New Emergency-Use Listed Kit Provides Rapid Diagnostic Test for Ebolavirus

The EUAL program is part of the continued global response to help in early-treatment of patients and prevent spread of infection, particularly in the West Africa outbreak that has had a mortality rate of over 40%.

In October 2014, WHO released a request for diagnostic medical device companies to develop a rapid in vitro diagnostic (IVD) test for Ebolavirus disease (EVD). In response, SD Biosensor, Inc. (GyeongGi-do, Republic of Korea) has completed development and six months of official WHO clinical evaluation for its “SD Q Line Ebola Zaire Ag” assay. On September 8, 2015, the kit qualified for WHO’s EUAL listing. While 19 companies participated for EUAL, only 2 were chosen.

The kit uses 3 mouse monoclonal antibodies specific for Zaire Ebolavirus antigens: glycoprotein(GP), nucleoprotein(NP), viral matrix protein(VP40). The high-quality kit tests samples of whole blood, plasma, or serum: sensitivity on whole blood and plasma (n=126) 84.9% (95% CI) (78.6–91.2); specificity on whole blood and plasma (n=289) 99.7 % (95% CI) (99.1–100.0). In cooperation with WHO to reduce risk of Ebola and other infections and to improve convenience, SD Biosensor is pursuing further development for saliva samples.

In addition to Ebolavirus detection, SD Biosensor has recently developed a rapid IVD kit for Middle East respiratory syndrome coronavirus (MERS-CoV virus) [Betacoronavirus spp.] in humans, based on a successful veterinary test developed by Bionote, Inc., subsidiary of SD Biosensor. The human test kit is currently undergoing clinical evaluation.

Related Links:
SD Biosensor, Inc.
WHO report on the SD Q Line Ebola Zaire Ag kit (pdf file)