Evaluation of a Rapid Point-of-Care Multiplex Immunochromatographic Assay for the Diagnosis of Enteric Fever

ABSTRACT There is a critical need for an improved rapid diagnostic for enteric fever. We have previously demonstrated that serum IgA responses targeting Salmonella enterica serovar Typhi hemolysin E (HlyE) and lipopolysaccharide (LPS) are able to discriminate patients with acute typhoid from healthy...

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Autores principales:	Shailendra Kumar, Ariana Nodoushani, Farhana Khanam, Alyssa T. DeCruz, Paul Lambotte, Robert Scott, Isaac I. Bogoch, Krista Vaidya, Stephen B. Calderwood, Taufiqur R. Bhuiyan, Javan Esfandiari, Edward T. Ryan, Firdausi Qadri, Jason R. Andrews, Richelle C. Charles
Formato:	article
Lenguaje:	EN
Publicado:	American Society for Microbiology 2020
Materias:	S. Paratyphi A S. Typhi Salmonella diagnostic enteric fever paratyphoid Microbiology QR1-502
Acceso en línea:	https://doaj.org/article/e50356d28aa640eba3c55df4f6956baf
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spelling	oai:doaj.org-article:e50356d28aa640eba3c55df4f6956baf2021-11-15T15:30:15ZEvaluation of a Rapid Point-of-Care Multiplex Immunochromatographic Assay for the Diagnosis of Enteric Fever10.1128/mSphere.00253-202379-5042https://doaj.org/article/e50356d28aa640eba3c55df4f6956baf2020-06-01T00:00:00Zhttps://journals.asm.org/doi/10.1128/mSphere.00253-20https://doaj.org/toc/2379-5042ABSTRACT There is a critical need for an improved rapid diagnostic for enteric fever. We have previously demonstrated that serum IgA responses targeting Salmonella enterica serovar Typhi hemolysin E (HlyE) and lipopolysaccharide (LPS) are able to discriminate patients with acute typhoid from healthy controls in areas where enteric fever is endemic (healthy endemic controls) and from patients with other bacterial infections. We now have data demonstrating that IgA antibody responses against these antigens also work well for identifying patients with acute S. Paratyphi A infection. To develop a test for acute enteric fever detection, we have adapted a point-of-care immunochromatographic dual-path platform technology (DPP), which improves on the traditional lateral flow technology by using separate sample and conjugate paths and a compact, portable reader, resulting in diagnostics with higher sensitivity and multiplexing abilities. In this analysis, we have compared our standard enzyme-linked immunosorbent assay (ELISA) method to the DPP method in detecting acute phase plasma/serum anti-HlyE and anti-LPS IgA antibodies in a cohort of patients with culture-confirmed S. Typhi (n = 30) and Paratyphi A infection (n = 20), healthy endemic controls (n = 25), and febrile endemic controls (n = 25). We found that the DPP measurements highly correlated with ELISA results, and both antigens had an area under the curve (AUC) of 0.98 (sensitivity of 92%, specificity of 94%) with all controls and an AUC of 0.98 (sensitivity of 90%, specificity of 96%) with febrile endemic controls. Our results suggest that the point-of-care DPP Typhoid System has high diagnostic accuracy for the rapid detection of enteric fever and warrants further evaluation. IMPORTANCE Enteric fever remains a significant global problem, and control programs are significantly limited by the lack of an optimal assay for identifying individuals with acute infection. This is especially critical considering the recently released World Health Organization (WHO) position paper endorsing the role of the typhoid conjugate vaccine in communities where enteric fever is endemic. A reliable diagnostic test is needed to assess and evaluate typhoid intervention strategies and determine which high-burden areas may benefit most from a vaccine intervention. Our collaborative team has developed and evaluated a point-of-care serodiagnostic assay based on detection of anti-HlyE and LPS IgA. Our finding of the high diagnostic accuracy of the DPP Typhoid System for the rapid detection of enteric fever has the potential to have significant public health impact by allowing for improved surveillance and for control and prevention programs in areas with limited laboratory capacity.Shailendra KumarAriana NodoushaniFarhana KhanamAlyssa T. DeCruzPaul LambotteRobert ScottIsaac I. BogochKrista VaidyaStephen B. CalderwoodTaufiqur R. BhuiyanJavan EsfandiariEdward T. RyanFirdausi QadriJason R. AndrewsRichelle C. CharlesAmerican Society for MicrobiologyarticleS. Paratyphi AS. TyphiSalmonelladiagnosticenteric feverparatyphoidMicrobiologyQR1-502ENmSphere, Vol 5, Iss 3 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	S. Paratyphi A S. Typhi Salmonella diagnostic enteric fever paratyphoid Microbiology QR1-502
