Evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital

• Published in: Asian journal of transfusion science 2015-01, Vol.9 (1), p.65-69
• Main Authors: Tiwari, Aseem K, Pandey, Prashant K, Dara, Ravi C, Rawat, Ganesh S, Raina, Vimarsh, Bhargava, Richa
• Format: Article
• Language: English
• Subjects: Analysis; Health aspects; Infection; Membrane lipids; Non-treponemal test; Original; serological test for syphilis; Syphilis; treponemal test
• ISSN: 0973-6247; 1998-3565
• DOI: 10.4103/0973-6247.150955

Syphilis is a transfusion transmissible infections and it is mandatory to do serological test for syphilis (STS) on all donor blood samples. STS is usually based on detection of antibodies against the cardiolipin-lecithin antigen or against the Treponema-specific antigen. STS with good sensitivity and specificity helps enhance blood safety and consolidation of STS along with other transfusion transmittable infections such as human immunodeficiency virus, hepatitis-C virus, and hepatitis-B virus helps in reducing the errors and enhances efficiency. This study was designed to evaluate the performance of newly introduced VITROS(®) syphilis Treponema pallidum agglutination (TPA) assay based on enhanced chemiluminescence principle for its analytical performance for use as a STS on donor blood samples at a tertiary care health center in National Capital Region, India. A total of 108 random blood units collected from the donors (both voluntary and replacement donors) and 28 known syphilis 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(®) ECiQ immunodiagnostics system along with its analytical performance in terms of its sensitivity, precision, cross-reactivity and interference studies. VITROS(®) syphilis TPA showed 100% sensitivity and specificity with precision (20 days study) of