Field Test and Validation of the Multiplier Measles, Mumps, Rubella, and Varicella-Zoster Multiplexed Assay System in the Democratic Republic of the Congo by Using Dried Blood Spots

ABSTRACT Here we describe baseline validation studies and field performance of a research-use-only chemiluminescent multiplex serology panel for measles, mumps, rubella, and varicella-zoster virus used with dried blood spots in support of the 2013–2014 Democratic Republic of the Congo Demographic an...

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Autores principales:	Stephen G. Higgins, Nicole A. Hoff, Adva Gadoth, Andrew Fusellier, Patrick Mukadi, Vivian Alfonso, Christina Randall, Hayley Ashbaugh, Melanie Poncheri, Reena H. Doshi, Sue Gerber, Roger Budd, Robert Wolfert, Russell Williams, Emile Okitolonda-Wemakoy, Jean-Jacque Muyembe-Tamfum, Anne W. Rimoin
Formato:	article
Lenguaje:	EN
Publicado:	American Society for Microbiology 2019
Materias:	Democratic Republic of the Congo MMRV assay validation multiplex assay Microbiology QR1-502
Acceso en línea:	https://doaj.org/article/3e1d5e6d3287431a9b7e264f314dd594
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spelling	oai:doaj.org-article:3e1d5e6d3287431a9b7e264f314dd5942021-11-15T15:22:26ZField Test and Validation of the Multiplier Measles, Mumps, Rubella, and Varicella-Zoster Multiplexed Assay System in the Democratic Republic of the Congo by Using Dried Blood Spots10.1128/mSphere.00112-192379-5042https://doaj.org/article/3e1d5e6d3287431a9b7e264f314dd5942019-08-01T00:00:00Zhttps://journals.asm.org/doi/10.1128/mSphere.00112-19https://doaj.org/toc/2379-5042ABSTRACT Here we describe baseline validation studies and field performance of a research-use-only chemiluminescent multiplex serology panel for measles, mumps, rubella, and varicella-zoster virus used with dried blood spots in support of the 2013–2014 Democratic Republic of the Congo Demographic and Health Survey. Characterization of the panel using U.S. FDA-cleared commercial kits shows good concordance for measles, mumps, rubella, and varicella-zoster with average sensitivity across assays of 94.9% and an average specificity of 91.4%. As expected, performance versus available standards validated for plaque-reduction assays does not provide a 1:1 correspondence with international units and yet demonstrates excellent linearity (average Hill’s slope = 1.02) and ∼4 logs of dynamic range. In addition, for the four assays, the multiplexed format allowed for inclusion of three positive and two negative controls for each sample. A prototype Dynex Multiplier chemiluminescent automated immunoassay instrument with a charge-coupled device camera provided a rugged and robust processing and data acquisition platform. Performance of a multiplex instrument for serological testing in a substantially resource-limited environment shows excellent reproducibility, minimal cross-reactivity, and a clear discrimination between specific assays and should be considered a viable option for future serosurveys. IMPORTANCE The critical evaluation of immunization programs is key to identifying areas of suboptimal vaccination coverage, monitoring activities, and aiding development of public health policy. For evaluation of vaccine effectiveness, direct antibody binding assay methods, including enzyme immunoassay, enzyme-linked fluorescence assays, and indirect immunofluorescence assay, are most commonly used for detection of IgG antibodies. However, despite their well-demonstrated, reliable performance, they can be labor-intensive and time-consuming and require separate assays for each individual marker. This necessitates increased sample volumes, processing time, and personnel, which may limit assessment to a few key targets in resource-limited settings, that is, low- and middle-income locations where funding for public health or general infrastructure that directly impacts public health is restricted, limiting access to equipment, infrastructure, and trained personnel. One solution is a multiplexed immunoassay, which allows for the detection of multiple analytes in a single reaction for increased efficiency and rapid surveillance of infectious diseases in limited-resource settings. Thus, the scope of the project precluded a full validation, and here we present abbreviated validation studies demonstrating adequate sensitivity, specificity, and reproducibility.Stephen G. HigginsNicole A. HoffAdva GadothAndrew FusellierPatrick MukadiVivian AlfonsoChristina RandallHayley AshbaughMelanie PoncheriReena H. DoshiSue GerberRoger BuddRobert WolfertRussell WilliamsEmile Okitolonda-WemakoyJean-Jacque Muyembe-TamfumAnne W. RimoinAmerican Society for MicrobiologyarticleDemocratic Republic of the CongoMMRVassay validationmultiplex assayMicrobiologyQR1-502ENmSphere, Vol 4, Iss 4 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	Democratic Republic of the Congo MMRV assay validation multiplex assay Microbiology QR1-502
spellingShingle	Democratic Republic of the Congo MMRV assay validation multiplex assay Microbiology QR1-502 Stephen G. Higgins Nicole A. Hoff Adva Gadoth Andrew Fusellier Patrick Mukadi Vivian Alfonso Christina Randall Hayley Ashbaugh Melanie Poncheri Reena H. Doshi Sue Gerber Roger Budd Robert Wolfert Russell Williams Emile Okitolonda-Wemakoy Jean-Jacque Muyembe-Tamfum Anne W. Rimoin Field Test and Validation of the Multiplier Measles, Mumps, Rubella, and Varicella-Zoster Multiplexed Assay System in the Democratic Republic of the Congo by Using Dried Blood Spots
