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

Autor: Aseem K Tiwari, Prashant K Pandey, Ravi C Dara, Ganesh S Rawat, Vimarsh Raina, Richa Bhargava
Jazyk: angličtina
Rok vydání: 2015
Předmět:
Zdroj: Asian Journal of Transfusion Science, Vol 9, Iss 1, Pp 65-69 (2015)
Druh dokumentu: article
ISSN: 0973-6247
1998-3565
DOI: 10.4103/0973-6247.150955
Popis: Context: 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. Aims: 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. Materials and Methods: 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. Results: VITROS ® syphilis TPA showed 100% sensitivity and specificity with precision (20 days study) of
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