INTENDED USE
The Syphilis Rapid Test is a rapid visual immunoassay for the qualitative, presumptive detection of IgM and IgG antibodies to Treponema Pallidum (TP) in human whole blood, serum or plasma specimens. This kit is intended for use as an aid in the diagnosis of syphilis.
| 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; 25tests/box; 1test/Box |
| Trademark |
Dewei |
| Origin |
China |
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 test with patient or control identification. For best results, the assay should be performed within one hour.
2.Using the provided disposable pipette, transfer 2 drops of serum/Plasma to the specimen well (S) of the cassette with the provided disposable pipette, then start the timer.
OR
Transfer 1 drop of whole blood specimen to the specimen well (S) of the device cassette with the provided disposable pipette, 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 15 minutes. Do not interpret the result after 20 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.
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