Monitoring temporal changes in the specificity of an oral HIV test: a novel application for use in postmarketing surveillance.

<h4>Background</h4>Postmarketing surveillance is routinely conducted to monitor performance of pharmaceuticals and testing devices in the marketplace. However, these surveillance methods are often done retrospectively and, as a result, are not designed to detect issues with performance i...

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Autores principales:	Joseph R Egger, Kevin J Konty, Jessica M Borrelli, Julia Cummiskey, Susan Blank
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2010
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/7e84f4f1727f4fcf9b36f2ba50c0b343
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spelling	oai:doaj.org-article:7e84f4f1727f4fcf9b36f2ba50c0b3432021-11-18T06:35:45ZMonitoring temporal changes in the specificity of an oral HIV test: a novel application for use in postmarketing surveillance.1932-620310.1371/journal.pone.0012231https://doaj.org/article/7e84f4f1727f4fcf9b36f2ba50c0b3432010-08-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/20811502/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>Postmarketing surveillance is routinely conducted to monitor performance of pharmaceuticals and testing devices in the marketplace. However, these surveillance methods are often done retrospectively and, as a result, are not designed to detect issues with performance in real-time.<h4>Methods and findings</h4>Using HIV antibody screening test data from New York City STD clinics, we developed a formal, statistical method of prospectively detecting temporal clusters of poor performance of a screening test. From 2005 to 2008, New York City, as well as other states, observed unexpectedly high false-positive (FP) rates in an oral fluid-based rapid test used for screening HIV. We attempted to formally assess whether the performance of this HIV screening test statistically deviated from both local expectation and the manufacturer's claim for the test. Results indicate that there were two significant temporal clusters in the FP rate of the oral HIV test, both of which exceeded the manufacturer's upper limit of the 95% CI for the product. Furthermore, the FP rate of the test varied significantly by both STD clinic and test lot, though not by test operator.<h4>Conclusions</h4>Continuous monitoring of surveillance data has the benefit of providing information regarding test performance, and if conducted in real-time, it can enable programs to examine reasons for poor test performance in close proximity to the occurrence. Techniques used in this study could be a valuable addition for postmarketing surveillance of test performance and may become particularly important with the increase in rapid testing methods.Joseph R EggerKevin J KontyJessica M BorrelliJulia CummiskeySusan BlankPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 5, Iss 8, p e12231 (2010)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Joseph R Egger Kevin J Konty Jessica M Borrelli Julia Cummiskey Susan Blank Monitoring temporal changes in the specificity of an oral HIV test: a novel application for use in postmarketing surveillance.
description	<h4>Background</h4>Postmarketing surveillance is routinely conducted to monitor performance of pharmaceuticals and testing devices in the marketplace. However, these surveillance methods are often done retrospectively and, as a result, are not designed to detect issues with performance in real-time.<h4>Methods and findings</h4>Using HIV antibody screening test data from New York City STD clinics, we developed a formal, statistical method of prospectively detecting temporal clusters of poor performance of a screening test. From 2005 to 2008, New York City, as well as other states, observed unexpectedly high false-positive (FP) rates in an oral fluid-based rapid test used for screening HIV. We attempted to formally assess whether the performance of this HIV screening test statistically deviated from both local expectation and the manufacturer's claim for the test. Results indicate that there were two significant temporal clusters in the FP rate of the oral HIV test, both of which exceeded the manufacturer's upper limit of the 95% CI for the product. Furthermore, the FP rate of the test varied significantly by both STD clinic and test lot, though not by test operator.<h4>Conclusions</h4>Continuous monitoring of surveillance data has the benefit of providing information regarding test performance, and if conducted in real-time, it can enable programs to examine reasons for poor test performance in close proximity to the occurrence. Techniques used in this study could be a valuable addition for postmarketing surveillance of test performance and may become particularly important with the increase in rapid testing methods.
format	article
author	Joseph R Egger Kevin J Konty Jessica M Borrelli Julia Cummiskey Susan Blank
author_facet	Joseph R Egger Kevin J Konty Jessica M Borrelli Julia Cummiskey Susan Blank
author_sort	Joseph R Egger
title	Monitoring temporal changes in the specificity of an oral HIV test: a novel application for use in postmarketing surveillance.
title_short	Monitoring temporal changes in the specificity of an oral HIV test: a novel application for use in postmarketing surveillance.
title_full	Monitoring temporal changes in the specificity of an oral HIV test: a novel application for use in postmarketing surveillance.
title_fullStr	Monitoring temporal changes in the specificity of an oral HIV test: a novel application for use in postmarketing surveillance.
title_full_unstemmed	Monitoring temporal changes in the specificity of an oral HIV test: a novel application for use in postmarketing surveillance.
title_sort	monitoring temporal changes in the specificity of an oral hiv test: a novel application for use in postmarketing surveillance.
publisher	Public Library of Science (PLoS)
publishDate	2010
url	https://doaj.org/article/7e84f4f1727f4fcf9b36f2ba50c0b343
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Monitoring temporal changes in the specificity of an oral HIV test: a novel application for use in postmarketing surveillance.

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