INTENDED USE
The HIV 1/2 Rapid Test Strip (Serum/Plasma) is a rapid visual immunoassay for the qualitative, presumptive detection of antibodies to HIV-1/HIV-2 in human serum or plasma specimens. This kit is intended for use as an aid in the diagnosis of HIV infection.
| Storage |
2~30 º C |
| Specimen |
Type 1: Whole Blood/Serum/Plasma
Type 2: Serum/Plasma |
| Component |
Rapid Test + IFU |
| Principle |
Colloidal gold rapid tests |
| Reading |
Within 15mins |
| Package |
Professional Used: 40tests/box
Home Used: 1test/box |
| Trademark |
Dewei |
| Origin |
China |
PRINCIPLE
The HIV 1/2 Rapid Test (Serum/Plasma) detects antibodies to HIV-1/HIV-2 through visual interpretation of color development on the internal strip. Recombinant HIV antigens are immobilized on the test region of the membrane. During testing, the specimen reacts with HIV 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 HIV-1/HIV-2 antibodies 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
Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. For best results, the assay should be performed within one hour.
2. Use pipette to transfer 2 drops (around 50μL) of specimen to the sample pad of the strip and start the timer.
Avoid trapping air bubbles on the sample pad, 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 20 minutes.
PRODUCT IMAGES
R&D TEAM
PRODUCTION LINE
CERTIFICATES
EXHIBITIONS
SHIPMENTS
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