TPHA Microplate Hemagglutination Test

The Giesse Diagnostics TPHA Microplate Hemagglutination Test is an in vitro diagnostic assay intended for the qualitative and semi-quantitative detection of antibodies against Treponema pallidum in human serum.

The test utilizes stabilized avian erythrocytes sensitized with Treponema pallidum antigens to produce visible hemagglutination patterns that aid laboratory interpretation. It is suitable for use in clinical laboratories by trained professionals as part of syphilis serological testing.

Results should always be interpreted together with clinical findings and other laboratory investigations.

• Qualitative and semi-quantitative detection
• Microplate hemagglutination method
• Ready-to-use reagents
• Human serum sample
• Includes positive and negative controls
• Easy visual interpretation
• For professional laboratory use
• CE-IVD marked
• ISO 9001 & ISO 13485 manufactured

For the qualitative and semi-quantitative determination of antibodies against Treponema pallidum in human serum for in vitro diagnostic use.

1. Allow reagents and samples to reach room temperature.
2. Prepare serum dilution according to the package insert.
3. Dispense samples and reagents into the microplate wells.
4. Incubate at room temperature for 45–60 minutes.
5. Read and interpret agglutination patterns according to the interpretation guide. 

• Test Cells Reagent (7.5 mL)
• Control Cells Reagent (7.5 mL)
• Diluent (20 mL)
• Positive Control (1 mL)
• Negative Control (1 mL)
• Instructions for Use

• For professional in vitro diagnostic use only.
• Use only fresh serum samples.
• Avoid highly hemolyzed or lipemic samples.
• Follow standard laboratory biosafety precautions.
• Handle human-derived materials as potentially infectious.
• Dispose of laboratory waste according to local regulations.

• Store tightly closed at 2–8°C.
• Do not freeze.
• Store vials upright.
• Avoid contamination after opening.
• Use before the expiration date.

• CE-IVD
• ISO 9001 Certified
• ISO 13485 Certified