Kalorama: PCR The Go-to Test in Ebola Fight
NEW YORK, Oct. 27, 2014 /PRNewswire/ -- Kalorama Information says that PCR is demonstrating its worth in the recent Ebola concern in the United States and is the dominant test for the virus. The healthcare market researcher said the FDA's Emergency Use Authorization (EUA) to authorize the emergency use of in vitro diagnostic tests for the detection of the Ebola virus was an indication that the tests sensitivity has proved useful. Kalorama routinely assess the IVD industry and its biennial survey on diagnostics markets was recently released: The Worldwide Market for In Vitro Diagnostic Tests, 9th Edition (http://www.kaloramainformation.com/redirect.asp?progid=86776&productid=8326563).
As there are no FDA-approved/cleared tests that identify the existence of the Ebola virus, these tests – the Ebola Zaire (Target 1) Real-Time PCR (TaqMan®) (EZ1 rRT-PCR) Assay, CDC Ebola Virus NP Real-Time RT-PCR (EBOV NP rRT-PCR) Assay, and CDC Ebola Virus VP40 Real-Time RT-PCR (EBOV VP40 rRT-PCR) Assay – should be performed only on individuals with signs and symptoms of Ebola virus infection or who are at risk for exposure or may have been exposed to the Ebola Zaire virus, which has been detected in the West Africa outbreak.
"Right now, PCR – though it takes room, time and expense – is the way to test for Ebola when it is suspected because it is highly sensitive," said Bruce Carlson, Publisher of Kalorama Information. "Novel POC tests could improve care if they can be developed in time, but for the few cases and suspected cases, you are seeing samples sent to labs with PCR capability."
Global concerns regarding the possible spread of Ebola from West Africa underscore the importance of diagnostic testing. Kalorama Information's The Worldwide Market for In Vitro Diagnostic Tests tracks hundreds of companies in the in vitro diagnostic testing industry for developments, trends and financial results. This research is compiled along with the opinion, observations and insights of industry experts to produce an unparalleled vision of the industry as it is in 2014. The report also provides a realistic forecast five years into the future for companies already participating in or considering entry into this growing industry.
PCR Ebola tests are not without challenges. Results take five hours to achieve, and are sent away to local CDC-approved facilities that can perform the test and provide a result to the healthcare provider. They are therefore impractical in settings such as airports. In addition, tests can generate false positives and false negatives. negative test results themselves do not necessarily rule out Ebola, and so PCR cannot be used as the sole basis for treatment or other patient management decisions. A negative test may simply mean that Ebola virus RNA was not present in the specimen at the detection level of the assay.
There is no vaccine for Ebola, though three potential vaccines are now being fast-tracked through early safety trials in volunteers in the UK, the US and Mali. If the trials yield an acceptable vaccine, healthcare workers could be offered vaccinations before year's end. The only proof that any vaccine works will be if there is a significant drop in the number of deaths among vaccinated caregivers.
"Lacking a vaccine, the true frontline in the medical battle against Ebola is diagnostic testing," Carlson said.
The Worldwide Market for In Vitro Diagnostic Tests report contains detailed profiles of the top players in in vitro diagnostics. Profiling in this report describes the developments in each significant division of their business. A number of secondary players are also extensively profiled, as well as specialty companies with expertise in one testing area. Information on the report can be found at KI: http://www.kaloramainformation.com/redirect.asp?progid=86776&productid=8326563.
About Kalorama Information -- Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog.
Contact:
Bruce Carlson
(212) 807-2622
[email protected]
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SOURCE Kalorama Information
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