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Trade Verify
Address: B318 Building B, Western Silicon Valley, Bao'an District, Shenzhen, China
Contact name:Sherry Cai
Dewei Medical Equipment Co., Ltd |
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INTENDED USE
Typhoid fever Rapid Test is an immunochromatographic assay designed for the qualitative detection of Salmonella typhi antigen in human serum, plasma or feces. It is intended to be used as in vitro diagnostic of typhoid fever. It is intended to be used as an aid in the diagnosis of infection and to monitor the effectiveness of therapeutic treatment.
INTRODUCTION
The S. Typhi Ag Rapid Test is a qualitative, lateral flow immunoassay for the detection of Salmonella Typhi antigen in human feces, serum or plasma specimen. The membrane of the test strip contained in the cassette device is pre-coated with anti-Salmonella antibodies on the test line region of the strip. During testing, the feces, serum or plasma specimen reacts with the particle coated with anti-Salmonella antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-Salmonella antibodies on the membrane and generate a colored test line (T). The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored control line (C) will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
MAIN CONTENTS
• One pouch containing a reaction test Cassette with desiccant.
• Buffer
• Disposable pipettes.
• Instructions for use.
STORAGE AND STABILITY
• Store at 39~ 86 º F (4 ~ 30 º C) in the sealed pouch for 18 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 (1530°C) before use.
Serum/Plasma Specimen:
Separate the serum or plasma from blood as soon as possible to
avoid haemolysis. Only clear, non-haemolysed specimens can be used.
Feces Specimen:
Remove the test from its sealed pouch, and place it on a clean,
level surface. Label the cassette with patient or control
identification. For best results, the assay should be performed
within one hour.
Serum/Plasma Specimen:
Using the provided disposable pipette, transfer 2~3 drops of serum
or plasma to the specimen well (S) of the cassette, then start the
timer.
Feces Specimen:
Using a piece of tissue paper, break the tip of the dilution tube.
Hold the tube vertically and dispense 2~3 drops of solution into
the specimen well (S) of the test cassette, then 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 membrane.
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.
