Syphilis – Rapid Test Kit 99.6% Accuracy - Results at Home

Syphilis (TP) Antibody Rapid Test Kit (Colloidal Gold Method)

Purpose
This test kit is designed for qualitative detection of Treponema pallidum (TP) antibodies in human whole blood, serum, or plasma. TP is the causative agent of syphilis, which is primarily transmitted sexually. This rapid test assists in diagnosing syphilis infection in its various stages (primary, secondary, latent, tertiary) and is intended for professional use.

How It Works
The test uses the double-antigen sandwich method. If TP antibodies are present, they react with the colloidal gold-labeled antigens on the test strip, resulting in a red band on the test line (T line). The control line (C line) will always display a red band if the test has been conducted correctly, ensuring the test’s validity.

Sample Requirements

• Sample Types: Whole blood (fingerstick or venous), serum, or plasma
• Collection and Handling:
  • Serum/plasma: Separate immediately after collection to avoid hemolysis.
  • Whole blood: Use anticoagulant tubes if needed. Samples should be tested immediately after collection.
  • Avoid repeated freezing and thawing.

Testing Instructions

1. Bring the kit and sample to room temperature before testing.
2. Open the aluminum foil bag and remove the test pad.
3. For strip type: Add 1 drop of sample (10 μL) to the sampling area, followed by 3 drops of diluent.
4. For card type: Add the sample and then 3 drops of diluent to the designated area.
5. Wait 15–30 minutes for results:
   • Positive: Red bands appear on both the T line and C line.
   • Negative: Only the C line shows a red band.
   • Invalid: No red band on the C line; retest with a new kit.

Storage & Handling

• Store at 2–30°C, away from high temperature, humidity, and direct sunlight.
• Use test pads within 1 hour of opening, especially in hot or humid conditions.

Precautions

• Single-use only. Do not use damaged or expired kits.
• Samples and test components should be treated as infectious and disposed of safely.
• If the result is weak positive or invalid, confirm with additional testing methods.

Performance

• Sensitivity: 99.5%
• Specificity: 99.7%
• Accuracy: 99.6%
• Cross-reactivity: No cross-reactivity with other common viruses, such as HIV, Hepatitis, or other infections.