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Treponema pallidum haemagglutination test for the serodiagnosis of syphilis.
| - RELIABLE: |
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- Quality system certified ISO 9001 and ISO 13485.
- Specificity : 98,5% (*).
- Sensitivity : 99,6% (*).
(*) - Study done in an European reference center of over 409 positive samples and 675 negative samples.
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| - PRACTICAL: |
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- Can be done with serum without heat activation.
- Long shelf life : 18 months.
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| - PACKAGING: |
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- Kuts of 100 tests containing :
>>>>>>> - Test cells,
>>>>>>> - Control cells,
>>>>>>> - Positives and negatives control.
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| - EFFICIENT: |
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- 45 minutes of sedimentation at room temperature.
- Qualitative and quantitative results.
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RESULTS AND INTERPRETATION
Agglutinated cells form an even layer over the bottom of the well. Non-agglutinated cells form a compact button in the centre of the well. Weakly agglutinated cells form a characteristic ring pattern. Agglutination of the Test Cells but not the Control Cells indicates the presence of specific antibody to T.pallidum. Absence of aggulatination indicates that antibody is below the limit of detection of the system.
Observations:
1) Do not use the Control Cell pattern as an indication of a negative result since they give a more compact button of cells.
2) Agglutination of the Control Cells as well as the Test Cells indicates the presence of anti-cell antibody. In this event the test is not valid and should be repeated.
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