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Basic Info.
Product Description
INTENDED USE
Vstrip H. pylori Antigen Rapid Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antigen in unpreserved human stool specimens. Test results are intended to aid in the initial diagnosis and treatment of H. pylori infection. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.
INTRODUCTION
H.pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis. Both invasive and non-invasive methods are used to diagnose H.pylori infection in patients with symptoms of gastrointestinal disease.
Manufacturer | Dewei Medical Equipment Co., Ltd |
Product Categories | IVD Test |
Principle | Rapid Colloidal Gold Immunochromatography |
Detection | Qualitative |
Storage | 2~30 º C |
Component | Rapid Test |
Package | 25T/box, 50T/Box, 100T/Box |
Trademark | Dewei |
Origin | China |
MAIN CONTENTS
• One pouch containing a reaction test Cassette with desiccant.
• Specimens dilution tube with buffer.
• Instructions for use.
STORAGE AND STABILITY
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
PRECAUTIONS
• For in vitro diagnostic use only.
• Do not use after expiration date.
• The test Cassette should remain in the sealed pouch until use.
• The used test Cassette should be discarded according to local regulations.
DIRECTION OF USE
The H. pylori Antigen Rapid Test (Feces) is intended only for use with human fecal specimens.
Perform the testing immediately after the specimen collection. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 72 hours.
Bring specimens to room temperature prior to testing.
Pack the specimens in compliance with applicable regulations for transportation of etiological agents, in case they need to be shipped.
INTERPRETATION
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
DEWEI products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research centers, and college laboratories. Quality is the 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 the IVD field, DEWEI will go on to provide the best service to you with outstanding R&D and cost-effective products.
Certificate
Production Workshop
Transportation
1, Are you a manufacturer?
Yes, we are a manufacturer based in Foshan City, Guangdong province. We have different production lines, more than 5000 square meter facility.
2, Can you put our logo or text on the products or packages?
Yes, we can provide OEM goods.
3, Could you provide free samples for our testing before we place an order?
Sure, we'd like to offer free samples for you, but the freight cost should be paid by the buyer.
4, How to make payment?
By T/T, D/P, L/C, Paypal, Western Union and Made in China are both acceptable.
6, Which seaport and airport are the nearest to your factory?
The near seaport is Guangzhou Nansha seaport & Shenzhen Shekou seaport. Guangzhou, Shenzhen, & Hongkong Airports are both convenient.
7, What is your best delivery time?
Depend on your order quantities. 3-20 working days after payment is received.