Cargando…
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...
Autores principales: | , , , , , |
---|---|
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 |
_version_ | 1782358945340325888 |
---|---|
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. |
format | Online Article Text |
id | pubmed-4339936 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Medknow Publications & Media Pvt Ltd |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT tiwariaseemk evaluationofanewserologicaltestforsyphilisbasedonchemiluminescenceassayinatertiarycarehospital AT pandeyprashantk evaluationofanewserologicaltestforsyphilisbasedonchemiluminescenceassayinatertiarycarehospital AT dararavic evaluationofanewserologicaltestforsyphilisbasedonchemiluminescenceassayinatertiarycarehospital AT rawatganeshs evaluationofanewserologicaltestforsyphilisbasedonchemiluminescenceassayinatertiarycarehospital AT rainavimarsh evaluationofanewserologicaltestforsyphilisbasedonchemiluminescenceassayinatertiarycarehospital AT bhargavaricha evaluationofanewserologicaltestforsyphilisbasedonchemiluminescenceassayinatertiarycarehospital |