description	ABSTRACT Here we describe baseline validation studies and field performance of a research-use-only chemiluminescent multiplex serology panel for measles, mumps, rubella, and varicella-zoster virus used with dried blood spots in support of the 2013–2014 Democratic Republic of the Congo Demographic and Health Survey. Characterization of the panel using U.S. FDA-cleared commercial kits shows good concordance for measles, mumps, rubella, and varicella-zoster with average sensitivity across assays of 94.9% and an average specificity of 91.4%. As expected, performance versus available standards validated for plaque-reduction assays does not provide a 1:1 correspondence with international units and yet demonstrates excellent linearity (average Hill’s slope = 1.02) and ∼4 logs of dynamic range. In addition, for the four assays, the multiplexed format allowed for inclusion of three positive and two negative controls for each sample. A prototype Dynex Multiplier chemiluminescent automated immunoassay instrument with a charge-coupled device camera provided a rugged and robust processing and data acquisition platform. Performance of a multiplex instrument for serological testing in a substantially resource-limited environment shows excellent reproducibility, minimal cross-reactivity, and a clear discrimination between specific assays and should be considered a viable option for future serosurveys. IMPORTANCE The critical evaluation of immunization programs is key to identifying areas of suboptimal vaccination coverage, monitoring activities, and aiding development of public health policy. For evaluation of vaccine effectiveness, direct antibody binding assay methods, including enzyme immunoassay, enzyme-linked fluorescence assays, and indirect immunofluorescence assay, are most commonly used for detection of IgG antibodies. However, despite their well-demonstrated, reliable performance, they can be labor-intensive and time-consuming and require separate assays for each individual marker. This necessitates increased sample volumes, processing time, and personnel, which may limit assessment to a few key targets in resource-limited settings, that is, low- and middle-income locations where funding for public health or general infrastructure that directly impacts public health is restricted, limiting access to equipment, infrastructure, and trained personnel. One solution is a multiplexed immunoassay, which allows for the detection of multiple analytes in a single reaction for increased efficiency and rapid surveillance of infectious diseases in limited-resource settings. Thus, the scope of the project precluded a full validation, and here we present abbreviated validation studies demonstrating adequate sensitivity, specificity, and reproducibility.
format	article
author	Stephen G. Higgins Nicole A. Hoff Adva Gadoth Andrew Fusellier Patrick Mukadi Vivian Alfonso Christina Randall Hayley Ashbaugh Melanie Poncheri Reena H. Doshi Sue Gerber Roger Budd Robert Wolfert Russell Williams Emile Okitolonda-Wemakoy Jean-Jacque Muyembe-Tamfum Anne W. Rimoin
author_facet	Stephen G. Higgins Nicole A. Hoff Adva Gadoth Andrew Fusellier Patrick Mukadi Vivian Alfonso Christina Randall Hayley Ashbaugh Melanie Poncheri Reena H. Doshi Sue Gerber Roger Budd Robert Wolfert Russell Williams Emile Okitolonda-Wemakoy Jean-Jacque Muyembe-Tamfum Anne W. Rimoin
author_sort	Stephen G. Higgins
title	Field Test and Validation of the Multiplier Measles, Mumps, Rubella, and Varicella-Zoster Multiplexed Assay System in the Democratic Republic of the Congo by Using Dried Blood Spots
title_short	Field Test and Validation of the Multiplier Measles, Mumps, Rubella, and Varicella-Zoster Multiplexed Assay System in the Democratic Republic of the Congo by Using Dried Blood Spots
title_full	Field Test and Validation of the Multiplier Measles, Mumps, Rubella, and Varicella-Zoster Multiplexed Assay System in the Democratic Republic of the Congo by Using Dried Blood Spots
title_fullStr	Field Test and Validation of the Multiplier Measles, Mumps, Rubella, and Varicella-Zoster Multiplexed Assay System in the Democratic Republic of the Congo by Using Dried Blood Spots
title_full_unstemmed	Field Test and Validation of the Multiplier Measles, Mumps, Rubella, and Varicella-Zoster Multiplexed Assay System in the Democratic Republic of the Congo by Using Dried Blood Spots
title_sort	field test and validation of the multiplier measles, mumps, rubella, and varicella-zoster multiplexed assay system in the democratic republic of the congo by using dried blood spots
publisher	American Society for Microbiology
publishDate	2019
url	https://doaj.org/article/3e1d5e6d3287431a9b7e264f314dd594
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Field Test and Validation of the Multiplier Measles, Mumps, Rubella, and Varicella-Zoster Multiplexed Assay System in the Democratic Republic of the Congo by Using Dried Blood Spots

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