The FDA announced Nov. 9, it gave approval for emergency use of a new rapid, single-use fingerstick test for detecting Ebola in the midst of the Democratic Republic of the Congo's current Ebola outbreak.
Here are three things to know:
1. The FDA emergency use authorization allows the agency to authorize and use unapproved medical products when there are not adequate approved alternatives. The FDA's criteria for issuing the emergency use authorization is based on the reasonable belief that based on the total evidence available, the test may be effective and the benefits outweigh the potential risks.
The authorization "is part of the agency's ongoing efforts to help mitigate potential future threats by making medical products that have the potential to prevent or treat available as quickly as possible," said Scott Gottlieb, MD, commissioner of the FDA.
2. This is the second time an Ebola rapid antigen fingerstick test was made available in an emergency authorization. However, the new fingerstick test is the first to use a portable battery-operated reader, which provides a clear diagnosis. The DPP Ebola Antigen System reads capillary whole blood through a fingerstick with an anticoagulant. Due to the accessibility of the fingerstick test, it can be performed outside of laboratories and facilities where a healthcare provider does not have access to authorized Ebola tests (polymerase chain reaction testing), according to Medscape.
3. The FDA also indicated a negative result from the DPP Ebola Antigen System, particularly for patients exhibiting Ebola symptoms and signs, should be considered along with patient history, symptoms, signs and exposure likelihood in addition to laboratory evidence.
"Recent outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of an EUA for the DPP Ebola Antigen System is an important step in addressing these outbreaks," the FDA stated. said.
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