Blood drop
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Chembio Diagnostics, Inc.’s DPP® Zika System.
The system includes the DPP Zika IgM Assay, which enables in vitro qualitative detection of human IgM antibodies to Zika virus, and the DPP Micro Reader, which is a portable, hand-held device intended to reduce the risk of human error during test interpretation.
The DPP Zika System provides results in 15 to 20 minutes from 10 µL of blood.
The system is designed to detect Zika virus IgM antibodies in finger-stick whole blood, EDTA venous whole blood, EDTA plasma (each collected alongside a patient-matched serum specimen), or serum (plain or separation gel) specimens.
The EUA for the DPP Zika System does not mean it is FDA cleared or approved.
An EUA allows for the use of unapproved medical products (or unapproved uses of approved medical products) in an emergency. The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.
The EUA for the DPP Zika System means the test is only authorized as long as circumstances exist to justify the emergency use of in vitro diagnostics for the detection of Zika virus, unless the authorization is terminated or revoked sooner.
Testing using the DPP Zika System is authorized to be conducted by laboratories in the US that are certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-US laboratories.
The DPP Zika System can be used to test individuals who meet the Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (eg, a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (eg, a history of residence in or travel to a geographic region with active Zika transmission at the time of travel or other epidemiological criteria for which Zika virus testing may be indicated).
The DPP Zika System can be used starting 8 days after symptom onset or risk of exposure and for up to 12 weeks after that point.
Where there are reactive results from the DPP Zika IgM Assay, confirmation of the presence of anti-Zika IgM antibodies requires additional testing and/or consideration alongside test results for other patient-matched specimens using the latest CDC testing algorithms for the diagnosis of Zika virus infection.
Development of the DPP Zika System has been funded, in part, with federal funds from the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services.
Chembio Diagnostics, Inc. has been awarded a contract for $5.9 million to develop the product and obtain EUA and 510(k) clearance from the FDA, with the potential of $13.2 million in total funding from BARDA if all options are exercised, to advance clinical development of the DPP Zika System and DPP® Zika/Dengue/Chikungunya System.
More information on the DPP Zika System and other Zika tests granted EUAs can be found on the FDA’s EUA page.
