INTENDED USE
Typhoid fever Rapid Test is an immunochromatographic assay designed for the qualitative detection of specific IgG and IgM andodies against a specific Salmonella typhi antigen in human serum, plasma or whole blood. It is intended to be used as in vitro diagnostic of typhoid fever. The results obtained should not be the sole determinant for clinical decision.
| Storage |
2~30 º C |
| Specimen |
Whole Blood/Serum/Plasma |
| Component |
Rapid Test + Extraction Tube with Buffer |
| Principle |
Colloidal gold rapid tests |
| Reading |
Within 15mins |
| Package |
40tests/box |
| Trademark |
Dewei |
| Origin |
China |
PRINCIPLE
The Typhoid Test Kit is a lateral flow chromatographic immunoassay. The test strip in the cassette consists of: 1) a burgundy colored conjugate pad containing recombinant H antigen and O antigen conjugated with colloidal gold (HO conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test lines (G and M lines) and a control line (C line). The M line is pre-coated with monoclonal anti-human IgM for the detection of IgM anti-S. typhi and paratyphi, the G line is pre-coated with reagents for the detection of IgG anti-S. typhi and paratyphi , and the C line is pre-coated with goat anti-rabbit IgG.
When an adequate volume of test specimen is dispensed into the sample well of the cassette, the test specimen migrates by capillary action across the test cassette. IgM/IgG antibodies, if present in the specimen, will bind to the HO conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM/IgG antibody forming a burgundy colored M/G line, indicating a S. typhi or paratyphi IgM/IgG positive test result.
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. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
2. Using the provided disposable pipette, transfer 1 drop of whole blood, serum or plasma to the specimen well (S) of the cassette and add 1 drop of buffer to the sample well, 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.
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.
PRODUT DETAILS (Which do you prefer, Antibody or Antigen test?)
COMPANY
TECHNICIAN
PRODUCTION
SHIPMENT
EXHIBITIONS
Audited Supplier 
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