ISDS Annual Conference Proceedings 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution-
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ISDS 2015 Conference Abstracts

Product Landscape of Rapid Diagnostic Tests for Viral 
Hemorrhagic Fever Pathogens
Noah Hull*2, Andrew Hickey1 and Teresa Quitugua1
1National Biosurveillance Integration Center, Office of Health Affairs, United States Department of Homeland Security, Washington, 
DC, USA; 2University of Wyoming, Laramie, WY, USA

Objective
Provide a succinct review of potential developmental and 

commercial viral hemorrhagic fever diagnostic assays published in 
peer-reviewed literature and open-source platforms.

Introduction
As the lead for coordinating domestic incident management across 

all Federal departments and agencies, Department of Homeland 
Security is responsible for identifying emergency response resources. 
The 2014 Ebola – Zaire outbreak in West Africa that became a Public 
Health Emergency of International Concern highlighted the need 
to understand the current and potential availability of diagnostic 
assays for a number of viral hemorrhagic fevers that may require 
similar response actions. A concatenated list of publically reported 
potential viral hemorrhagic fever diagnostic assays was therefore 
compiled. Etiologic agents in the families of Arena-, Bunya-, Filo-, 
and Flaviviridae were included in the analysis. This list identifies 
assays in various stages of development that could be submitted, at 
some point, to the Food and Drug Administration (FDA) under an 
Emergency Use Authorization (EUA) should such a need arise.

Methods
Boolean logic formatted searches were conducted using PubMed, 

Google Scholar, and Google to identify open-source reports of 
diagnostic assays for viral hemorrhagic fevers. The general Boolean 
search term was [(PATHOGEN OF INTEREST AND Diagnostic) 
(Rapid OR Point of Care OR “Assay Development” OR Validation 
OR POC OR Evaluation OR Clinical OR Deploy* OR Testing OR 
Detect*)]. Returned results were screened for data elements that 
provided adequate information to derive test performance statistics 
(limit of detection, sensitivity with 95% confidence interval, 
specificity with 95% confidence interval, positive predictive value, 
and negative predictive value). Assays were qualitatively analyzed 
based on limit of detection, sensitivity, and specificity estimates. 
Genus level etiologic agents by family are: Arenaviridae (Chapare, 
Guanarito, Junin, Lassa, Lujo, Lymphocytic choriomennigitis, 
Machupo, Sabia, and Whitewater Arroyo), Bunyaviridae (Crimean-
Congo, Hantavirus, and Rift Valley Fever), Filoviridae (Ebola and 
Marburg), and Flaviviridae (Dengue, Kyasanur Forest Disease, 
Omsk, and Yellow Fever).

Results
Through the use of the Boolean logic, 312 unique assay data 

sources were identified and examined. One hundred seventeen sources 
contained adequate information to derive diagnostic test statistics 
for examination as part of this review. Inadequate information was 
identified for Chapare Hemorrhagic Fever, Whitewater Arroyo Virus, 
and Omsk Hemorrhagic Fever, so diagnostic information for these 
agents was not included in the final table. Assays were dichotomized 
as either academic/government or commercial assays. Of the 212 total 
assays, 136 (64%) resided in academic or government laboratories. 
Of those, the vast majority addressed the Arena-, Bunya-, and 
Filoviridae families (35%, 34%, and 26% respectively), compared to 
the commercial assays addressing the Filo- and Bunyaviridae families 

(43% and 27.6% respectively). The disproportionate weight of the 
commercial assays on Filoviridae is likely a function of the 2014 
Ebola-Zaire outbreak. In the academic/government validated assays, 
82% were validated on clinically derived samples, in comparison to 
57% from the commercial assays. Clinically validated assays are the 
“gold-standard” validation technique as recommended by the FDA.

Conclusions
The potential product landscape for rapid diagnostics of viral 

hemorrhagic fevers is extensive. However, the vast majority of these 
assays were developed in academic or government laboratories and 
have not progressed further toward commercialization or broad 
public health use. Subsequently, should an EUA be sought for these 
diagnostic assays, their approval may be delayed due to the lack of 
validation and standardization required for deployment as a reliable 
diagnostic tool. Lastly, the validation methods by which each assay 
was tested varied greatly, resulting in difficultly drawing direct 
comparisons amongst assays.

