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


OBJECTIVE
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.


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 <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.


CONCLUSIONS
Performance of the VITROS(®) syphilis TPA assay meets the requirements for its use as STS in blood bank, thus allowing consolidation with other transfusion transmittable infections screening assay on chemiluminescence platform, which is highly valuable for optimizing workflow and efficiency.
Department of Transfusion Medicine, Medanta, The Medicity, Gurgaon, Haryana, India.
Aseem K
AK
Tiwari
Department of Transfusion Medicine, Medanta, The Medicity, Gurgaon, Haryana, India.
Prashant K
PK
Pandey
Department of Transfusion Medicine, Medanta, The Medicity, Gurgaon, Haryana, India.
Ravi C
RC
Dara
Department of Transfusion Medicine, Medanta, The Medicity, Gurgaon, Haryana, India.
Ganesh S
GS
Rawat
Department of Laboratory and Transfusion Services, Medanta, The Medicity, Gurgaon, Haryana, India.
Vimarsh
V
Raina
Department of Gastroenterology, Medanta, The Medicity, Gurgaon, Haryana, India.
Richa
R
Bhargava
Non-treponemal test; serological test for syphilis; treponemal test