Chembio Diagnostics Announces CE Mark for DPP SARS-CoV-2 Antigen and IgM/IgG Test Systems - Seite 2

IgM and IgG antibody test results assist clinicians in determining current or past exposure to the COVID-19 virus. The results and data from the test can contribute to improved clinical outcomes through management of individual patients, use as a population surveillance tool, and potentially evaluation of immune responses to vaccine administration.

Brendan Farrell, Chief Executive Officer of Luas Diagnostics, commented, “We are excited to form a partnership with Chembio and look forward to marketing and selling their range of rapid tests into the United Kingdom and Irish markets. We see enormous potential for Chembio’s rapid antigen and antibody products and DPP multiplex solutions, where testing can be performed rapidly, accurately, and with limited training.”

About the DPP Rapid Test Platform
Chembio’s proprietary DPP technology platform provides high-quality, rapid diagnostic results in 15 to 20 minutes using a small drop of blood from the fingertip or alternative samples. Through advanced multiplexing, the DPP platform can detect up to eight, distinct test results from a single patient sample, delivering greater clinical value than other rapid tests. For certain applications, Chembio’s easy-to-use, highly portable, battery-operated DPP Micro Reader optical analyzer then reports accurate results in approximately 15 seconds, making it well-suited for decentralized testing where real-time results enable patients to be clinically assessed while they are still on-site. Objective results produced by the DPP Micro Reader reduce the possibility of the types of human error that can be experienced in the visual interpretations required by many rapid tests.

Chembio’s portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA). Additionally, DPP-based tests have received regulatory approvals from the World Health Organization, CE-Mark, Agência Nacional de Vigilância Sanitária (ANVISA), and other global organizations, where they aid in the detection and diagnosis of several other critical diseases and conditions.