Chembio secures FDA EUA authorization for Ebola virus diagnostic test

Point of care (POC) diagnostics firm Chembio Diagnostics gets an emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its new Ebola virus diagnostic test.

Chembio’s patented DPP technology platform, is the same technology used in the its FDA approved HIV antibody tests and FDA authorized DPP Zika system. The 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 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.

However, the 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.



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