Breaking News
February 23, 2019 - U.S.-based patient advocacy organizations received majority of pharma donations, finds study
February 23, 2019 - UCL and AIIMS collaborates to increase academic and student exchange
February 23, 2019 - Mechanism behind how diabetes causes muscle loss revealed
February 23, 2019 - Hepatocellular carcinoma diagnosis, prognosis and treatment may improve by identifying a protein
February 23, 2019 - The American Heart Association issues new reference toolkit for healthcare providers
February 23, 2019 - Studies explore physiological dangers that climate change will have on animal life
February 23, 2019 - Penn study reveals increase in health-related internet searches before ER visits
February 23, 2019 - Intensive therapy during early stages of MS leads to better long-term outcomes
February 23, 2019 - Prenatal Fluconazole Exposure Increases Neonatal Risks
February 23, 2019 - Mental Health Screening: MedlinePlus Lab Test Information
February 23, 2019 - Study suggests birth mechanics are part of the process that leads to autism
February 23, 2019 - Unhealthy diet linked to poor mental health
February 23, 2019 - Study gives a snapshot of crocodile evolution
February 23, 2019 - Research finds steep rise in self-poisonings among young people
February 23, 2019 - American Gastroenterological Association announces “AGA Future Leaders Program”
February 23, 2019 - Scientists uncover new mechanisms regulating neural stem cells
February 23, 2019 - Combinations of certain insecticides turn out to be lethal for honeybees
February 23, 2019 - AHA News: Why Are Black Women at Higher Risk of Dying From Pregnancy Complications?
February 23, 2019 - NIMH » Anxiety Disorders
February 23, 2019 - Autistic people urgently need access to tailored mental health support
February 23, 2019 - Newly designed molecule could benefit people with Friedrich’s Ataxia
February 23, 2019 - Chinese CRISPR twins may have better cognition and memory
February 23, 2019 - Study finds new genetic clues associated with asthma in African ancestry populations
February 23, 2019 - Fetal signaling pathways may offer future opportunities to treat lung damage
February 23, 2019 - Early-stage osteoarthritis drug wins prestigious innovation award
February 23, 2019 - Researchers report positive findings with dasotraline for ADHD in children ages 6-12
February 23, 2019 - News study reanalyzes the effects of noncaloric sweeteners on gut microbiota
February 23, 2019 - New device allows scientists to reproduce blow effects on the heart in lab
February 23, 2019 - Holy herb identified as a potential treatment for Alzheimer’s disease
February 23, 2019 - New technology platform digitally counts growth factors in single cells
February 23, 2019 - Physicians still remain at higher risk for burnout compared to other professionals
February 23, 2019 - Surgery and other treatments offer viable options for adult scoliosis
February 23, 2019 - Reduced antibody adaptability may make the elderly more vulnerable to influenza
February 23, 2019 - Researchers find increased rates of CRC screening in Kentucky after Medicaid expansion
February 23, 2019 - Neighborhood income, education associated with risk of disability progression in MS patients
February 23, 2019 - Endocrine Society opposes new rule that restricts access to Title X Family Planning Program
February 23, 2019 - 2019 guidelines for management of patients with atrial fibrillation
February 23, 2019 - Surprise rheumatoid arthritis discovery points to new treatment for joint inflammation
February 23, 2019 - A just-right fix for a tiny heart
February 23, 2019 - UMass Amherst scientist explores role of citrus peel in decreasing gut inflammation
February 23, 2019 - Owlstone Medical and Shanghai Renji Hospital collaborate to initiate breath biopsy lung cancer trial
February 23, 2019 - AMSBIO’s comprehensive portfolio of knock-out cell lines and lysates
February 23, 2019 - New app reliably determines physicians’ skills in forming accurate, efficient diagnoses
February 23, 2019 - Peripheral nerve injury can trigger the onset and spread of ALS, shows study
February 23, 2019 - Researchers uncover mechanisms that prevent tooth replacement in mice
February 23, 2019 - Once-a-day capsule offers new way to reduce symptoms of chronic breathlessness
February 23, 2019 - FDA Adds Boxed Warning for Increased Risk of Death with Gout Medicine Uloric (febuxostat)
February 23, 2019 - Phone-based intervention aids rheumatoid arthritis care
February 23, 2019 - Opioid epidemic makes eastern inroads and targets African-Americans
February 23, 2019 - New identified biomarker predicts patients who might benefit from HER2-targeted agents
February 23, 2019 - Study offers new insights into mechanisms of changes in erythrocytes under stress
February 23, 2019 - Antipsychotic polypharmacy may be beneficial for schizophrenia patients
February 23, 2019 - Researchers investigate how marijuana and tobacco co-use affects quit attempts by smokers
February 23, 2019 - Patients with diabetes mellitus have high risk of stable ischemic heart disease
February 23, 2019 - Transparency on healthcare prices played key role in Arizona health system’s turnaround
February 23, 2019 - A comprehensive, multinational review of peppers around the world
February 23, 2019 - Study finds modest decrease in burnout among physicians
February 23, 2019 - A simple change can drastically reduce unnecessary tests for urinary tract infections
February 23, 2019 - Deep Learning-Enhanced Device Detects Diabetic Retinopathy
February 23, 2019 - Researchers discover new binding partner for amyloid precursor protein
February 23, 2019 - Modest decrease seen in burnout among physicians, researchers say | News Center
February 23, 2019 - Transplanting bone marrow of young mice into old mice prevents cognitive decline
February 23, 2019 - Mogrify to accelerate novel IP and cell therapies using $3.7m USD funding
February 23, 2019 - Johns Hopkins study describes cells that may help speed bone repair
February 23, 2019 - Scientists demonstrate influence of food odors on proteostasis
February 23, 2019 - Researchers unlock the secret behind reproduction of fish called ‘Mary’
February 23, 2019 - Acupuncture Could Help Ease Menopausal Symptoms
February 23, 2019 - Researchers use AI to detect early signs of Alzheimer’s
February 23, 2019 - On recovery, vulnerability and ritual: An exhibit in white | News Center
February 23, 2019 - Memory Stored in Unexpected Region of the Brain
February 23, 2019 - Several health experts worldwide gather at EUDONORGAN event
February 23, 2019 - Discovery of potent compound in native California shrub may lead to treatment for Alzheimer’s
February 22, 2019 - Researchers create new map of the brain’s own immune system
February 22, 2019 - ICHE’s reviews on surgical infections, unnecessary urine tests, and nurses’ role in antibiotic stewardship
February 22, 2019 - UK Research and Innovation invests £200 million to create new generation of AI leaders
February 22, 2019 - Takeda collaboration to boost fight against Alzheimer’s and other neurodegenerative diseases
February 22, 2019 - Heavy drinking may change DNA, leading to increased craving for alcohol
February 22, 2019 - U.S. opioid deaths jump fourfold in 20 years; epidemic shifts to Eastern states | News Center
February 22, 2019 - 5 Questions with William Turner on Diversity in Medicine
February 22, 2019 - HHS Finalizes Rule Seeking To Expel Planned Parenthood From Family Planning Program
FDA announces emergency use authorization of Ebola fingerstick test with portable reader

