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Chembio Diagnostics Receives FDA Clearance for Zika Virus Antibody Detection System

NEW YORK – Chembio Diagnostics announced Monday its DPP Zika IgM System, which includes the DPP Zika IgM Assay and DPP Micro Reader, has received 510(k) clearance from the US Food and Drug Administration.

The system is meant to detect Zika virus IgM antibodies in human serum, potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens within 15 minutes. Patients must meet the Zika virus clinical or epidemiological criteria from the US Centers for Disease Control and Prevention in order to be tested.

The DPP Micro Reader is a handheld portable analyzer that works with all of Chembio's DPP tests, and this FDA clearance is the initial US regulatory approval for the analyzer, Chembio said in a statement.

The system was developed partially thanks to a $5.9 million contract from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority. In 2017, the system received Emergency Use Authorization to help deal with the spread of Zika virus. Chembio also received a $1.5 million conditional long-term arrangement from UNICEF to purchase the DPP Zika/Chikungunya/Dengue System, which includes the DPP Zika/Chikungunya/Dengue IgM/IgG multiplex test.