The U.S. Food and Drug Administration allowed marketing of a rapid diagnostic test (RDT) which will detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid).

The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for the Ebola Virus Disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed.

Todays marketing authorization provides another important tool in the effort to fight Ebola, which continues to be a priority of the U.S. Government, especially as we work with our partners, including the World Health Organization, to help address the current Ebola outbreak in the Democratic Republic of Congo (DRC), said Acting FDA Commissioner Ned Sharpless, M.D.

Ebola, in current outbreak in the Democratic Republic of Cango (DRC) has killed many thousands.It killed more than 11000 in West Africa since 2014.

Investigational vaccines and therapeutics have shown promising results in fighting Ebola outbreak.

Quick diagnosis is very important tool in identifying the victims of Ebola and taking appropriate action for live or dead victims.In fact dignified last rites are closely connected with proper diagnosis of victims.

The ability to use this test to promptly make a presumptive Ebola diagnosis could help providers to more quickly isolate patients and begin treatments that can be potentially life-saving. Additionally, this device could be used to support safe and dignified burials while helping to reduce the risk of transmission during those burials. said Ned Sharpless, M.D.

What is EVD ?

EVD, Ebola Virus Disease , which is caused by the Ebola virus, is a severe, often fatal disease in humans that can spread through direct contact with blood or body fluids or objects contaminated with body fluids, as well as from the bodies of those who have died from the virus.

EVD has led to several large outbreaks in Africa, including the West African Ebola epidemic that began in 2014 and was the largest outbreak of EVD in recorded history, and the ongoing outbreak in the DRC, which is currently the second largest outbreak.

What is being done to contain Ebola ?

For the OraQuick Ebola Test submission, the FDA reviewed data from multiple clinical studies of blood samples and cadaveric oral fluid from the 2014 West African outbreak and from a variety of analytical studies.

Based on these data, the FDA determined that general and special controls were necessary to provide a reasonable assurance of the safety and effectiveness of the OraQuick Ebola Test when intended to identify antigens associated with Ebola virus in blood from symptomatic patients and oral fluid of cadavers.

The amount of Ebola virus when patients have severe symptoms of EVD is usually high; however, the amount of virus in samples taken early after infection when symptoms are not present yet or taken early during the course of EVD when symptoms are mild can be very low.

The studies demonstrated the importance of testing only symptomatic individuals so that the amount of virus is high enough to be detectable by this test.

Therefore, the OraQuick Ebola Test is intended for use in patients suspected of and with signs or symptoms consistent with EVD, and when the patient meets the CDCs Ebola virus epidemiological criteria, such as history of residence in or travel to a geographic region with active EVD transmission at the time of travel.

The OraQuick Ebola Test is not intended to be used for general Ebola infection screening (e.g., airport screening) or testing of individuals at risk of exposure without observable signs of infection.

The OraQuick Ebola Test may also be used in recently deceased individuals (cadaveric oral fluid) with epidemiological risk factors (including geographic locations with high prevalence of EVD) suspected to have died of EVD to inform decisions on safe handling of cadavers to prevent disease transmission.

Negative results do not rule out Ebola virus infection. The definitive identification of EVD requires additional testing and confirmation procedures (such as by a more sensitive but less rapid polymerase chain reaction test) and in consultation with public health and/or other authorities to whom reporting is required.

The OraQuick Ebola Test was granted Breakthrough Device designation, meaning the FDA provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agencys review of the device.

What is Breakthrough Device designation by FDA ?

To qualify for such designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition, and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.