Performance evaluation of VITROS syphilis Treponema pallidum agglutination assay in blood donor samples by using centers for disease control and prevention reverse sequence algorithm

Background: VITROS syphilis Treponema pallidum agglutination (VSTPA) assay is a treponemal assay for the detection of antitreponemal antibody in the human serum or plasma using enhanced chemiluminescence technology. Centers for Disease Control and Prevention (CDC) has offered reverse sequence algori...

Full description

Bibliographic Details
Main Authors: Amardeep Pathak, Manushri Sharma, Narender Tejwani, Anurag Mehta
Format: Article
Language:English
Published: Wolters Kluwer Medknow Publications 2019-01-01
Series:Global Journal of Transfusion Medicine
Subjects:
Online Access:http://www.gjtmonline.com/article.asp?issn=2468-8398;year=2019;volume=4;issue=1;spage=69;epage=73;aulast=Pathak
id doaj-2bb12493ad54427580e93ee29eade306
record_format Article
spelling doaj-2bb12493ad54427580e93ee29eade3062020-11-25T00:34:58ZengWolters Kluwer Medknow PublicationsGlobal Journal of Transfusion Medicine2468-83982455-88932019-01-0141697310.4103/GJTM.GJTM_37_18Performance evaluation of VITROS syphilis Treponema pallidum agglutination assay in blood donor samples by using centers for disease control and prevention reverse sequence algorithmAmardeep PathakManushri SharmaNarender TejwaniAnurag MehtaBackground: VITROS syphilis Treponema pallidum agglutination (VSTPA) assay is a treponemal assay for the detection of antitreponemal antibody in the human serum or plasma using enhanced chemiluminescence technology. Centers for Disease Control and Prevention (CDC) has offered reverse sequence algorithm for screening syphilis. Aim and Objective: This study was undertaken to evaluate the performance of VSTPA assay over the nontreponemal (rapid plasma regain [RPR]) as well as treponemal assay based on immunochromatography principle, which is commonly used in blood transfusion centers, using CDC reverse sequence algorithm. Material and Methods: A total number of 33,367 donor samples were screened for the syphilis infection using either VSTPA assay or syphilis rapid card test and the syphilis reactivity rate was compared between both assays. Results: While screening with syphilis rapid card test, the percentage of reactivity observed was 0.36% whereas with VSTPA assay, the reactivity was increased to 0.87%. As per the CDC reverse sequence algorithm, the seroreactive samples in VSTPA assay were subjected to nontreponemal RPR test. The discordant samples which showed “nonreactive” in RPR assay were sent for syphilis confirmatory test based on fluorescent treponemal antibody absorption (FTA-ABS) test. In the reverse algorithm study, 40% of samples with discordant results were confirmed as “Positive” in FTA-ABS test confirming the superior sensitivity of VSTPA assay over nontreponemal RPR assay as well as treponemal syphilis rapid card test. Conclusion: Automation of syphilis screening using VSTPA assay helps in consolidation of the assay with other transfusion transmittable infections, namely, HIV, HBsAg, and anti-HCV screening assay on chemiluminescence platform which is highly valuable for optimizing workflow, efficiency with excellent sensitivity, and reliable specificity.http://www.gjtmonline.com/article.asp?issn=2468-8398;year=2019;volume=4;issue=1;spage=69;epage=73;aulast=PathakCenters for Disease Control and Preventionnontreponemal testreverse sequence algorithmsyphilistreponemal testVITROS Syphilis Treponema pallidum agglutination
collection DOAJ
language English
format Article
sources DOAJ
author Amardeep Pathak
Manushri Sharma
Narender Tejwani
Anurag Mehta
spellingShingle Amardeep Pathak
Manushri Sharma
Narender Tejwani
Anurag Mehta
Performance evaluation of VITROS syphilis Treponema pallidum agglutination assay in blood donor samples by using centers for disease control and prevention reverse sequence algorithm
Global Journal of Transfusion Medicine
Centers for Disease Control and Prevention
nontreponemal test
reverse sequence algorithm
syphilis
treponemal test
VITROS Syphilis Treponema pallidum agglutination
author_facet Amardeep Pathak
Manushri Sharma
Narender Tejwani
Anurag Mehta
author_sort Amardeep Pathak