Keywords
Viral Hemorrhagic Fever; Diagnostic Test; Product Landscape

Acknowledgments
This material is based upon work supported by the United States 
Department of Homeland Security - Office of Health Affairs - Volunteer 
Scholar Program and by the United States Department of Homeland 
Security under Cooperative Agreement Number DHS 2010-ST-
061-AG002.

*Noah Hull
E-mail: Nhull@uab.edu    

Online Journal of Public Health Informatics * ISSN 1947-2579 * http://ojphi.org * 8(1):e123, 2016 


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	Julie A. Pavlin*1, Gosia Nowak2, Aaron Kite-Powell3, Lindsey Beaman1 and Timothy Whitman4

	Prospective Spatio-Temporal and Temporal Cluster Detection by Salmonella Serotype
	Eric R. Peterson*, Vasudha Reddy, HaeNa Waechter, Lan Li, Kristen Forney and Sharon K. Greene

	Factors Influencing the Stability and Quality of the French ED Surveillance System
	Isabelle Pontais*, Vanina Bousquet, Marc Ruello, Céline Caserio-Schönemann and Anne Fouillet

	Monitoring Media Content About Vaccines in the United States: Data from the Vaccine Sentimeter
	Guido A. Powell*1, Kate Zinszer1, Aman D. Verma1, Lawrence C. Madoff3, Chi Bahk2, John S. Brownstein4 and David Buckeridge1

	Law, Policy, and Syndromic Disease Surveillance: A Multi-Site Case Study
	Jonathan Purtle*2, Robert Field1, Esther Chernak1, Tom Hipper1 and Jillian Nash1

	Susceptibility Profile of Drug-Resistant Streptococcus pneumoniae Based on ELR
	Avi Raju*, Eunice R. Santos, Eric V. Bakota, Biru Yang and Raouf R. Arafat

	Predicting Facility-Level Carbapenem-Resistant Enterobacteriaceae (CRE) Incidence Based on Social Network Measures
	Michael J. Ray*1, Michael Y. Lin2 and William Trick2

	The Public Health Community Platform: Implementing Electronic Case Reporting
	Marcus Rennick*, Scott Gordon, Monica Huang, Mark Sum and Paula Soper

	An R Script for Assessment of Data Quality in the BioSense Locker Database
	Serena Rezny* and Stacey Hoferka

	Characterizing Public Health Actions in Response to Syndromic Surveillance Alerts
	Laura Rivera1, Rachel Savage2, Natasha Crowcroft1, 2, Laura Rosella2, 1, Li Ye1, 2, Shelly Bolotin1, 2, Wendy Lou1 and Ian Johnson*1, 2

	The Impact of Standardized Decision Support on Syndromic Surveillance in Alberta
	Laura Rivera1, Faiza Habib3, Ye Li1, 2, Rita K. Biel3, Rachel Savage2, Natasha Crowcroft1, 2, Laura Rosella2, 1, Shelly Bolotin1, 2, David Strong3, 4, Christopher Sikora3, 5 and Ian Johnson*1, 2

	Syndromic Surveillance Evaluation of Influenza Activity in At-Risk Sub-Populations
	Heather Rubino*, Janet J. Hamilton, Allison B. Culpepper, Hunter Davis, David Atrubin and Melissa Murray Jordan

	Epidemic Situation in Ukraine Related to the Quality of Drinking Water
	Iryna Rudenko*

	Acute Gastroenteritis: Contribution of SOS Médecins Network
	Marc Ruello*1, Benjamin Larras1, Noémie Fortin1, Nathalie Jourdan da-silva1, Pascal Chansard2, Céline Caserio-Schönemann1, Vanina Bousquet1, Anne Fouillet1 and Isabelle Pontais1

	Which Sections of Electronic Medical Records Are Most Relevant for Real-Time Surveillance of Influenza-like Illness?
	Dino P. Rumoro1, Shital C. Shah1, Marilyn M. Hallock1, Gillian S. Gibbs*1, Gordon M. Trenholme1, Michael J. Waddell2 and Joseph P. Bernstein3

	The Impact of Documentation Style on Influenza-Like Illness Rates in the Emergency Department
	Dino P. Rumoro1, Shital C. Shah1, Gillian S. Gibbs*1, Marilyn M. Hallock1, Gordon M. Trenholme1, Michael J. Waddell2 and Joseph P. Bernstein3

