INTENDED USE
The Tuberculosis (TB) Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of anti-TB antibodies (Isotypes IgG, IgM and IgA) in whole blood, serum or plasma specimens. This kit is intended for use as an aid in the diagnosis of Tuberculosis.
| 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 |
PRINCIPLE
The Tuberculosis (TB) Rapid Test detects anti-TB antibodies through visual interpretation of color development on the internal strip. TB antigens are immobilized on the test region of the membrane. During testing, the specimen reacts with TB antigen conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are sufficient antibodies to TB in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the 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, 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. Transfer 3 drops of serum/plasma (approximately 75 µL) to the specimen well (S) of the device with the provided disposable pipette, and start the timer.
Allow 2 drops of whole blood (approximately 50 µL) to fall into the center of the specimen well(s) of the test device then add 1 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 membrane.
3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 30 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.
PRODUCT IMAGES
R&D TEAM
PRODUCTION LINE
CERTIFICATES
EXHIBITIONS
SHIPMENTS
Audited Supplier 
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