TP Syphilis Test Device Cassette TP-P02D

Details

Introduction:

The Syphilis Rapid Test Device (Serum/Plasma) 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.

Principle

The Syphilis Rapid Test Device (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.

Specimen Collection:

• For serum, collect blood into a container without anticoagulant.  Allow the blood to clot and separate the serum from the clot.  Use the serum for testing.
• If the specimen cannot be tested on the day of collection, store the serum specimen in a refrigerator or freezer.
• Bring the specimens to room temperature before testing.  Do not freeze and thaw the specimen repeatedly.

Test Procedure:

1. 1.Allow the sealed Anti-Syphilis test Device, serum specimens and control solution to reach room temperature (18-30°C).
2. 2.Remove the test device from the sealed pouch.
3. 3.Using the provided disposable pipette, transfer 3 drops of serum/plasma specimen (approximately 75 µL) to the specimen well (S) of the device and start the timer.
4. 4.Wait 10-15 minutes and read results.  Do not read results after 20 minutes