	Natural Language Processing and Technical Challenges of Influenza-Like Illness Surveillance
	Dino P. Rumoro1, Gillian S. Gibbs*1, Shital C. Shah1, Marilyn M. Hallock1, Gordon M. Trenholme1, Michael J. Waddell2 and Joseph P. Bernstein3

	One Health e-Surveillance for Early Detection of Gastrointestinal Disease Outbreaks
	Fernando Sánchez-Vizcaíno*1, Barry Rowlingson2, Alan D Radford1, Alison Hale2, Emanuele Giorgi2, Sarah J O’Brien3, Susan Dawson4, Rosalind M Gaskell1, Philip H Jones1, Tarek Menacere1, Peter-John M Noble4, Maya Wardeh1 and Peter Diggle2

	Data Blindspots: High-Tech Disease Surveillance Misses the Poor
	Samuel V. Scarpino*1, James G. Scott2, Rosalind Eggo2, Nedialko B. Dimitrov2 and Lauren A. Meyers2, 1

	A Comparison of Clinical Surveillance Systems in New York City
	Lauren Schreibstein*1, Remle Newton-Dame1, Katharine H. McVeigh1, Sharon E. Perlman1, Lorna E. Thorpe2, Hannah Mandel1 and Michael Buck1

	Monitoring and Evaluation Mechanism for Multi-Center Capacity Building Gestational Diabetes Program for Physicians in India
	Megha Sharma*

	Avian Flu, Ebola, MERS, and Other Emerging Challenges for Influenza Surveillance Practitioners
	Alan Siniscalchi2 and Brooke Evans*1

	HIT Conformance Testing: Advancing Syndromic Surveillance System Interoperability
	Robert Snelick and Sheryl L. Taylor*

	Visualizing the Local Experience: HIV Data to Care Tool
	Lauren E. Snyder*1, Dean McEwen1, Mark Thrun2, 1 and Arthur Davidson1

	Extending an Uncertainty Taxonomy for Suspected Pneumonia Case Review
	Brett R. South*1, 2, Heidi S. Kramer2, Melissa Castine1, Danielle Mowery1, 2, Barbara Jones2 and Wendy Chapman1, 2

	Comparison of Exposure to Risk Factors for Giardiasis Among Endemic and Travel Cases
	Alexandra Swirski*1, David Pearl1, Andrew Peregrine1 and Katarina Pintar2

	African One Health e-Surveillance Initiative
	Joy Sylvester*1, Herbert Kazoora2, Meeyoung Park1, Sheba Gitta2, Betiel H. Haile1 and Scott J. McNabb1

	Strengthening Community Surveillance of Ebola Virus Disease in Sierra Leone
	AnhMinh A. Tran*, Adam Hoar, Alyssa J. Young, Allison Connolly, Mary-Anne Hartley, Samuel Boland, Brooke Mancuso, Guddu Kaur, John Esplana, Erin Polich and Laura Fisher

	Surveillance of Anthrax Foci Across Pipeline Constructions in Georgia, 2003-2014
	Nikoloz Tsertsvadze, Lile Malania, Nato Abazashvili, Julieta Manvelian, Mariam Broladze and Paata Imnadze

	Situational Awareness of Health Events Using Social Media and the SMART Dashboard
	Ming-Hsiang Tsou2, 3, 1, Chin-Te Jung2, 3, 1 and Michael Peddecord*4, 3, 1

	Evaluation of Legionellosis Surveillance in Michigan Focusing on Diagnostic Testing
	Leigh M. Tyndall Snow*1, 2, Veronica A. Fialkowski1, 2 and Mary Grace Stobierski1

	Highway Emergency Response and Accident Mitigation Service (HERAM) – A Field Report
	Balaji Utla*, Dr. Shailendra Kumar B. Hegde, Dr. Sri Ranga Prasad Saride, Dr. Ramanuja Chary Kandaala, Mr. Sridhar Upadhya and Anukrati Saxena

	Enhancing Biosurveillance Specificity Using Praedico™, A Next Generation Application
	Alireza Vahdatpour2, Cynthia A. Lucero-Obusan1, Chris Lee2, Gina Oda1, Patricia Schirmer1, Anosh Mostaghimi1, Farshid Sedghi2, Payam Etminani2 and Mark Holodniy*1

