Syphilis Antibody Test Device For TP Detection

The SYP-W21 Syphilis Rapid Test Device is based on a qualitative membrane immunoassay. Recombinant Syphilis antigen is immobilized in the test line region, while Syphilis antigen-coated particles are incorporated into the test device.

When a specimen is added to the specimen well, TP antibodies, if present, react with the Syphilis antigen-coated particles. The resulting mixture migrates chromatographically along the membrane and interacts with the immobilized Syphilis antigen.

If the specimen contains TP antibodies (IgG and/or IgM), a colored line appears in the test region (T), indicating a positive result. If TP antibodies are not present, no colored line appears in the test region, indicating a negative result. A colored line in the control region (C) confirms proper specimen application and membrane migration.

Whole Blood, Serum & Plasma Compatible

IgG & IgM Detection

Rapid Visual Results

Simple Testing Procedure

Built-In Procedural Control

Bring the test device, specimen and buffer to room temperature (15–30°C) before testing.

For Serum or Plasma: Add 1 drop of serum or plasma (approximately 25 μL) to the specimen well, followed by 2 drops of buffer (approximately 80 μL).

For Whole Blood: Add 2 drops of whole blood (approximately 80 μL) to the specimen well, followed by 1 drop of buffer (approximately 40 μL).

Start the timer and read the result at 10 minutes. Do not interpret results after 30 minutes.

Positive Result: Both the C line and T line appear. Any visible colored line in the test region should be considered positive, regardless of its intensity.

Negative Result: Only the C line appears, while no line appears in the T region.

Invalid Result: The C line does not appear. The test should be repeated using a new device.

According to the supplied product insert, the SYP-W21 was compared with a leading commercial TPHA Syphilis test.

Relative Sensitivity: 99.5%
Relative Specificity: 99.3%
Overall Accuracy: 99.4%

The evaluation included 940 clinical specimens. In the reported precision studies, negative, low-positive, medium-positive and high-positive specimens were correctly identified more than 99% of the time in both within-run and between-run testing.

Materials Provided:
• Test Devices
• Droppers
• Buffer
• Package Insert

Materials Required but Not Provided:
• Specimen collection containers
• Lancets for fingerstick whole blood
• Centrifuge
• Timer
• Heparinized capillary tubes and dispensing bulb for fingerstick whole blood

The SYP-W201 can be used with whole blood collected by venipuncture or fingerstick, as well as serum and plasma.

Serum and plasma specimens may be stored at 2–8°C for up to 3 days. For long-term storage, specimens should be kept below −20°C. Whole blood collected by venipuncture may be stored at 2–8°C when testing is performed within 2 days, while fingerstick whole blood should be tested immediately.

Store the test as packaged in the sealed pouch at 2–30°C.

• Keep the test sealed until use.
• Do not freeze.
• Do not use after the expiration date.
• Do not use if the pouch is damaged.
• Protect the test from excessive humidity and temperature conditions.

The SYP-W21 is a qualitative test for TP antibodies and does not determine antibody concentration. A positive result should not be used as the sole criterion for diagnosing syphilis. Clinical information and other appropriate diagnostic methods should be considered when interpreting results.

A negative result does not completely exclude the possibility of TP infection; additional testing may be appropriate when clinical symptoms persist.

For professional in vitro diagnostic use only.

1. How long does the test take?

Results should be read at 10 minutes. Do not interpret results after 30 minutes.

2. What does a positive result look like?

Both the C and T lines appear. Any visible color in the T region should be considered positive.

3. What does a negative result look like?

Only the C line appears, with no visible T line.

4. What does an invalid result mean?

If the control line does not appear, the result is invalid and the test should be repeated with a new device.

5. Can fingerstick whole blood be used?

Yes. The instructions provide a procedure for collecting and testing fingerstick whole blood.

6. How should the test be stored?

Store the test at 2–30°C in its sealed pouch. Do not freeze.