Product Description
INTENDED USE
The H. pylori Antibody Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual It is used to detect Helicobacter pylori antibody in human whole blood, serum or plasma samples.This kit is intended for use as an aid in the diagnosis of H. pylori infection.
PRINCIPLE
The Helicobacter pylori antibody rapid test, using immunochromatography to detect Helicobacter pylori antibody.Fix Helicobacter pylori antigen on the test area of the membrane. During testing, the specimen reacts with H. pylori antigen conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are sufficient antibodies to Helicobacter pylori in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
MAIN CONTENTS
• Rapid test with desiccant
• Buffer
• Pipette
• Package insert
STORAGE AND STABILITY
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
PRODUCT FEATURES
•Compatible with human serum, plasma or whole blood specimens
•Test sensitivity not impacted by the presence of gastric bleeding*
•Non-invasive, easy to perform procedure
•Results in only 15 minutes
•No equipment required
•Shelf Life: 24 months
•Storage Temperature: 2-30°C
DIRECTION OF USE
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use. 1. Remove the test from its sealed pouch, and place it on a clean, level surface. For best results, the assay should be performed within one hour. 2. Using the provided disposable pipette, transfer 2 drops of Serum/Plasma specimen to the sample pad of the strip and start the timer. OR Using the provided disposable pipette, transfer 1 drop of Whole Blood specimen to the sample pad of the strip. Then add 1 drop of buffer and start the timer. Avoid trapping air bubbles on the sample pad, and do not add any solution to the result window. As the test begins to work, color will migrate across the membrane. 3. Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.
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. 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.
QUALITY CONTROL
• Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.
• External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
For further operation or performance details, please refer to final instruction manual.
Detailed Photos
Company Profile
Dewei Medical Equipment Co.,Ltd was one of the earliest high-tech biological companies focusing on rapid diagnostics in China. it is a professional manufacture and exporter in the area of medical lines.Factory is located in Foshan city ,Guangdong Province.
Our main products include rapid test and laboratory consumables.More than 100 kinds product can sell in European,South USA ,Africa and other countries.The company conducts extensive cooperation with institutions of higher learning and introduces about five flexible talents including professors and doctors. we also provide OEM, ODM and technology support to customers. We've been and will keep on aiming at providing high quality products and excellent after-sales services to both domestic and overseas customers.
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FAQ
1.Are you a Manufacturer?
Yes,we are manufacturer based in Foshan,China with 100 workers,more than 5000 square meter non-dust workshop,advanced automate machines and professional R&D team ensure the high quality,speedy delivery and large production capacity.
2.Can we put our logo/text om the product or package?
Yes,we can do OEM or even ODM.All of our products can be customized.
3.Can you provide free samples?
Yes, free sample are available.
4.How long is your production time?
Our production time is usually two weeks after receiving the deposit and four weeks for one contaoner order quantity.
5.How to make the payment?
By T/T,L/C,Paypal,Western union and made in China is also acceptable.
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