Basic Info.
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.
INTRODUCTION
Gastritis and peptic ulcers are among the most common human diseases. Since the discovery of H. pylori (Warren & Marshall, 1983), many reports have suggested that this organism is one of the major causes of ulcer diseases (Anderson & Nielsen, 1983; Hunt & Mohamed, 1995; Lambert et al, 1995). Although the exact role of H. pylori is not yet fully understood, eradication of H. pylori has been associated with the elimination of ulcer diseases. The human serological responses to infection with H. pylori have been demonstrated (Varia & Holton, 1989; Evans et al, 1989). The detection of IgG antibodies specific to H. pylori has been shown to be an accurate method for detecting H. pylori infection in symptomatic patients. H. pylori may colonize some asymptomatic people. A serological test may be used either as an adjunct to endoscopy or as an alternative measure in symptomatic patients.
| Storage | 2~30 º C |
| Specimen | Whole Blood/Serum/Plasma |
| Component | Rapid Test + Buffer + Pipettes |
| Principle | Colloidal gold rapid tests |
| Reading | Within 15mins |
| Package | 40tests/box |
| Trademark | Dewei |
| Origin | China |
MAIN CONTENTS
• A reaction test Cassette with desiccant.
• Buffer
• Disposable pipettes.
• 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
Bring tests, specimens, buffer and/or controls to room temperature (15 30°C) before use.
Transfer 2 drops of serum or plasma to the specimen well (S) with the provided disposable pipette, then start the timer.
For Whole Blood
Transfer 1 drop of whole blood to the specimen well (S) of the cassette with the provided disposable pipette, then add 1~2 drop of buffer and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the result area in the center of the device.
3. Wait for the colored band(s) to appear. The result should be read within 10-15 minutes. Do not interpret the result after 10 minutes.
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.
We also offer H.Pylori Antigen Rapid Test if you need!
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