PRINCIPLE
The Syphilis 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, indicating that the proper volume of specimen has been added and membrane wicking has
occurred.
WARNINGS AND PRECAUTIONS
For professional in vitro diagnostic use only.
Do not use after the expiration date indicated on the package. Do not use the test if the foil
pouch is damaged. Do not reuse tests.
This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary
state of the animals does not completely guarantee the absence of transmissible pathogenic
agents. It is therefore, recommended that these products be treated as potentially infectious, and
handled by observing usual safety precautions (e.g., do not ingest or inhale).
Avoid cross-contamination of specimens by using a new specimen collection container for each
specimen obtained.
Read the entire procedure carefully prior to testing.
Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all
specimens as if they contain infectious agents. Observe established precautions against
microbiological hazards throughout the procedure and follow standard procedures for the
proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are assayed.
Humidity and temperature can adversely affect results.
Used testing materials should be discarded according to local regulations.
TEST PROCEDURE
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. For best results,
the assay should be performed within one hour.
2. Using the provided dropper, transfer 3 drops of serum/plasma specimen (approximately 75 µL)
to the specimen well (S) of the device and start the timer.
OR
Transfer 2 drops of whole blood specimen (approximately 50 µL) to the specimen well (S) of
the device with the provided dropper, then add 1 drop of buffer (approximately 40 µL) 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, you will see color move 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.