FDA announces emergency use authorization of Ebola fingerstick test with portable reader

image_pdfDownload PDFimage_print

Today, the U.S. Food and Drug Administration announced that an emergency use authorization (EUA) has been issued for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated.

The test, called the DPP Ebola Antigen System, is used with blood specimens, including capillary “fingerstick” whole blood, from individuals with signs and symptoms of Ebola virus disease (EVD) in addition to other risk factors, such as living in an area with large numbers of EVD cases and/or having contact with other individuals exhibiting signs and symptoms of EVD.

“The scourge of Ebola tragically demonstrates that we’re a global community when it comes to public health protection. Infectious disease doesn’t recognize nation states. Bacteria and viruses don’t respect territorial boundaries. It takes a sustained, robust and globally coordinated effort to protect our nation and the global community from various infectious disease threats. We’re all in this together. To that end, our FDA team of experts in drugs, vaccines and diagnostics continue to collaborate with our Federal, international and industry partners to employ our collective expertise, experiences from previous incidents, and resources to assist in the global response to the Ebola outbreak in the Democratic Republic of Congo,” said FDA Commissioner Scott Gottlieb, M.D. “This EUA is part of the agency’s ongoing efforts to help mitigate potential, future threats by making medical products that have the potential to prevent, diagnosis or treat available as quickly as possible. We’re committed to helping the people of the DRC effectively confront and end the current Ebola outbreak. By authorizing the first fingerstick test with a portable reader, we hope to better arm health care providers in the field to more quickly detect the virus in patients and improve patient outcomes.”

The FDA’s EUA authority allows the agency to authorize the use of an unapproved medical product, or the unapproved use of an approved medical product when, among other circumstances, there are no adequate, approved and available alternatives. When circumstances exist justifying authorization, the EUA becomes an important mechanism that allows broader access to medical products that have not been FDA cleared or approved and are instead only authorized for use for the duration of an emergency declaration. The FDA’s criteria for issuing an EUA for a diagnostic test includes making an assessment that it is reasonable to believe, based on the totality of evidence available to the agency, that the test may be effective and the known and potential benefits of using the test outweigh its known and potential risks.

In 2014, during the Ebola outbreak in West Africa, an emergency was declared by the Secretary of Health and Human Services. While that outbreak has ended, ongoing, smaller Ebola outbreaks have continued, and the emergency declaration is still in place. 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 DPP Ebola Antigen System provides rapid diagnostic results with tests that can be performed in locations where a healthcare provider does not have access to authorized Ebola virus nucleic acid tests (PCR testing), which are highly sensitive but can only be performed in certain laboratory settings that are adequately equipped. The DPP Ebola Antigen System has been authorized for use with capillary “fingerstick” whole blood, ethylenediaminetetraacetic acid (EDTA, an anticoagulant added to whole blood to prevent coagulation) venous whole blood and EDTA plasma. The DPP Ebola Antigen System should only be run in facilities, including treatment centers and public health clinics where patients are likely to be treated, and laboratories that are adequately equipped, trained and capable of such testing.

While today’s action will increase access to diagnostic tools for healthcare providers who may not have otherwise been equipped to perform tests, it is important to note that a negative result from the DPP Ebola Antigen System, especially in patients with signs and symptoms of EVD, should not be used as the sole basis for patient management decisions. The diagnosis of EVD must be made based on multiple factors such as, history, signs, symptoms, exposure likelihood and other laboratory evidence in addition to the detection of Ebola virus.

The FDA remains committed to using its authorities and resources to advance the development of countermeasures to address emerging threats and recently outlined its efforts to help address Ebola virus outbreaks. The FDA will continue to work with its federal partners and potential commercial product manufacturers in the most expedited manner to increase the availability of authorized diagnostic tests for Ebola virus disease for emergency use during this and any future outbreak.

With the issuance of the EUA for the DPP Ebola Antigen System to Chembio Diagnostic Systems Inc., the FDA has now issued EUAs for nine nucleic acid tests and two rapid diagnostic tests for Ebola virus detection in human specimens.

Source:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625502.htm

Tagged with:

About author

Related Articles