We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

LabMedica

Download Mobile App
Recent News Expo Clinical Chem. Molecular Diagnostics Hematology Immunology Microbiology Pathology Technology Industry Focus

Ebola Test with Portable Reader Authorized for Emergency Use

By LabMedica International staff writers
Posted on 26 Nov 2018
authorization (Photo courtesy of Chembio Diagnostic Systems).
authorization (Photo courtesy of Chembio Diagnostic Systems).
Ebola is a rare but deadly virus that causes fever, body aches, and diarrhea, and sometimes bleeding inside and outside the body. As the virus spreads through the body, it damages the immune system and organs. Ultimately, it causes levels of blood-clotting cells to drop. This leads to severe, uncontrollable bleeding and kills up to 90% of people infected.

The disease is spread from human to human is through contact with blood and/or bodily fluids (urine, saliva, feces, vomit, sweat, breast milk and semen) of infected individuals. This may be through direct contact and/or droplet spread (droplets of infected bodily fluids produced by sneezing, coughing or talking) or via objects (such as needles) and environments that have been contaminated with the virus.

The US Food and Drug Administration (FDA, Silver Springs, MD, USA) issued an emergency use authorization (EUA) for a rapid, single-use test for the detection of Ebola virus (Zaire Ebola virus). 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 (Chembio Diagnostic Systems Inc, Medford, NY, USA) 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 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.

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.

Related Links:
US Food and Drug Administration
Chembio Diagnostic Systems

New
Gold Member
Hybrid Pipette
SWITCH
Collection and Transport System
PurSafe Plus®
Human Estradiol Assay
Human Estradiol CLIA Kit
New
Gold Member
Automatic Chemiluminescence Immunoassay Analyzer
Shine i2000

Channels

Hematology

view channel
Image: New evidence shows viscoelastic testing can improve assessment of blood clotting during postpartum hemorrhage (Photo courtesy of 123RF)

Viscoelastic Testing Could Improve Treatment of Maternal Hemorrhage

Postpartum hemorrhage, severe bleeding after childbirth, remains one of the leading causes of maternal mortality worldwide, yet many of these deaths are preventable. Standard care can be hindered by delays... Read more

Immunology

view channel
Image: The CloneSeq-SV approach can allow researchers to study how cells within high-grade serous ovarian cancer change over time (Photo courtesy of MSK)

Blood Test Tracks Treatment Resistance in High-Grade Serous Ovarian Cancer

High-grade serous ovarian cancer (HGSOC) is often diagnosed at an advanced stage because it spreads microscopically throughout the abdomen, and although initial surgery and chemotherapy can work, most... Read more

Industry

view channel
Image: Private equity firms Blackstone and TPG have joined forces to acquire Hologic in a major healthcare deal (Photo courtesy of Hologic)

Hologic to be Acquired by Blackstone and TPG

Hologic (Marlborough, MA, USA) has entered into a definitive agreement to be acquired by funds managed by Blackstone (New York, NY, USA) and TPG (San Francisco, CA, USA) in a transaction valued at up to... Read more