One Step HIV 1/2 Whole Blood/Serum/Plasma Test
Wondfo® One Step HIV 1/2 Whole Blood/Serum/Plasma Test
is intended for use by trained users(in either laboratory or
point-of-care settings), and is a qualitative, screening, POCT for detection of HIV 1/2 antibodies in human
venous whole blood, fingerstick whole blood, serum or
plasma, aid to diagnosis of HIV infection.
-
CONTENT OF THE KIT
A. Kit components
Each individual sealed pouch contains one test cassette, one dropper and one desiccant pouch (for storage purposes only). Each test cassette contains one plastic cassette and one test strip.
For W006-C4P2 (25 Tests/Kit)
25 Pouches One bottle Buffer (5ml/bottle) One piece of Instruction for Use
For W006-C4P2-F (40 tests/Kit)
40 Pouches Two bottles Buffer (5ml/bottle) One piece of Instruction for Use
B. Reactive ingredients of main components
One test strip includes: Gold conjugate (HIV gp41/gp36 fusion recombinant antigen-gold colloid and rabbit IgG polyclonal antibody-gold colloid), Test line (HIV gp41 recombinant antigen and HIV gp36 recombinant antigen) and Control line (Goat anti rabbit IgG polyclonal antibody).
-
STORAGE AND STABILITY
1. The kit and the unused buffer must be stored at 2℃-30℃ before expiration date; the opened buffer should store at 2 ℃-30℃, no more than 8 weeks.
2. Use the kit within 1 hour once the pouch is opened.
3. Use the kit under the condition of the humidity from 20% to 90% and the temperature from 10℃ to 30℃.
4. Recap and store the Buffer vial in the original container after use.
5. Shelf-life of the test devices and the Buffer are 24 months from the manufacturing date.
6. Keep away from sunlight, moisture, and heat.
Specification
Description |
Cat. No. |
Pouch
(pcs) |
Buffer
( bottle) |
Instruction
(pcs) |
Alcohol Swab
(pcs) |
Sterile Lancet
(pcs) |
Safety Lancet
(pcs) |
Specificity |
Sensitivity |
|
|
|
|
|
|
18G |
21G |
23G |
|
|
W006-C4P2 |
25 |
1 |
1 |
- |
- |
- |
- |
- |
100% |
99.96% |
W006-C4P2-F |
40 |
2 |
1 |
- |
- |
- |
- |
- |
100% |
99.96% |
W006-P0045 |
25 |
1 |
1 |
25 |
25 |
- |
- |
- |
100% |
99.96% |
W006-P0046 |
25 |
1 |
1 |
25 |
- |
25 |
- |
- |
100% |
99.96% |
W006-P0047 |
25 |
1 |
1 |
25 |
- |
- |
25 |
- |
100% |
99.96% |
W006-P0048 |
25 |
1 |
1 |
25 |
- |
- |
- |
25 |
100% |
99.96% |
W006-P0049 |
40 |
2 |
1 |
40 |
40 |
- |
- |
- |
100% |
99.96% |
W006-P0050 |
40 |
2 |
1 |
40 |
- |
40 |
- |
- |
100% |
99.96% |
W006-P0051 |
40 |
2 |
1 |
40 |
- |
- |
40 |
- |
100% |
99.96% |
W006-P0052 |
40 |
2 |
1 |
40 |
- |
- |
- |
40 |
100% |
99.96% |
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