CINCINNATI, Oct. 13, 2020 /PRNewswire/ -- VEO Diagnostics announces the launch and sole distribution rights in the United States to the ACCEL ELISA® COVID-19 kit, a serological microplate-based enzyme linked immunosorbent assay (ELISA) for the qualitative detection of total antibodies (including IgG, IgM, and IgA) to SARS-CoV-2 in human serum. ACCEL ELISA® is intended for use as an aid in identifying individuals with an adaptive immune response to SARS CoV-2, which may indicate recent or prior infection.
The patented serology test developed and manufactured by Plexense, Inc. combines a proprietary and unique microwell design with advanced surface chemistry and reagent formulation to create an innovative platform designed to maximize testing speed and sensitivity. ACCEL ELISA® improves overall test turn-around time by reducing total incubation time to 30 minutes.
The total antibody test kit identifies three antibody subclasses (IgG, IgM, IgA) that the human body creates to attack the SARS-CoV-2 virus nucleocapsid protein. Research shows that the detection of antibodies to nucleocapsid protein is more sensitive than antibodies to spike protein in patients with early SARS-CoV-2 infection (Burbelo et al., 2020).
"Rethinking the well design and reformulating the surface chemistry completely change well-established ELISA technology, a long-appreciated approach to antibody detection," said Lon Hatamiya, CEO of PlexenseBIO, Inc. "While ELISA technology may no longer be considered innovative, our approach to microwell testing certainly is."
ACCEL ELISA® is permitted for sale under the notification process allowed by the FDA Emergency Use Authorization pathway in the US. It is now available to laboratories, healthcare systems and clinics in the US, Asia and Europe.
"The ACCEL ELISA® is a game-changer in detection of total antibodies to COVID-19 and will allow the US to more quickly test and broadly monitor wide-ranging populations to inform evidence-based policy and mitigation actions," said Ron Gilliland, CEO of VEO Diagnostics.
The ACCEL ELISA® kit is a simplified enzyme-linked immunosorbent assay designed for the sensitive, rapid, and qualitative detection of human SARS-CoV-2 antibodies.
- Positive Percent Agreement (i.e. Sensitivity): 100%
- Negative Percent Agreement (i.e. Specificity): 98.5%
- Unique well design: improves likelihood of detection with a 68% increase in microwell surface area versus comparable ELISA tests
- Rapid Testing - 30 minutes total incubation time
- Efficiency - 96-well strip plate allows testing of up to 94 samples (plus 2 controls) at a time
- Flexibility - Plate can be separated into strips of 8 wells for smaller test run
- Compatible with standard microplate readers (650nm)
- Detects total antibodies: including IgG, IgM, and IgA
VEO Diagnostics, based in Ohio, is dedicated to providing innovative medical diagnostic products and services to healthcare providers nationwide, including hospitals, laboratories, and other healthcare organizations, that assist in improving patient care while strictly adhering to regulatory and quality standards. VEO Diagnostics is the sole distributor and service provider of ACCEL ELISA® in the US.
Plexense, an immunoassay platform developer serving customers worldwide, specializes in the development and production of rapid and cost-effective immunoassays and is headquartered in Sacramento, California and Yongin, South Korea. Since its founding in 2012, Plexense, Inc. has collaborated with major healthcare systems, US federal agencies, and various South Korean health and biological research and governmental agencies to develop advanced early diagnostic kits for clinical, agricultural and biological testing.
CONTACT: Deb Titlebaum, [email protected]
SOURCE VEO Diagnostics