title Performance evaluation of VITROS syphilis Treponema pallidum agglutination assay in blood donor samples by using centers for disease control and prevention reverse sequence algorithm
title_short Performance evaluation of VITROS syphilis Treponema pallidum agglutination assay in blood donor samples by using centers for disease control and prevention reverse sequence algorithm
title_full Performance evaluation of VITROS syphilis Treponema pallidum agglutination assay in blood donor samples by using centers for disease control and prevention reverse sequence algorithm
title_fullStr Performance evaluation of VITROS syphilis Treponema pallidum agglutination assay in blood donor samples by using centers for disease control and prevention reverse sequence algorithm
title_full_unstemmed Performance evaluation of VITROS syphilis Treponema pallidum agglutination assay in blood donor samples by using centers for disease control and prevention reverse sequence algorithm
title_sort performance evaluation of vitros syphilis treponema pallidum agglutination assay in blood donor samples by using centers for disease control and prevention reverse sequence algorithm
publisher Wolters Kluwer Medknow Publications
series Global Journal of Transfusion Medicine
issn 2468-8398
2455-8893
publishDate 2019-01-01
description Background: VITROS syphilis Treponema pallidum agglutination (VSTPA) assay is a treponemal assay for the detection of antitreponemal antibody in the human serum or plasma using enhanced chemiluminescence technology. Centers for Disease Control and Prevention (CDC) has offered reverse sequence algorithm for screening syphilis. Aim and Objective: This study was undertaken to evaluate the performance of VSTPA assay over the nontreponemal (rapid plasma regain [RPR]) as well as treponemal assay based on immunochromatography principle, which is commonly used in blood transfusion centers, using CDC reverse sequence algorithm. Material and Methods: A total number of 33,367 donor samples were screened for the syphilis infection using either VSTPA assay or syphilis rapid card test and the syphilis reactivity rate was compared between both assays. Results: While screening with syphilis rapid card test, the percentage of reactivity observed was 0.36% whereas with VSTPA assay, the reactivity was increased to 0.87%. As per the CDC reverse sequence algorithm, the seroreactive samples in VSTPA assay were subjected to nontreponemal RPR test. The discordant samples which showed “nonreactive” in RPR assay were sent for syphilis confirmatory test based on fluorescent treponemal antibody absorption (FTA-ABS) test. In the reverse algorithm study, 40% of samples with discordant results were confirmed as “Positive” in FTA-ABS test confirming the superior sensitivity of VSTPA assay over nontreponemal RPR assay as well as treponemal syphilis rapid card test. Conclusion: Automation of syphilis screening using VSTPA assay helps in consolidation of the assay with other transfusion transmittable infections, namely, HIV, HBsAg, and anti-HCV screening assay on chemiluminescence platform which is highly valuable for optimizing workflow, efficiency with excellent sensitivity, and reliable specificity.
topic Centers for Disease Control and Prevention
nontreponemal test
reverse sequence algorithm
syphilis
treponemal test
VITROS Syphilis Treponema pallidum agglutination
url http://www.gjtmonline.com/article.asp?issn=2468-8398;year=2019;volume=4;issue=1;spage=69;epage=73;aulast=Pathak
work_keys_str_mv AT amardeeppathak performanceevaluationofvitrossyphilistreponemapallidumagglutinationassayinblooddonorsamplesbyusingcentersfordiseasecontrolandpreventionreversesequencealgorithm
AT manushrisharma performanceevaluationofvitrossyphilistreponemapallidumagglutinationassayinblooddonorsamplesbyusingcentersfordiseasecontrolandpreventionreversesequencealgorithm
AT narendertejwani performanceevaluationofvitrossyphilistreponemapallidumagglutinationassayinblooddonorsamplesbyusingcentersfordiseasecontrolandpreventionreversesequencealgorithm
AT anuragmehta performanceevaluationofvitrossyphilistreponemapallidumagglutinationassayinblooddonorsamplesbyusingcentersfordiseasecontrolandpreventionreversesequencealgorithm
_version_ 1725311171837296640