Audited Supplier
TYP
IVD Reagent
Rapid Test + Extraction Tube with Buffer+Dropper
Feces/Serum/Plasma
Within 5 Mins
2~30 º C
Immunochromatography
24 Months
CE
Professional Used
Dewei
25tests/Box 40tests/Box
1000tests/carton
China
Product Description
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.
PRINCIPLE
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.
WARNINGS AND PRECAUTIONS
Immunoassay for in vitro diagnostic use only.
Do not use after expiration date.
The test should remain in the sealed pouch until use.
The used test should be discarded according to local regulations.
STORAGE AND STABILITY
The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
Keep away from direct sunlight, moisture and heat.
Do not freeze.
Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
OPERATION
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
Separate the serum or plasma from blood as soon as possible to avoid haemolysis. Only clear, non-haemolysed specimens can be used.
Feces Specimen:
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 OF RESULTS
Preliminary positive (+)Only one colored band appears, in the control region (C). No colored band appears in the test region (T).Negative (-)Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).InvalidControl 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.
| Storage | 2~30 º C |
| Specimen | Feces (Stool) Whole Blood/Serum/Plasma |
| Component | Rapid Test + Extraction Tube with Buffer |
| Principle | Colloidal gold rapid tests |
| Reading | Feces (Stool): Within 5 mins Whole Blood/Serum/Plasma: Within 15mins |
| Package | 25tests/box |
| Trademark | Dewei |
| Origin | China |
PRINCIPLE
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.
WARNINGS AND PRECAUTIONS
Immunoassay for in vitro diagnostic use only.
Do not use after expiration date.
The test should remain in the sealed pouch until use.
The used test should be discarded according to local regulations.
STORAGE AND STABILITY
The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
Keep away from direct sunlight, moisture and heat.
Do not freeze.
Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
OPERATION
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1. Specimen collection and pre-treatment:
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:
Best results will be obtained if the assay is performed within 6 hours after collection.
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 4 different sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of a pea).
Place the applicator stick back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.
2. Test:
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.2. Test:
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.
3. The result should be read in 15 minutes. Do not interpret the result after 15 minutes.
Preliminary positive (+)Only one colored band appears, in the control region (C). No colored band appears in the test region (T).Negative (-)Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).InvalidControl 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.
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