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Bio-Rad Laboratories is set to launch a blood-based immunoassay kit for the identification of antibodies to the SARS-CoV-2, the virus that causes Covid-19.
The company has established preliminary performance of the assay, which is currently being clinically evaluated in multiple hospitals to further confirm its performance.
Initial data has been collected on more than 700 samples and demonstrated the specificity of over 99%.
Bio-Rad Clinical Diagnostics Group executive vice-president 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.”
Viral antigens stimulate the immune system of the body to produce antibodies to fight the virus in case of SARS-CoV-2 infection.
Bio-Rad noted that its serology immunoassay kit will help clinicians diagnose Covid-19 by analysing the immune response against SARS-CoV-2.
The new immunoassay kit identifies IgG, IgM, and IgA, the complete immunoglobulin. This approach is considered to be more sensitive compared to assays against a single immunoglobulin.
Bio-Rad’s test is designed to be used manually or on an automated immunoassay platform, including its EVOLIS System. The system provides high-throughput processing and sample traceability.
The company plans to use the Food and Drug Administration’s (FDA) emergency use authorisation (EUA) process to expedite the availability of the assay in the US. It also intends to launch it globally.
In June 2017, Bio-Rad Laboratories received FDA clearance for its BioPlex 2200 Syphilis Total and RPR assay designed to diagnose syphilis infection.