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April 8, 2020updated 02 Nov 2021 8:51am

Bio-Rad to launch blood-based immunoassay kit to detect Covid-19

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.


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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 F ood and Drug Administration’s (F DA) 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 F DA clearance for its BioPlex 2200 Syphilis Total and RPR assay designed to diagnose syphilis infection.

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COVID-19 has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities. Are you interested in actionable insights on the business challenges induced by the pandemic? GlobalData's cross-sector report analyzes the significance of this major disruptive theme across industry verticals. It provides side-by-side research of alternative datasets to present you with unique quantitative analysis of the effects of COVID-19 and how these differ across sectors. Additionally, it offers qualitative analysis of each sector and analyzes COVID-19’s impact on leading companies. Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today.
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