November, 2020: Chembio Diagnostics, Inc. a point-of-care diagnostic company has announced that its subsidiary Chembio Diagnostics Brazil Ltda. has received approval from Agência Nacional de Vigilância Sanitária (ANVISA) for the DPP SARS-CoV-2 Antigen test system in Brazil.
The Chembio's DPP SARS-CoV-2 Antigen test system is designed to detect SARS-CoV-2 antigens in only 20 minutes.
The identification of SARS-CoV-2 viral antigens indicates that the virus responsible for the COVID-19 cases is already infected. The system consists of a DPP Micro Reader 1, DPP Micro Reader 2 analyzer, DPP SARS-CoV-2 Antigen test cartridge and a minimally invasive nasal swab. The clinical trial data presented by the company indicates a sensitivity of 96.0 percent at zero to six days from the start of symptoms and 98.7 percent accuracy in the symptomatic population as compared to PCR tests.
With respect to the approval, Javan Esfandiari, Chembio’s Vice President and Chief Science & Technology Officer said in a company press release, “We are grateful for the rapid review and approval of our DPP SARS-CoV-2 Antigen assay by ANVISA. The exceptional performance of this assay highlights again the value and flexibility of our DPP technology. We believe helping people understand their infection status has shown to be one of the most effective methods for controlling the spread of COVID-19. Enabling patients and providers to know this information at the point-of-care in 20 minutes can help further reduce the risk of virus transmission and improve patient outcomes. We are very proud to offer this test in Brazil and assist in efforts to manage the global pandemic.”
Using a small drop of blood from the fingertip or alternative samples, Chembio's patented DPP technology platform offers high-quality, fast diagnostic results in 15 to 20 minutes. The DPP platform can detect up to eight distinct test results from a single patient sample by advanced multiplexing, providing greater clinical benefit than other rapid tests.