PCR machines also expensive and run on electricity, which can be problematic in emerging or developing markets like West Africa. It can take up to 3 days after symptoms appear for virus to reach detectable levels, according to the US Centers for Disease Control and Prevention. So even if early sample is negative, later specimen may be needed to rule out Ebola, according to CDC.
Now, companies, government agencies and nonprofits focusing on development of diagnostics that can detect Ebola virus sooner after infection and deliver results more quickly after sample taken and closer to patient “point of care.”
Some of companies are designing low-cost tests with Africa in mind, but need government agencies for financial support to develop and deploy. Some machines will be expensive, and not clear how widely they’ll be made available outside of wealthy countries as opposed to Africa where needed the most.
BioFire’s FilmArray uses PCR technology, but can deliver results in about 1 hour on premises of any treatment facility that has one of their machines, which cost around US$39,000 apiece. Many US hospitals already have the machines, which were approved to diagnose pathogens including those causing gastrointestinal and respiratory diseases. FDA’s emergency clearance for Ebola testing should allow about 300 hospitals in the US that already own machines to use them to make Ebola diagnoses, and BioFire is expecting additional demand thanks to new Ebola use.
Denver-based Corgenix Medical Corp. is speeding up development of portable Ebola test kit designed to deliver results from drop of blood in about 10 minutes. It uses “lateral-flow” technology, which is similar to home pregnancy test, and doesn’t require electricity or machine to process sample. Paper strip displays one blue line if no virus is detected, two blue lines if virus is detected, and no lines if test didn’t work properly. Corgenix is working with Tulane University in New Orleans and other partners in the Viral Hemorrhagic Fever Consortium, with funding from NIH. Researchers testing Corgenix device, including in West Africa, but haven’t gathered enough data to apply for approval by either FDA or WHO. Corgenix expects test would cost about US$10 to $15, and NGOs would help pay for deployment.
Chembio Diagnostics Systems, Medford, NY, maker of rapid diagnostics for HIV and syphilis, formed partnership with Integrated BioTherapeutics in Gaithersburg, Md., to develop point-of-care test for Ebola. Plans to use substances known as “reagents,” developed by Integrated BioTherapeutics, for test. Goal is develop test that uses drop of blood drawn by finger-stick and delivers results in 20 minutes or less, costing <US10 per test.
San Diego-based Genalyte developing Ebola diagnostic that uses silicon chip to test drop of blood drawn with pinprick. Chip is processed through 15-inch-wide machine that delivers results in about 10 minutes.
Rapid diagnostics using oral fluid also could be useful tool. OraSure Technologies, Bethlehem, Pa. maker of oral test for HIV, exploring whether can develop rapid oral test for Ebola.
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