Bio-Rad Laboratories, a provider of clinical diagnostic products, is set to introduce a serology assay for the detection of novel coronavirus antibodies.
The company’s blood-based immunoassay kit will help detect antibodies to the novel coronavirus SARS-CoV-2, the virus responsible for the COVID-19.
The serology assay is currently undergoing clinical assessment in various hospitals to further confirm clinical performance
Bio-Rad has already completed the preliminary performance of the assay and is currently undergoing clinical assessment in various hospitals to further confirm clinical performance.
According to the company, the initial data collected from more than 700 samples have shown a specificity of above 99%.
The viral antigens stimulate the immune system of the body to produce antibodies to eliminate the virus, after infection with SARS-CoV-2.
The immunoassay kit helps to identify total immunoglobulin, including IgG, IgM, and IgA, an approach that is more sensitive than assays against a single immunoglobulin.
Bio-Rad has designed the test to use manually or on an automated immunoassay platform such as the company’s EVOLIS system.
Bio-Rad aims to distribute the immunoassay kit across the globe. The company intends to use the FDA’s emergency use authorisation process to advance the availability of the test in the US.
Bio-Rad clinical diagnostics group EVP and president Dara Wright said: “Using a serology test to support the diagnosis of COVID-19 and to screen populations can provide a more complete understanding of infection rates as well as immunity.
“The detection of antibodies to SARS-CoV-2 on a large scale may be used to guide public authorities in their decisions to lift partial or total containment orders according to the serological status of the population. Molecular and serology testing are highly complementary in this regard.”
In April 2019, Bio-Rad secured approval from the FDA for its BioPlex 2200 Lyme Total assay, which is an advanced multiplex test method that will be used in the diagnosis of Lyme disease.
Bio-Rad is engaged in the development, manufacturing and marketing of a range of advanced products for the life science research and clinical diagnostic markets.-NS Medical Devices