Abstract
Objective: The aim of this study was to evaluate VITROS(®) syphilis Treponema pallidum agglutination (VITROS(®) syphilis TPA) assay based on enhanced chemiluminescence principle for detection of syphilis infection in blood donors. Subject and method: A total of 110 random blood samples collected from the blood donors and 30 syphilis known sero-reactive samples stored at -20°C, were used to evaluate the performance of VITROS(®) syphilis TPA assay based on enhanced chemiluminescence assay on VITROS(®) immunodiagnostics system to analyze the terms of its sensitivity, precision, cross-reactivity and interference studies. Result: The results showed that VITROS(®) syphilis TPA got 100% sensitivity and specificity with precision (20 days study) of < 10% co-efficient of variation. There was no cross-reactivity with other viral and auto-immune antibodies. No interference was observed from endogenous interfering substances like free hemoglobin or fats. Conclusion: The results suggested that VITROS(®) syphilis TPA should be done to further reduce the risk of transfusion-transmitted TP infection, decrease unnecessary blood waste and loss of blood donors.
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