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Development of an antigen detection assay for early point-of-care diagnosis of Zaire ebolavirus
- Source :
- PLoS Neglected Tropical Diseases, Vol 14, Iss 11, p e0008817 (2020), PLoS Neglected Tropical Diseases
- Publication Year :
- 2020
- Publisher :
- Public Library of Science (PLoS), 2020.
-
Abstract
- The 2013–2016 Ebola virus (EBOV) outbreak in West Africa and the ongoing cases in the Democratic Republic of the Congo have spurred development of a number of medical countermeasures, including rapid Ebola diagnostic tests. The likelihood of transmission increases as the disease progresses due to increasing viral load and potential for contact with others. Early diagnosis of EBOV is essential for halting spread of the disease. Polymerase chain reaction assays are the gold standard for diagnosing Ebola virus disease (EVD), however, they rely on infrastructure and trained personnel that are not available in most resource-limited settings. Rapid diagnostic tests that are capable of detecting virus with reliable sensitivity need to be made available for use in austere environments where laboratory testing is not feasible. The goal of this study was to produce candidate lateral flow immunoassay (LFI) prototypes specific to the EBOV glycoprotein and viral matrix protein, both targets known to be present during EVD. The LFI platform utilizes antibody-based technology to capture and detect targets and is well suited to the needs of EVD diagnosis as it can be performed at the point-of-care, requires no cold chain, provides results in less than twenty minutes and is low cost. Monoclonal antibodies were isolated, characterized and evaluated in the LFI platform. Top performing LFI prototypes were selected, further optimized and confirmed for sensitivity with cultured live EBOV and clinical samples from infected non-human primates. Comparison with a commercially available EBOV rapid diagnostic test that received emergency use approval demonstrates that the glycoprotein-specific LFI developed as a part of this study has improved sensitivity. The outcome of this work presents a diagnostic prototype with the potential to enable earlier diagnosis of EVD in clinical settings and provide healthcare workers with a vital tool for reducing the spread of disease during an outbreak.<br />Author summary Ebola virus (EBOV) causes a severe hemorrhagic fever and has an extremely high fatality rate that ranges from 60%-90%. There is no approved treatment or vaccine for this infectious disease and halting spread of the virus relies on identifying and isolating infected patients quickly. The current gold standard, polymerase chain reaction assay, requires patient samples be transported to regional reference laboratories where it often takes days to get results. A handful of Ebola rapid diagnostic tests have been developed, but lack the sensitivity required to detect the virus in earlier stages of the disease. There is great need for more sensitive rapid diagnostic tests that can identify the EBOV infected patients when they first become symptomatic. This study focused on production of high affinity mAbs to two target EBOV proteins for development of a more sensitivity rapid diagnostic test. Efforts have resulted in production of prototype detecting the EBOV glycoprotein that shows a notable improvement in sensitivity and offers the potential for earlier diagnosis of infection.
- Subjects :
- 0301 basic medicine
Zaire ebolavirus
RNA viruses
Physiology
RC955-962
medicine.disease_cause
Pathology and Laboratory Medicine
Polymerase Chain Reaction
Biochemistry
Disease Outbreaks
Mice
0302 clinical medicine
Viral Envelope Proteins
Immune Physiology
Arctic medicine. Tropical medicine
Medicine and Health Sciences
Enzyme-Linked Immunoassays
Antigens, Viral
Virus Testing
Immunoassay
Rapid diagnostic test
Immune System Proteins
Transmission (medicine)
Antibodies, Monoclonal
Ebolavirus
Infectious Diseases
Point-of-Care Testing
Medical Microbiology
Filoviruses
Viral Pathogens
Viruses
Democratic Republic of the Congo
Engineering and Technology
Female
Pathogens
Public aspects of medicine
RA1-1270
Ebola Virus
Viral load
Research Article
medicine.medical_specialty
Point-of-Care Systems
030231 tropical medicine
Immunology
Enzyme-Linked Immunosorbent Assay
Immunologic Tests
Research and Analysis Methods
Microbiology
Antibodies
Viral Matrix Proteins
03 medical and health sciences
Diagnostic Medicine
medicine
Animals
Humans
Prototypes
Intensive care medicine
Immunoassays
Microbial Pathogens
Point of care
Ebola virus
Biology and life sciences
business.industry
Diagnostic Tests, Routine
Hemorrhagic Fever Viruses
Public Health, Environmental and Occupational Health
Organisms
Outbreak
Proteins
Gold standard (test)
Hemorrhagic Fever, Ebola
Monoclonal Antibodies
030104 developmental biology
Technology Development
Immunologic Techniques
business
Subjects
Details
- Language :
- English
- ISSN :
- 19352735 and 19352727
- Volume :
- 14
- Issue :
- 11
- Database :
- OpenAIRE
- Journal :
- PLoS Neglected Tropical Diseases
- Accession number :
- edsair.doi.dedup.....647b36309242f2e861e5a2789ac118da