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Does performance and operational superiority of point-of-care test make it the investigation of choice in confirming syphilis?

BACKGROUND: According to the World Health Organization, 6 million cases of syphilis occur every year. Serological tests for syphilis form the mainstay of diagnosis for syphilis. We evaluated the performance of point-of-care test (POCT) against other specific treponemal test for confirming the diagno...

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Autores principales: Bhargava, Aradhana, Nagia, Sonal, Verma, Prashant, Bansal, Shikha, Khnuger, Niti, Saxena, Ashok
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9891019/
https://www.ncbi.nlm.nih.gov/pubmed/36743121
http://dx.doi.org/10.4103/ijstd.ijstd_30_22
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author Bhargava, Aradhana
Nagia, Sonal
Verma, Prashant
Bansal, Shikha
Khnuger, Niti
Saxena, Ashok
author_facet Bhargava, Aradhana
Nagia, Sonal
Verma, Prashant
Bansal, Shikha
Khnuger, Niti
Saxena, Ashok
author_sort Bhargava, Aradhana
collection PubMed
description BACKGROUND: According to the World Health Organization, 6 million cases of syphilis occur every year. Serological tests for syphilis form the mainstay of diagnosis for syphilis. We evaluated the performance of point-of-care test (POCT) against other specific treponemal test for confirming the diagnosis of syphilis. MATERIALS AND METHODS: Does performance and operational superiority of POCT make it the investigation of choice in confirming syphilis? Retrospectively, data were analyzed of 599 serum samples from Apex Regional sexually transmitted disease centre, Safdarjung Hospital, New Delhi, received for testing by syphilis treponemal assays (both nontreponemal reactive and nonreactive). These samples underwent treponemal testing for syphilis by the Treponema pallidum hemagglutination (TPHA), fluorescent treponemal antibody absorption test (FTA-ABS), and POCT. Performance characteristics (sensitivity, specificity, positive predictive value [PPV], negative predictive value [NPV], and diagnostic accuracy), and operational characteristics of POCT and TPHA were evaluated against the gold standard FTA-ABS. RESULTS: A total of 599 samples were evaluated, of which 61.76% were positive by FTA-ABS. On analysis, the sensitivity was 91.08% and 91.89%, specificity was 89.08% and 87.34%, PPV was 93.09% and 92.14%, NPV was 86.08% and 86.96%, and diagnostic accuracy was 90.32% and 90.15% for POCT and TPHA, respectively. The lower cost, shorter turnaround time, lesser infrastructure and workforce need, and easy availability make the POCT operationally superior to TPHA. CONCLUSION: Owing to its operational superiority and higher specificity POCT can replace TPHA for confirming the diagnosis of Syphilis. POCT are affordable, equipment free, have room temperature storage, and yield result within 15 minutes, enabling same day testing and treatment. It can be used in a resource limited setting, for community setup or even self-testing.
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spelling pubmed-98910192023-02-02 Does performance and operational superiority of point-of-care test make it the investigation of choice in confirming syphilis? Bhargava, Aradhana Nagia, Sonal Verma, Prashant Bansal, Shikha Khnuger, Niti Saxena, Ashok Indian J Sex Transm Dis AIDS Original Article BACKGROUND: According to the World Health Organization, 6 million cases of syphilis occur every year. Serological tests for syphilis form the mainstay of diagnosis for syphilis. We evaluated the performance of point-of-care test (POCT) against other specific treponemal test for confirming the diagnosis of syphilis. MATERIALS AND METHODS: Does performance and operational superiority of POCT make it the investigation of choice in confirming syphilis? Retrospectively, data were analyzed of 599 serum samples from Apex Regional sexually transmitted disease centre, Safdarjung Hospital, New Delhi, received for testing by syphilis treponemal assays (both nontreponemal reactive and nonreactive). These samples underwent treponemal testing for syphilis by the Treponema pallidum hemagglutination (TPHA), fluorescent treponemal antibody absorption test (FTA-ABS), and POCT. Performance characteristics (sensitivity, specificity, positive predictive value [PPV], negative predictive value [NPV], and diagnostic accuracy), and operational characteristics of POCT and TPHA were evaluated against the gold standard FTA-ABS. RESULTS: A total of 599 samples were evaluated, of which 61.76% were positive by FTA-ABS. On analysis, the sensitivity was 91.08% and 91.89%, specificity was 89.08% and 87.34%, PPV was 93.09% and 92.14%, NPV was 86.08% and 86.96%, and diagnostic accuracy was 90.32% and 90.15% for POCT and TPHA, respectively. The lower cost, shorter turnaround time, lesser infrastructure and workforce need, and easy availability make the POCT operationally superior to TPHA. CONCLUSION: Owing to its operational superiority and higher specificity POCT can replace TPHA for confirming the diagnosis of Syphilis. POCT are affordable, equipment free, have room temperature storage, and yield result within 15 minutes, enabling same day testing and treatment. It can be used in a resource limited setting, for community setup or even self-testing. Wolters Kluwer - Medknow 2022 2022-08-01 /pmc/articles/PMC9891019/ /pubmed/36743121 http://dx.doi.org/10.4103/ijstd.ijstd_30_22 Text en Copyright: © 2022 Indian Journal of Sexually Transmitted Diseases and AIDS https://creativecommons.org/licenses/by-nc-sa/4.0/This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
spellingShingle Original Article
Bhargava, Aradhana
Nagia, Sonal
Verma, Prashant
Bansal, Shikha
Khnuger, Niti
Saxena, Ashok
Does performance and operational superiority of point-of-care test make it the investigation of choice in confirming syphilis?
title Does performance and operational superiority of point-of-care test make it the investigation of choice in confirming syphilis?
title_full Does performance and operational superiority of point-of-care test make it the investigation of choice in confirming syphilis?
title_fullStr Does performance and operational superiority of point-of-care test make it the investigation of choice in confirming syphilis?
title_full_unstemmed Does performance and operational superiority of point-of-care test make it the investigation of choice in confirming syphilis?
title_short Does performance and operational superiority of point-of-care test make it the investigation of choice in confirming syphilis?
title_sort does performance and operational superiority of point-of-care test make it the investigation of choice in confirming syphilis?
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9891019/
https://www.ncbi.nlm.nih.gov/pubmed/36743121
http://dx.doi.org/10.4103/ijstd.ijstd_30_22
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