Point-of-care diagnostics firm Chembio Diagnostics has secured emergency use authorization from the US Food and Drug Administration (FDA) for its Ebola virus diagnostic test.


Image: Ebola virus virion. Photo: courtesy of Martin H.

Chembio said the EUA status has been provided for the DPP Ebola antigen system for use with human capillary fingerstick whole blood, EDTA venous whole blood and EDTA plasma.

The DPP Ebola antigen system is comprised of DPP Ebola assay and DPP micro reader. It Chembio’s patented DPP technology platform, which is the same technology used in the firm’s FDA approved HIV antibody tests and FDA authorized DPP Zika system.

Chembio’s virus diagnostic test holds capacity to detect viral antigens and offers qualitative results within 15 to 20 minutes when used with the hand-held and battery-operated DPP micro reader Reader to reduce the risk of human error during test interpretation.

The company secured authorization for the test for the presumptive detection of Ebola virus in individuals with signs and symptoms of Ebola virus disease (EVD) in conjunction with epidemiological risk factors.

The DPP Ebola antigen system can be used in laboratories or facilities, including treatment centers and public health clinics.

In 1976, Ebola virus disease was first discovered near the Ebola River. EVD is an acute, severe and fatal illness that may result in sudden onset of fever, fatigue, muscle pain, headache and sore throat.

As per the World Health Organization, it can be difficult to clinically distinguish EVD from other infectious diseases such as malaria.

The DPP Ebola antigen system has not been approved by the FDA and was authorized only for the diagnosis of EVD and not for any other viruses or pathogens.

Chembio CEO John Sperzel said: “We are pleased to receive FDA Emergency Use Authorization for our DPP Ebola System as we believe it will be a valuable tool to address the global threat posed by Ebola virus, including the ongoing outbreak in the DRC.

“Our patented DPP technology continues to serve as a robust platform for the rapid detection of infectious diseases, and we hope to receive support and funding as we pursue additional regulatory approvals for our rapid Ebola test.”