	Biosense and Violence: Progress Toward Violence Prevention Using Syndromic Surveillance
	Jennifer Vahora* and Stacey Hoferka

	Situational Awareness for Unfolding Gastrointestinal Outbreaks Using Historical Data
	Nileena Velappan*, Ashlynn Daughton, Esteban Abeyta, Geoffrey Fairchild, William Rosenberger and Alina Deshpande

	Interest of Prospective Spatio-Temporal Analysis from ED Data to Detect Unusual Health Events
	Pascal Vilain*, Sébastien Cossin and Laurent Filleul

	Using Syndromic Surveillance to Identify Synthetic Cannabinoids or Marijuana Adverse Health Events in Virginia
	Amanda Wahnich*

	Lessons Learned from the Transition to ICD-10-CM: Redefining Syndromic Surveillance Case Definitions for NC DETECT
	Anna E. Waller, Katherine J. Harmon* and Amy Ising

	Automating Ambulatory Practice Surveillance for Influenza-Like Illness
	Andrew Walsh*

	Enhancing EpiCenter Data Quality Analytics with R
	Andrew Walsh*

	Alcohol-Related ED Visits and Ohio State Football: Putting the O-H in ETOH
	Kristen A. Weiss* and Andrew Walsh

	Enhancing Syndromic Surveillance at a Local Public Health Department
	Jessica R. White* and Kate Goodin

	Using Syndromic Surveillance to Enhance Arboviral Surveillance in Arizona
	Jessica R. White*1, Sara Imholte2 and Krystal Collier2

	Evaluating the BioSense Syndrome for Heat-Related Illness in Maricopa County, Arizona
	Jessica R. White*, Kate Goodin and Vjollca Berisha

	Sensitivity and Specificity of the Fever Syndromes in BioSense and ESSENCE
	Caleb Wiedeman*

	Analysis of ED and UCC Visits Related to Synthetic Marijuana in ESSENCE-FL, 2010-2015
	Michael Wiese*1 and Charles R. Clark2

	Comparison of Air Passenger Travel Volume Data Sources for Biosurveillance
	Diana Y. Wong*, Teresa Quitugua and Julie Waters

	A Suggestion to Improve Timely Feedback of Infectious Disease Surveillance Data at a Provincial Level in South Korea
	Seon-ju Yi*, Gichan Park, Hwami Kim, SoYoon Min, Jee soo Suh, Soojung Jo, Daeun Jeong, Young-Man Kim and Heeyoung Lee

	Update on the CDC National Syndromic Surveillance Program
	Paula Yoon and Michael Coletta*

	Use of Peripheral Health Units in Low-Transmission Ebola Virus Disease Surveillance
	Alyssa J. Young*, Allison Connolly, Adam Hoar, Brooke Mancuso, John Mark Esplana, Guddu Kaur, Laura Fisher, Mary-Anne Hartley and Anh-Minh A Tran

	Place Matters: Revealing Infectious Disease Disparities Using Area-Based Poverty
	Kimberly Yousey-Hindes*1, Sharon K. Greene2, Kelley Bemis3 and Kristen Soto4

	Addressing Health Equity Through Data Collection and Linked Disease Surveillance
	Iris Zachary*1, Jeannette Jackson-Thompson1, 2, 3, Emily Leary1 and Eduardo Simoes1, 2, 3

	Epizootology and Molecular Diagnosis of Lumpy Skin Diesease Among Livestock in Azerbaijan
	Shalala K. Zeynalova*

	Exploring Usability of School Closure Data for Influenza-Like Illness Surveillance
	Yenlik Zheteyeva*, Hongjiang Gao, Jianrong Shi and Amra Uzicanin

	Efficient Surveillance of Childhood Diabetes Using Electronic Health Record Data
	Victor W. Zhong*1, Jihad S. Obeid2, Jean B. Craig2, Emily R. Pfaff1, Joan Thomas1, Lindsay M. Jaacks3, Daniel P. Beavers4, Timothy S. Carey1, Jean M. Lawrence5, Dana Dabelea6, Richard F. Hamman6, Deborah A. Bowlby2, Catherine Pihoker7, Sharon H. Saydah8 a