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

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 sens...

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Autores principales: Tiwari, Aseem K., Pandey, Prashant K., Dara, Ravi C., Rawat, Ganesh S., Raina, Vimarsh, Bhargava, Richa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4339936/
https://www.ncbi.nlm.nih.gov/pubmed/25722576
http://dx.doi.org/10.4103/0973-6247.150955
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author Tiwari, Aseem K.
Pandey, Prashant K.
Dara, Ravi C.
Rawat, Ganesh S.
Raina, Vimarsh
Bhargava, Richa
author_facet Tiwari, Aseem K.
Pandey, Prashant K.
Dara, Ravi C.
Rawat, Ganesh S.
Raina, Vimarsh
Bhargava, Richa
author_sort Tiwari, Aseem K.
collection PubMed
description 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 <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.
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spelling pubmed-43399362015-02-26 Evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital Tiwari, Aseem K. Pandey, Prashant K. Dara, Ravi C. Rawat, Ganesh S. Raina, Vimarsh Bhargava, Richa Asian J Transfus Sci Original Article 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 <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. Medknow Publications & Media Pvt Ltd 2015 /pmc/articles/PMC4339936/ /pubmed/25722576 http://dx.doi.org/10.4103/0973-6247.150955 Text en Copyright: © Asian Journal of Transfusion Science http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Tiwari, Aseem K.
Pandey, Prashant K.
Dara, Ravi C.
Rawat, Ganesh S.
Raina, Vimarsh
Bhargava, Richa
Evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital
title Evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital
title_full Evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital
title_fullStr Evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital
title_full_unstemmed Evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital
title_short Evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital
title_sort evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4339936/
https://www.ncbi.nlm.nih.gov/pubmed/25722576
http://dx.doi.org/10.4103/0973-6247.150955
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