurately detect tiny viruses. Even individuals with very low viral loads have the potential to be identified in time, facilitating early diagnosis and treatment.

User-friendly cassette type: The Biovantion product features a user-friendly cassette type that is easy to operate and read. This design simplifies the testing process, allowing testing to be performed conveniently even in non-professional medical environments, reducing the risk of operational errors.

Self-Testing Function: The self-testing function of the Colloidal Gold Rapid Test allows individuals to test at home without going to a clinic. This increases the privacy and convenience of testing.

Achieve rapid detection: The results can be obtained quickly within 5-15 minutes, providing a timely judgment and helping to take necessary actions in a timely manner.

Not a substitute for professional medical advice or testing: Although the Colloidal Gold Rapid Test is very sensitive, it is not a substitute for professional medical advice or testing. Although this test method is convenient, it still requires confirmation and treatment by a professional medical institution to ensure the accuracy of the results and appropriate follow-up steps.

Summary:

Helicobacter pylori is a corkscrew-shaped, gram-negative rod that lives in the mucous layer of the stomach. H. pylori infection is now accepted as the most common cause of gastritis, and is etiologically involved in gastric ulcer, duodenal ulcer, gastric adenocarcinoma and primary gastric B-cell lymphoma.1,2 The organism is very common, infected at least half of the world’s population. H. pylori infection is typically acquired in childhood. Once acquired, infection persists chronically, probably continuing in the. stomach throughout life. The damage to gastric structure and function of stomach is constant and direct. Approximately one in six of H. pylori infection develops peptic ulcer disease and a small portion of H. pylori infection leads to gastric cancer.3 The diagnostic tests for H. pylori can be classified into two categories: Invasive and Noninvasive tests. Direct detection by invasive test procedures requires an endoscopy and biopsy specimens from antrum and stomach body.4 The presence of H. pylori is then confirmed by direct culture, histological examination or rapid urease test. The endoscopy and biopsy specimens offer direct detection of active H. pylori infections. Although the procedure is highly specific and high positive predictive value, the cost and discomfort to the patients are very high. The most widely available noninvasive test is probably the serological based test. The serology test detects H. pylori specific IgG antibody in patient serum with current or prior infection.5,6 Serology test is a simple, convenient test with relative high sensitivity. The main limitation of serology test is the inability to distinguish current and past infections. Antibody may be present in the patient’s serum long after eradication of the organism.6 The urease breath test (UBT) with 14C or 13C labeled urea, is a noninvasive test based on the urease activity of the organism. UBT detects active H. pylori infection and is highly sensitive and specific. The UBT requires a high density and active bacteria and should not be performed until 4 weeks after therapy to allow residual bacterial to increase to a sufficient number for detection.7

H. pylori Antigen Test is an imunochromatographic assay that uses antibody- coated colloidal gold to detect the presence of H. pylori antigens in stool specimens. The test detects directly antigens in specimens for an active infection. The test is simple and easy to perform and the test results can be visually interpreted within 15 minutes

Principle:

H. pylori Stool Antigen Test is a sandwich solid phase immunochromatographic assay. To perform the test, an aliquot of diluted stool sample is added to the sample well of the test cassette. The sample flows through a label pad containing H. pylori antibody coupled to red-colored colloidal gold. If the sample contains H. pylori antigens, the antigen will bind to the antibody coated on the colloidal gold particles to form antigen-antibody-gold complexes. These complexes move on the nitrocellulose membrane by capillary action toward the test line region on which H. pylori specific antibodies are immobilized. As the complexes reach the test line, they will bind to the antibody on the membrane in the form of a line. A second red control line will always appear in the result window to indicate that the test has been correctly performed and the test device functions properly. If H. pylori antigen is not present or lower than the detection limit of the test, only the control line will be visible. If the control line dose not developed, the test is invalid.

Customization:

Customize your Biovantion Colloidal Gold Rapid Test with our product customization services. The model number of this test is Cassette and it is made in China. It has ISO13485 certification and a minimum order quantity of 50. The price is negotiable and the delivery time is 7-15 days.

With our customization services, you can tailor the Biovantion Colloidal Gold Rapid Test to meet your specific needs. You can even create a self test or home test version of this product for convenient and reliable testing at home.

Support and Services:

The Colloidal Gold Rapid Test is a point-of-care test that is used to detect the presence of certain antibodies in human blood or serum. It is intended for use as an aid in the diagnosis of infectious diseases, including COVID-19. The test is designed to be easy to use and provides results in as little as 10 minutes.

Our technical support team is available to provide assistance with any questions or issues that may arise during the use of the Colloidal Gold Rapid Test. We also offer services to help with the implementation of the test in various healthcare settings, including training and education for healthcare professionals and assistance with regulatory compliance.

Main Constituent:

1. Test Cassette: 20 test / box

Test Strip: 50 tests / box

2. Sample collection tube with diluent 1ml ×20 for cassette

Sample diluent 30ml×1 for strip

3. Product instruction: 1

Assay Procedure:

1. Bring Membrane Plate and samples to room temperature (20-30°C) before use (approximately 30 minutes).

2. Remove the test cassette/strip from the sealed foil pouch and place the plate on flat desk.

3. Bring all materials and specimens to room temperature (8～30℃).

4.1 H. pylori Stool Antigen test Strip

1) Add 500μl sample diluents into the test tube.

2) Add proper specimens (S:5 mm in diameter, L: 50μl) into the tube to make the concentration of the solution up to 5%～10% and mix thoroughly.

3) Deliver 100μl (2～3drops ) of diluted stool sample to the sample pad of the test strip.

4.2 H. pylori Stool Antigen test Cassette

1) To take a portion of feces (about 100mg), insert the sterile swab into a stool sample that presents the most secretion under visual inspection.

2) Open the sample collection tube and then insert the swab into the sample collection tube containing assay diluents.

3) Swirl the swab at least 10 times until the samples has been dissolved into the assay diluents and discard the swab while squeezing the swab against the wall of tube, replace the cap.

4) Deliver 100μl (2～3drops ) of diluted stool sample to the sample well of the test card.

5. Read the result in 5～10 minutes. A strong positive sample may show result earlier.

Note: Results after 15 minutes may not be accurate.