spellingShingle	S. Paratyphi A S. Typhi Salmonella diagnostic enteric fever paratyphoid Microbiology QR1-502 Shailendra Kumar Ariana Nodoushani Farhana Khanam Alyssa T. DeCruz Paul Lambotte Robert Scott Isaac I. Bogoch Krista Vaidya Stephen B. Calderwood Taufiqur R. Bhuiyan Javan Esfandiari Edward T. Ryan Firdausi Qadri Jason R. Andrews Richelle C. Charles Evaluation of a Rapid Point-of-Care Multiplex Immunochromatographic Assay for the Diagnosis of Enteric Fever
description	ABSTRACT There is a critical need for an improved rapid diagnostic for enteric fever. We have previously demonstrated that serum IgA responses targeting Salmonella enterica serovar Typhi hemolysin E (HlyE) and lipopolysaccharide (LPS) are able to discriminate patients with acute typhoid from healthy controls in areas where enteric fever is endemic (healthy endemic controls) and from patients with other bacterial infections. We now have data demonstrating that IgA antibody responses against these antigens also work well for identifying patients with acute S. Paratyphi A infection. To develop a test for acute enteric fever detection, we have adapted a point-of-care immunochromatographic dual-path platform technology (DPP), which improves on the traditional lateral flow technology by using separate sample and conjugate paths and a compact, portable reader, resulting in diagnostics with higher sensitivity and multiplexing abilities. In this analysis, we have compared our standard enzyme-linked immunosorbent assay (ELISA) method to the DPP method in detecting acute phase plasma/serum anti-HlyE and anti-LPS IgA antibodies in a cohort of patients with culture-confirmed S. Typhi (n = 30) and Paratyphi A infection (n = 20), healthy endemic controls (n = 25), and febrile endemic controls (n = 25). We found that the DPP measurements highly correlated with ELISA results, and both antigens had an area under the curve (AUC) of 0.98 (sensitivity of 92%, specificity of 94%) with all controls and an AUC of 0.98 (sensitivity of 90%, specificity of 96%) with febrile endemic controls. Our results suggest that the point-of-care DPP Typhoid System has high diagnostic accuracy for the rapid detection of enteric fever and warrants further evaluation. IMPORTANCE Enteric fever remains a significant global problem, and control programs are significantly limited by the lack of an optimal assay for identifying individuals with acute infection. This is especially critical considering the recently released World Health Organization (WHO) position paper endorsing the role of the typhoid conjugate vaccine in communities where enteric fever is endemic. A reliable diagnostic test is needed to assess and evaluate typhoid intervention strategies and determine which high-burden areas may benefit most from a vaccine intervention. Our collaborative team has developed and evaluated a point-of-care serodiagnostic assay based on detection of anti-HlyE and LPS IgA. Our finding of the high diagnostic accuracy of the DPP Typhoid System for the rapid detection of enteric fever has the potential to have significant public health impact by allowing for improved surveillance and for control and prevention programs in areas with limited laboratory capacity.
format	article
author	Shailendra Kumar Ariana Nodoushani Farhana Khanam Alyssa T. DeCruz Paul Lambotte Robert Scott Isaac I. Bogoch Krista Vaidya Stephen B. Calderwood Taufiqur R. Bhuiyan Javan Esfandiari Edward T. Ryan Firdausi Qadri Jason R. Andrews Richelle C. Charles
author_facet	Shailendra Kumar Ariana Nodoushani Farhana Khanam Alyssa T. DeCruz Paul Lambotte Robert Scott Isaac I. Bogoch Krista Vaidya Stephen B. Calderwood Taufiqur R. Bhuiyan Javan Esfandiari Edward T. Ryan Firdausi Qadri Jason R. Andrews Richelle C. Charles
author_sort	Shailendra Kumar
title	Evaluation of a Rapid Point-of-Care Multiplex Immunochromatographic Assay for the Diagnosis of Enteric Fever
title_short	Evaluation of a Rapid Point-of-Care Multiplex Immunochromatographic Assay for the Diagnosis of Enteric Fever
title_full	Evaluation of a Rapid Point-of-Care Multiplex Immunochromatographic Assay for the Diagnosis of Enteric Fever
title_fullStr	Evaluation of a Rapid Point-of-Care Multiplex Immunochromatographic Assay for the Diagnosis of Enteric Fever
title_full_unstemmed	Evaluation of a Rapid Point-of-Care Multiplex Immunochromatographic Assay for the Diagnosis of Enteric Fever
title_sort	evaluation of a rapid point-of-care multiplex immunochromatographic assay for the diagnosis of enteric fever
publisher	American Society for Microbiology
publishDate	2020
url	https://doaj.org/article/e50356d28aa640eba3c55df4f6956baf
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Evaluation of a Rapid Point-of-Care Multiplex Immunochromatographic Assay for the Diagnosis of Enteric Fever

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