|Sample Type:||Feces||Target Disease:||Helicobacter Pylori|
|Warranty:||24 Months||Production Standard:||ISO13485:2016|
|Application:||For Professional In Vitro Diagnostic Use Only||Material:||Colloidal Gold, Plastic|
CE h pylori antigen test kit,
Feces h pylori antigen test kit,
Helicobacter Pylori Rapid Diagnostic Kit
CE H.Pylori Antigen Rapid Test Feces Sampling Quick Diagnosic High Accuracy
The H. pylori Antigen Rapid Test (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of Helicobacter pylori antigens in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of H. pylori infection.
• One pouch containing a rapid test cassette with desiccant.
• Specimens dilution tube with buffer
• Package insert
Bring tests, specimens, buffer and/or controls to room temperature(15-30°C) before use. 1. Specimen collection and pre-treatment: 1) Best results will be obtained if the assay is performed within 6 hours after collection. 2) Unscrew and remove the dilution tube applicator stick. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of a pea). 3) Place the applicator stick back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube. 4) Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. 2. Testing 1) Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. To obtain a best result, the assay should be performed within one hour. 2) Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 2-3 (80-100 μL) drops of solution into the specimen well (S) of the test device. Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window. As the test begins to work, you will see color move across the membrane. 3. Wait for the colored band(s) to appear. The result should be read in 15 minutes. Note: If the specimen does not migrate (presence of particles), centrifuge the extracted specimens contained in the extraction buffer vial. Collect 80 µL of supernatant, dispense into the specimen well (S) of a new test device and start afresh following the instructions mentioned above.
[INTERPRETATION OF RESULTS]
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.The result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
DEWEI Medical Equipment Co., Ltd is a leading and professional manufacturer of IVD products,it is a high-tech enterprise specialized in developing, manufacturing and marketing of Clinical Laboratory analyzer & reagents, such as Hematology Analyzer & Reagents, Virus RNA Preservation & Extraction Kits, Urine Sediment Reagents and Washing Solutions.
DEWEI products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
Qulity is primary concern, DEWEI team is strict on quality control systems thus our products have CE, ISO, CFDA and other international standards certificates.
The view of DEWEI is to be the most professional and respected enterprise in IVD field, DEWEI will go on providing best service to you by the outstanding R&D and cost-effective products.