CE ISO13485 marked TP rapid test (Whole blood/Serum)
TP rapid test (Whole blood/Serum) Strip/cassette/Device
TP rapid test (Whole blood/Serum) Strip/cassette/Device is a
sandwich method based rapid immunochromatographic assay for the
qualitative detection of antibodies (IgG and IgM) to Treponema
Pallidum (TP) in serum or plasma or whole blood to aid in the
diagnosis of Syphilis.
TheSyphilis Rapid Test Device (Whole Blood/Serum/Plasma) detects
IgM and IgG antibodies to Treponema Pallidum (TP) through visual interpretation of color development on the internal
strip. Specific recombinant TP antigens are immobilized on the test region of the membrane. During
testing, the specimen reacts with recombinant TP-specific 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 Treponema Pallidum (TP) 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, indicatingthat the proper volume of specimen
has been added and membrane wicking has occurred.
1. Follow the illustration and allow test kit to equilibrate to
room temperature for 20-30min prior to testing.
2. Use the dropper, drip one drop (25μl)specimen to the
Instructions below the arrow and sample place.
3. And meanwhile add two drops(100ul) Sample Diluent .
4. Wait for 10-20 minutes and read results. Over 20 min, the result
1. Must use fresh specimen and avoid repetitive freezing, the result
will be invalid
2. Use it before expiry date.
3. The package of kit should not be opened until it reaches the room
temperature if it taken out from the
4, Old Serum can not be used. If the serum is thick, it can be used
only after being separated.
1. The test is for in-vitro diagnostic use only.
2. The test is qualitative filter detection,it can not be used as the final test for blood donor
STORAGE AND STABILITY
The test kit can be stored at room temperature (2 to 30°C) in the
sealed pouch to the date of expiration.The
test kit should be kept away from direct sunlight, moisture and