Open AccessUltrasensitive point-of-care immunoassay for secreted glycoprotein detects Ebola infection earlier than PCR
Author(s) -
Cassio M. Fontes,
Barbara D. Lipes,
Jason Liu,
Krystle N. Agans,
Aiwei Yan,
Patricia Shi,
Daniela F. Cruz,
Garrett Kelly,
Kelli M. Luginbuhl,
Daniel Y. Joh,
Stephanie L. Foster,
Jacob T. Heggestad,
Angus Hucknall,
Maiken H. Mikkelsen,
Carl F. Pieper,
Roarke Horstmeyer,
Thomas W. Geisbert,
Michael D. Gunn,
Ashutosh Chilkoti
Publication year - 2021
Publication title -
science translational medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.819
H-Index - 216
eISSN - 1946-6242
pISSN - 1946-6234
DOI - 10.1126/scitranslmed.abd9696
Subject(s) - ebola virus , ebolavirus , virology , immunoassay , outbreak , medicine , point of care , ebola hemorrhagic fever , disease , point of care testing , polymerase chain reaction , immunology , biology , antibody , pathology , gene , biochemistry
Ebola virus (EBOV) hemorrhagic fever outbreaks have been challenging to deter due to the lack of health care infrastructure in disease-endemic countries and a corresponding inability to diagnose and contain the disease at an early stage. EBOV vaccines and therapies have improved disease outcomes, but the advent of an affordable, easily accessed, mass-produced rapid diagnostic test (RDT) that matches the performance of more resource-intensive polymerase chain reaction (PCR) assays would be invaluable in containing future outbreaks. Here, we developed and demonstrated the performance of a new ultrasensitive point-of-care immunoassay, the EBOV D4 assay, which targets the secreted glycoprotein of EBOV. The EBOV D4 assay is 1000-fold more sensitive than the U.S. Food and Drug Administration-approved RDTs and detected EBOV infection earlier than PCR in a standard nonhuman primate model. The EBOV D4 assay is suitable for low-resource settings and may facilitate earlier detection, containment, and treatment during outbreaks of the disease.